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Effects of Salmeterol on Autonomic Nervous System (ESAN)

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ClinicalTrials.gov Identifier: NCT01536587
Recruitment Status : Completed
First Posted : February 22, 2012
Results First Posted : February 4, 2014
Last Update Posted : April 11, 2014
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Pulmonary Disease, Chronic Obstructive
Intervention Drug: Salmeterol
Enrollment 32
Recruitment Details  
Pre-assignment Details At Visit 1, a complex data registration was performed during which placebo and 50 micrograms (µg) salmeterol via SEREVENT DISKUS inhaler was administered sequentially. Following Visit 1, participants were treated with salmeterol 50 µg twice daily (BID) via DISKUS inhaler for 4 weeks.
Arm/Group Title Salmeterol 50 µg BID
Hide Arm/Group Description Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
Period Title: Overall Study
Started 32
Completed 30
Not Completed 2
Reason Not Completed
Adverse Event             2
Arm/Group Title Salmeterol 50 µg BID
Hide Arm/Group Description Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
Overall Number of Baseline Participants 32
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 32 participants
61.19  (8.41)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants
Female
11
  34.4%
Male
21
  65.6%
1.Primary Outcome
Title Change in Muscle Sympathetic Nerve Activity (MSNA) at 2 Hours (Week 0)
Hide Description Human MSNA is composed of vasoconstrictor impulses grouped in pulse synchronous bursts that usually occur in sequences, preferentially during transient reductions of blood pressure. Sympathetic activity was measured using microneurographic recordings of efferent in the peroneal nerve. MSNA reflects sympathetic discharge to the vascular bed of the skeletal muscle. The change in MSNA (bursts per 100 heart beats [bursts/100 heart beats]) was calculated as the difference in MSNA change from Baseline to after the inhalation of salmeterol (2 hours, Week 0, Visit 1) minus the MSNA change from Baseline to after the inhalation of placebo (1 hour, Week 0, Visit 1).
Time Frame Baseline and 2 hours (Week 0)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-MSNA Population: all participants who received at least one dose of study medication and who had a valid data registration period of the primary endpoint.
Arm/Group Title Salmeterol 50 µg BID
Hide Arm/Group Description:
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: Bursts/100 heart beats
-1.3  (8.13)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Salmeterol 50 µg BID
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5062
Comments [Not Specified]
Method paired t-Test, 2-sided
Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in MSNA (Evaluated by Microneurography as Bursts/100 Heart Beats) at Week 4
Hide Description Human MSNA is composed of vasoconstrictor impulses grouped in pulse synchronous bursts that usually occur in sequences, preferentially during transient reductions of blood pressure. Sympathetic activity was measured using microneurographic recordings of efferent in the peroneal nerve. MSNA reflects sympathetic discharge to the vascular bed of the skeletal muscle. Change in MSNA is expressed in terms of bursts per 100 heart beats (bursts/100 heart beats). Change from Baseline was calculated as the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).
Time Frame Baseline and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-MSNA Population. Only those participants available at the indicated time points were assessed.
Arm/Group Title Salmeterol 50 µg BID
Hide Arm/Group Description:
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: Bursts/100 heart beats
-3.1  (11.58)
3.Secondary Outcome
Title Change From Baseline in MSNA (Evaluated by Microneurography as Bursts/Minute) at 2 Hours (Week 0)
Hide Description Human MSNA is composed of vasoconstrictor impulses grouped in pulse synchronous bursts that usually occur in sequences, preferentially during transient reductions of blood pressure. Sympathetic activity was measured using microneurographic recordings of efferent in the peroneal nerve. MSNA reflects sympathetic discharge to the vascular bed of the skeletal muscle. The change in MSNA (bursts per minute [bursts/minute]) was calculated as the difference in MSNA change from Baseline to after the inhalation of salmeterol (2 hours, Week 0, Visit 1) minus the MSNA change from Baseline to after the inhalation of placebo (1 hour, Week 0, Visit 1).
Time Frame Baseline and 2 hours (Week 0)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-MSNA Population
Arm/Group Title Salmeterol 50 µg BID
Hide Arm/Group Description:
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: Bursts/minute
0.3  (5.60)
4.Secondary Outcome
Title Change From Baseline in MSNA (Evaluated by Microneurography as Bursts/Minute) at Week 4
Hide Description Human MSNA is composed of vasoconstrictor impulses grouped in pulse synchronous bursts that usually occur in sequences, preferentially during transient reductions of blood pressure. Sympathetic activity was measured using microneurographic recordings of efferent in the peroneal nerve. MSNA reflects sympathetic discharge to the vascular bed of the skeletal muscle. Change in MSNA is expressed in terms of bursts per minute (bursts/minute). Change from Baseline was calculated as the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).
Time Frame Baseline and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-MSNA Population. Only those participants available at the indicated time points were assessed.
Arm/Group Title Salmeterol 50 µg BID
Hide Arm/Group Description:
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
Overall Number of Participants Analyzed 12
Mean (Standard Deviation)
Unit of Measure: Bursts/minute
0.5  (7.58)
5.Secondary Outcome
Title Change From Baseline in Heart Rate Variability (HRV): Standard Deviation of NN Intervals (SDNN) at 2 Hours (Week 0) and at Week 4 (ITT Population)
Hide Description Heart rate variability (HRV) refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. SDNN reflects all the cyclic components responsible for variability in the period of recording; therefore, it represents total variability. Change in HRV (SDNN) after salmeterol inhalation is expressed in terms of milliseconds (ms). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).
Time Frame Baseline, 2 hours (Week 0), and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the indicated time points were assessed.
Arm/Group Title Salmeterol 50 µg BID
Hide Arm/Group Description:
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
Overall Number of Participants Analyzed 32
Mean (Standard Deviation)
Unit of Measure: ms
Change from Baseline to 2 hours, Week 0, n=32 -1.7  (26.4)
Change from Baseline to Week 4, n=31 0.1  (53.9)
6.Secondary Outcome
Title Change From Baseline in Heart Rate Variability (HRV): Standard Deviation of NN Intervals (SDNN) at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population)
Hide Description HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. SDNN reflects all the cyclic components responsible for variability in the period of recording; therefore, it represents total variability. Change in HRV (SDNN) after salmeterol inhalation is expressed in terms of milliseconds (ms). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).
Time Frame Baseline, 2 hours (Week 0), and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-MSNA Population
Arm/Group Title Salmeterol 50 µg BID
Hide Arm/Group Description:
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: ms
Change from Baseline to 2 hours, Week 0 1.2  (22.5)
Change from Baseline to Week 4 -12.1  (29.5)
7.Secondary Outcome
Title Change From Baseline in Heart Rate Variability (HRV): Square Root of the Mean Squared Difference of Successive NNs (RMSSD) at 2 Hours (Week 0) and at Week 4 (ITT Population)
Hide Description HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. Compared with SDNN, RMSSD is a short-term variation of heart rate. Change in HRV (RMSSD) after salmeterol inhalation is expressed in terms of milliseconds (ms). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).
Time Frame Baseline, 2 hours (Week 0), and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the indicated time points were assessed.
Arm/Group Title Salmeterol 50 µg BID
Hide Arm/Group Description:
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
Overall Number of Participants Analyzed 32
Mean (Standard Deviation)
Unit of Measure: ms
Change from Baseline to 2 hours, Week 0, n=32 -11.5  (36.3)
Change from Baseline to Week 4, n=31 -5.2  (96.1)
8.Secondary Outcome
Title Change From Baseline in Heart Rate Variability (HRV): Square Root of the Mean Squared Difference of Successive NNs (RMSSD) at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population)
Hide Description HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. Compared with SDNN, RMSSD is a short-term variation of heart rate. Change in HRV (RMSSD) after salmeterol inhalation is expressed in terms of milliseconds (ms). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).
Time Frame Baseline, 2 hours (Week 0), and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-MSNA Population
Arm/Group Title Salmeterol 50 µg BID
Hide Arm/Group Description:
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: ms
Change from Baseline to 2 hours, Week 0 -10.6  (26.4)
Change from Baseline to Week 4 -32.5  (47.4)
9.Secondary Outcome
Title Change From Baseline in Heart Rate Variability (HRV): Absolute Low Frequency (LF) Power at 2 Hours (Week 0) and at Week 4 (ITT Population)
Hide Description HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: the LF component of the HRV spectrum reflects sympathetic activity. Change in HRV (absolute LF) after salmeterol inhalation is expressed in terms of milliseconds squared (ms^2). Change from Baseline were calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).
Time Frame Baseline, 2 hours (Week 0), and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the indicated time points were assessed.
Arm/Group Title Salmeterol 50 µg BID
Hide Arm/Group Description:
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
Overall Number of Participants Analyzed 32
Mean (Standard Deviation)
Unit of Measure: ms^2
Change from Baseline to 2 hours, Week 0, n=32 -123.8  (1588.4)
Change from Baseline to Week 4, n=31 -390.1  (1463.3)
10.Secondary Outcome
Title Change From Baseline in Heart Rate Variability (HRV): Absolute Low Frequency (LF) Power at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population)
Hide Description HRV refers to the complex beat-to-beat (N-N) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: The LF component of the HRV spectrum reflects sympathetic activity. Change in HRV (absolute LF) after salmeterol inhalation is expressed in terms of milliseconds squared (ms2). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation), respectively.
Time Frame Baseline, 2 hours (Week 0), and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-MSNA Population
Arm/Group Title Salmeterol 50 µg BID
Hide Arm/Group Description:
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: ms^2
Change from Baseline to 2 hours, Week 0 220.7  (1038.2)
Change from Baseline to Week 4 -248.1  (755.2)
11.Secondary Outcome
Title Change From Baseline in Heart Rate Variability (HRV): Absolute High Frequency (HF) Power at 2 Hours (Week 0) and at Week 4 (ITT Population)
Hide Description HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: the HF component of the HRV spectrum reflects parasympathetic activity. Change in HRV (absolute HF) after salmeterol inhalation is expressed in terms of milliseconds squared (ms^2). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).
Time Frame Baseline, 2 hours (Week 0), and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the indicated time points were assessed.
Arm/Group Title Salmeterol 50 µg BID
Hide Arm/Group Description:
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
Overall Number of Participants Analyzed 32
Mean (Standard Deviation)
Unit of Measure: ms^2
Change from Baseline to 2 hours, Week 0, n=32 -457.9  (1591.6)
Change from Baseline to Week 4, n=31 817.5  (8754.6)
12.Secondary Outcome
Title Change From Baseline in Heart Rate Variability (HRV): Absolute High Frequency (HF) Power at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population)
Hide Description HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: the HF component of the HRV spectrum reflects parasympathetic activity. Change in HRV (absolute HF) after salmeterol inhalation is expressed in terms of milliseconds squared (ms^2). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).
Time Frame Baseline, 2 hours (Week 0), and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-MSNA Population
Arm/Group Title Salmeterol 50 µg BID
Hide Arm/Group Description:
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: ms^2
Change from Baseline to 2 hours, Week 0 -372.1  (1194.4)
Change from Baseline to Week 4 -840.2  (1491.5)
13.Secondary Outcome
Title Change From Baseline in Heart Rate Variability (HRV): Normalized Low Frequency (LF) Power at 2 Hours (Week 0) and at Week 4 (ITT Population)
Hide Description HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: the LF component of the HRV spectrum reflects sympathetic activity. Change in HRV (normalized LF) after salmeterol inhalation is expressed in terms of normalized units that represent the relative value of LF power component in proportion to the total power minus the very LF (VLF) component (LF/(Total Power–VLF)*100). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).
Time Frame Baseline, 2 hours (Week 0), and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the indicated time points were assessed.
Arm/Group Title Salmeterol 50 µg BID
Hide Arm/Group Description:
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
Overall Number of Participants Analyzed 32
Mean (Standard Deviation)
Unit of Measure: percent change
Change from Baseline to 2 hours, Week 0, n=32 8.4  (14.5)
Change from Baseline to Week 4, n=31 2.5  (23.3)
14.Secondary Outcome
Title Change From Baseline in Heart Rate Variability (HRV): Normalized Low Frequency (LF) Power at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population)
Hide Description HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: The LF component of the HRV spectrum reflects sympathetic activity. Change in HRV (normalized LF) after salmeterol inhalation is expressed in terms of normalized units that represent the relative value of LF power component in proportion to the total power minus the very LF (VLF) component (LF/(Total Power–VLF)*100). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).
Time Frame Baseline, 2 hours (Week 0), and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-MSNA Population
Arm/Group Title Salmeterol 50 µg BID
Hide Arm/Group Description:
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: percent change
Change from Baseline to 2 hours, Week 0 10.8  (14.6)
Change from Baseline to Week 4 11.6  (19.0)
15.Secondary Outcome
Title Change From Baseline in Heart Rate Variability (HRV): Normalized High Frequency (HF) Power at 2 Hours (Week 0) and at Week 4 (ITT Population)
Hide Description HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: the HF component of the HRV spectrum reflects parasympathetic activity. Change in HRV (normalized HF) after salmeterol inhalation is expressed in terms of normalized units that represent the relative value of HF power component in proportion to the total power minus the very LF (VLF) component (HF/(Total Power–VLF)*100). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).
Time Frame Baseline, 2 hours (Week 0), and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the indicated time points were assessed.
Arm/Group Title Salmeterol 50 µg BID
Hide Arm/Group Description:
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
Overall Number of Participants Analyzed 32
Mean (Standard Deviation)
Unit of Measure: percent change
Change from Baseline to 2 hours, Week 0, n=32 -8.4  (14.5)
Change from Baseline to Week 4, n=31 -2.5  (23.3)
16.Secondary Outcome
Title Change From Baseline in Heart Rate Variability (HRV): Normalized High Frequency Power (HF) at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population)
Hide Description HRV refers to the complex beat-to-beat (NN) variation in heart rate produced by the interplay of sympathetic and parasympathetic neural activity at the sinus node of the heart. HRV frequencies can be analyzed with frequency domain methods: the HF component of the HRV spectrum reflects parasympathetic activity. Change in HRV (normalized HF) after salmeterol inhalation is expressed in terms of normalized units that represent the relative value of HF power component in proportion to the total power minus the very LF (VLF) component (HF/(Total Power–VLF)*100). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).
Time Frame Baseline, 2 hours (Week 0), and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-MSNA Population
Arm/Group Title Salmeterol 50 µg BID
Hide Arm/Group Description:
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: percent change
Change from Baseline to 2 hours, Week 0 -10.8  (14.6)
Change from Baseline to Week 4 -11.6  (19.0)
17.Secondary Outcome
Title Change From Baseline in Heart Rate Variability (HRV): Heart Rate at 2 Hours (Week 0) and at Week 4 (ITT Population)
Hide Description Heart rate refers to the speed of the heartbeat, specifically the number of heartbeats per unit of time. Change in HRV (heart rate) after salmeterol inhalation is expressed in terms of the heart rate (beats) per minute (heart rate/min). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0 before any inhalation).
Time Frame Baseline, 2 hours (Week 0), and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the indicated time points were assessed.
Arm/Group Title Salmeterol 50 µg BID
Hide Arm/Group Description:
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
Overall Number of Participants Analyzed 32
Mean (Standard Deviation)
Unit of Measure: beats per minute (bpm)
Change from Baseline to 2 hours, Week 0, n=32 3.7  (4.2)
Change from Baseline to Week 4, n=31 3.9  (4.3)
18.Secondary Outcome
Title Change From Baseline in Heart Rate Variability (HRV): Heart Rate at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population)
Hide Description Heart rate refers to the speed of the heartbeat, specifically the number of heartbeats per unit of time. Change in HRV (heart rate) after salmeterol inhalation is expressed in terms of the heart rate (beats) per minute (heart rate/min). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0 before any inhalation).
Time Frame Baseline, 2 hours (Week 0), and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-MSNA Population
Arm/Group Title Salmeterol 50 µg BID
Hide Arm/Group Description:
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: beats per minute (bpm)
Change from Baseline to 2 hours, Week 0 4.4  (4.7)
Change from Baseline to Week 4 4.9  (4.8)
19.Secondary Outcome
Title Change From Baseline in Spontaneous Baroreflex Sensitivity (BRS) at 2 Hours (Week 0) and at Week 4 (ITT Population)
Hide Description BRS is an important characteristic of baroreflex control and is often noninvasively assessed by relating heart rate (HR) fluctuations to blood pressure (BP) fluctuations. Change in BRS after salmeterol inhalation is expressed in terms of milliseconds per millimeters of mercury (ms/mmHg). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0 before any inhalation).
Time Frame Baseline, 2 hours (Week 0), and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were assessed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
Arm/Group Title Salmeterol 50 µg BID
Hide Arm/Group Description:
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
Overall Number of Participants Analyzed 32
Mean (Standard Deviation)
Unit of Measure: ms/mmHg
Change from Baseline to 2 hours, Week 0, n=31 0.1  (1.9)
Change from Baseline to Week 4, n=29 0.2  (2.6)
20.Secondary Outcome
Title Change From Baseline in Spontaneous Baroreflex Sensitivity (BRS) at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population)
Hide Description BRS is an important characteristic of baroreflex control and is often noninvasively assessed by relating heart rate (HR) fluctuations to blood pressure (BP) fluctuations. Change in BRS after salmeterol inhalation is expressed in terms of milliseconds per millimeters of mercury (ms/mmHg). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0 before any inhalation).
Time Frame Baseline, 2 hours (Week 0), and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-MSNA Population. Only those participants available at the indicated time points were assessed.
Arm/Group Title Salmeterol 50 µg BID
Hide Arm/Group Description:
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
Overall Number of Participants Analyzed 17
Mean (Standard Deviation)
Unit of Measure: ms/mmHg
Change from Baseline to 2 hours, Week 0 0.28  (2.2)
Change from Baseline to Week 4 0.44  (3.2)
21.Secondary Outcome
Title Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at 2 Hours (Week 0) and at Week 4 (ITT Population)
Hide Description Pulmonary function was measured by FEV1, defined as the volume of air that which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change in FEV1 after salmeterol inhalation is expressed in terms of liters (L). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).
Time Frame Baseline, 2 hours (Week 0), and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the indicated time points were assessed.
Arm/Group Title Salmeterol 50 µg BID
Hide Arm/Group Description:
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
Overall Number of Participants Analyzed 32
Mean (Standard Deviation)
Unit of Measure: L
Change from Baseline to 2 hours, Week 0, n=32 -0.04  (0.23)
Change from Baseline to Week 4, n=31 -0.04  (0.21)
22.Secondary Outcome
Title Change From Baseline in Forced Expiratory Volume in One Second (FEV1) at 2 Hours (Week 0) and at Week 4 (ITT-MSNA Population)
Hide Description Pulmonary function was measured by FEV1, defined as the volume of air that which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change in FEV1 after salmeterol inhalation is expressed in terms of liters (L). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).
Time Frame Baseline, 2 hours (Week 0), and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT-MSNA Population. Only those participants available at the indicated time points were assessed.
Arm/Group Title Salmeterol 50 µg BID
Hide Arm/Group Description:
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
Overall Number of Participants Analyzed 18
Mean (Standard Deviation)
Unit of Measure: L
Change from Baseline to 2 hours, Week 0 -0.05  (0.26)
Change from Baseline to Week 4 -0.08  (0.21)
23.Secondary Outcome
Title Change From Baseline in Systolic and Diastolic Blood Pressure (BP) at 2 Hours (Week 0) and at Week 4
Hide Description Systolic and diastolic BP was manually measured. Change in BP after salmeterol inhalation is expressed in terms of millimeters of mercury (mmHg). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).
Time Frame Baseline, 2 hours (Week 0), and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the indicated time points were assessed.
Arm/Group Title Salmeterol 50 µg BID
Hide Arm/Group Description:
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: mmHg
Systolic: Change from Baseline to 2 hours, Week 0 3.6  (12.3)
Systolic: Change from Baseline to Week 4 3.7  (15.7)
Diastolic: Change from Baseline to 2 hours, Week 0 1.9  (6.7)
Diastolic: Change from Baseline to Week 4 0.7  (6.8)
24.Secondary Outcome
Title Change From Baseline in Respiratory Rate at 2 Hours (Week 0) and at Week 4
Hide Description Respiratory rate is defined as the number of breaths taken within a set amount of time (typically within 60 seconds). Change in respiratory rate after salmeterol inhalation is expressed in terms of respiratory rate (breaths) per minute (min). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).
Time Frame Baseline, 2 hours (Week 0), and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the indicated time points were assessed.
Arm/Group Title Salmeterol 50 µg BID
Hide Arm/Group Description:
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
Overall Number of Participants Analyzed 32
Mean (Standard Deviation)
Unit of Measure: breaths per minute
Change from Baseline to 2 hours, Week 0, n=32 -0.5  (1.6)
Change from Baseline to Week 4, n=31 -0.1  (2.6)
25.Secondary Outcome
Title Change From Baseline in Tidal Volume at 2 Hours (Week 0) and at Week 4
Hide Description Tidal volume is defined as the lung volume representing the normal volume of air displaced between normal inspiration and expiration when extra effort is not applied (normal value is approximately 500 milliliters or 7 milliliters per kilogram of body weight). Change in tidal volume after salmeterol inhalation is expressed in terms of milliliters (mL). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).
Time Frame Baseline, 2 hours (Week 0), and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were assessed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
Arm/Group Title Salmeterol 50 µg BID
Hide Arm/Group Description:
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
Overall Number of Participants Analyzed 32
Mean (Standard Deviation)
Unit of Measure: mL
Change from Baseline to 2 hours, Week 0, n=30 60.4  (118.0)
Change from Baseline to Week 4, n=24 55.6  (183.7)
26.Secondary Outcome
Title Change From Baseline in Respiratory Minute Volume at 2 Hours (Week 0) and at Week 4
Hide Description Respiratory minute volume is defined as the volume of gas inhaled (inhaled minute volume) or exhaled (exhaled minute volume) from a person's lungs per minute. Change in respiratory minute volume after salmeterol inhalation is expressed in terms of milliliters per minute (mL/min). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).
Time Frame Baseline, 2 hours (Week 0), and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were assessed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
Arm/Group Title Salmeterol 50 µg BID
Hide Arm/Group Description:
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
Overall Number of Participants Analyzed 32
Mean (Standard Deviation)
Unit of Measure: mL/min
Change from Baseline to 2 hours, Week 0, n=30 572.0  (1529.7)
Change from Baseline to Week 4, n=24 671.4  (2963.3)
27.Secondary Outcome
Title Change From Baseline in Catecholamines (Plasma Norepinephrine) at 2 Hours (Week 0) and at Week 4
Hide Description Catecholamines are important neurotransmitters in the central nervous system and play a crucial role in the autonomic regulation of many homeostatic functions. Change in catecholamines (plasma norepinephrine) after salmeterol inhalation is expressed in terms of nanogramms per liter (ng/L). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).
Time Frame Baseline, 2 hours (Week 0), and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were assessed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
Arm/Group Title Salmeterol 50 µg BID
Hide Arm/Group Description:
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
Overall Number of Participants Analyzed 32
Mean (Standard Deviation)
Unit of Measure: ng/L
Change from Baseline to 2 hours, Week 0, n=26 -42.4  (103)
Change from Baseline to Week 4, n=29 -5.7  (133)
28.Secondary Outcome
Title Change From Baseline in Catecholamines (Plasma Epinephrine) at 2 Hours (Week 0) and at Week 4
Hide Description Catecholamines are important neurotransmitters in the central nervous system and play a crucial role in the autonomic regulation of many homeostatic functions. Change in catecholamines (plasma epinephrine) after salmeterol inhalation is expressed in terms of nanograms per milliliter (ng/mL). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).
Time Frame Baseline, 2 hours (Week 0), and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were assessed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
Arm/Group Title Salmeterol 50 µg BID
Hide Arm/Group Description:
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
Overall Number of Participants Analyzed 32
Mean (Standard Deviation)
Unit of Measure: ng/mL
Change from Baseline to 2 hours, Week 0, n=26 6.7  (12.7)
Change from Baseline to Week 4, n=29 -0.3  (10.4)
29.Secondary Outcome
Title Change From Baseline in Catecholamines (Brain Natriuretic Peptide [BNP]) at 2 Hours (Week 0) and at Week 4
Hide Description Catecholamines are important neurotransmitters in the central nervous system and play a crucial role in the autonomic regulation of many homeostatic functions. Change in catecholamines (BNP) after salmeterol inhalation is expressed in terms of picograms per milliliter (pg/mL). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).
Time Frame Baseline, 2 hours (Week 0), and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the indicated time points were assessed.
Arm/Group Title Salmeterol 50 µg BID
Hide Arm/Group Description:
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
Overall Number of Participants Analyzed 27
Mean (Standard Deviation)
Unit of Measure: pg/mL
Change from Baseline to 2 hours, Week 0 2.4  (7.0)
Change from Baseline to Week 4 -6.1  (28.5)
30.Secondary Outcome
Title Change From Baseline in Oxygen Saturation Measured Via Pulse Oxymetry (SpO2) at 2 Hours (Week 0) and at Week 4
Hide Description Oxygen saturation measures the capacity of blood to transport oxygen to other parts of the body. Oxygen binds to hemoglobin in red blood cells when moving through the lungs. A pulse oximeter uses two frequencies of light (red and infrared) to determine the percentage of hemoglobin in the blood that is saturated with oxygen. The percentage is called blood oxygen saturation, or SpO2. Change in SpO2 after salmeterol inhalation is expressed in terms of percent. Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).
Time Frame Baseline, 2 hours (Week 0), and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: all participants included in the study who received at least one dose of study medication. Only those participants available at the indicated time points were assessed.
Arm/Group Title Salmeterol 50 µg BID
Hide Arm/Group Description:
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
Overall Number of Participants Analyzed 32
Mean (Standard Deviation)
Unit of Measure: percent
Change from Baseline to 2 hours, Week 0, n=32 -0.2  (1.1)
Change from Baseline to Week 4, n=31 -0.5  (2.0)
31.Secondary Outcome
Title Change From Baseline in Transcutaneous Carbon Dioxide (tCO2) at 2 Hours (Week 0) and at Week 4
Hide Description Transcutaneous carbon dioxide monitoring is a noninvasive way of continuously measuring the tension of these gases in the skin. This methodology provides a continuous noninvasive estimation of the arterial CO2 value. Change in tCO2 after salmeterol inhalation is expressed in terms of millimeters of mercury (mmHg). Change from Baseline was calculated as the value at 2 hours (Week 0 [Visit 1, after salmeterol inhalation]) and the value at Week 4 (Visit 2, after salmeterol inhalation) minus the value at Baseline (Week 0, before any inhalation).
Time Frame Baseline, 2 hours (Week 0), and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population. Only those participants available at the indicated time points were assessed.
Arm/Group Title Salmeterol 50 µg BID
Hide Arm/Group Description:
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
Overall Number of Participants Analyzed 32
Mean (Standard Deviation)
Unit of Measure: mmHg
Change from Baseline to 2 hours, Week 0, n=32 -0.94  (2.19)
Change from Baseline to Week 4, n=31 -0.82  (4.17)
32.Secondary Outcome
Title Lung Function (Forced Vital Capacity [FVC], Functional Residual Capacity [FRC; Body and Helium], Total Lung Capacity [TLC], and Residual Volume [RV]) at Baseline (Week 0) and at Week 4
Hide Description FVC is defined as the volume of air that can be forcibly blown out from the lungs after a full inspiration. FRC is defined as the volume of air present in the lungs, specifically the parenchyma tissues, at the end of a passive expiration. TLC is defined as the maximum volume to which the lungs can be expanded with the greatest possible inspiratory effort; it is equal to VC plus the RV and is approximately 5800 milliliters. RV is defined as the amount of gas remaining in the lungs at the end of a maximal exhalation. All parameters describing lung function are expressed in terms of liters (L). Lung function (FVC, FRC [body and helium], TLC, and RV) was evaluated at Baseline (Week 0, [Visit 1, before any inhalation]) and at Week 4 (Visit 2, after salmeterol inhalation).
Time Frame Baseline and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the indicated time points were assessed.
Arm/Group Title Salmeterol 50 µg BID
Hide Arm/Group Description:
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
Overall Number of Participants Analyzed 32
Mean (Standard Deviation)
Unit of Measure: L
FVC at Baseline, Week 0, n=32 2.60  (0.7)
FVC at Week 4, n=31 2.64  (0.7)
FRC (body) at Baseline, Week 0, n=32 4.65  (1.3)
FRC (body) at Week 4, n=27 3.67  (1.8)
FRC (helium) at Baseline, Week 0, n=24 3.64  (1.0)
FRC (helium) at Week 4, n=24 3.38  (0.8)
TLC at Baseline, Week 0, n=32 6.61  (1.4)
TLC at Week 4, n=27 5.67  (1.8)
RV at Baseline, Week 0, n=32 3.90  (1.3)
RV at Week 4, n=27 2.90  (1.8)
33.Secondary Outcome
Title Number of Participants With Diastolic Dysfunction on Echocardiography at Baseline (Week 0) and at Week 4
Hide Description Diastolic dysfunction refers to the decline in performance of one (usually the left ventricle) or both (left and right) ventricles during diastole. The number of participants with diastolic dysfunction on echocardiography was evaluated at Baseline (Week 0, [Visit 1, before any inhalation]) and at Week 4 (Visit 2, after salmeterol inhalation).
Time Frame Baseline and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the indicated time points were assessed.
Arm/Group Title Salmeterol 50 µg BID
Hide Arm/Group Description:
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
Overall Number of Participants Analyzed 32
Measure Type: Number
Unit of Measure: participants
Baseline: Diastolic dysfunction: Yes, n=32 3
Baseline: Diastolic dysfunction: No, n=32 29
Week 4: Diastolic dysfunction: Yes, n=31 5
Week 4: Diastolic dysfunction: No, n=31 26
34.Secondary Outcome
Title Arterial Stiffness at Baseline (Week 0) and at Week 4
Hide Description Arterial stiffness occurs as a consequence of age and arteriosclerosis. Carotid-femoral pulse wave velocity (PWV), a measure of arterial stiffness, is determined from the time taken for the arterial pulse to propagate from the carotid to the femoral artery. PWV was evaluated in terms of meters per second (m/s). PWV after salmeterol inhalation at Baseline (Week 0, [Visit 1, before any inhalation]) and at Week 4 (Visit 2, after inhalation of salmeterol) was assessed.
Time Frame Baseline and Week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants available at the specified time points were assessed (represented by n=X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
Arm/Group Title Salmeterol 50 µg BID
Hide Arm/Group Description:
Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
Overall Number of Participants Analyzed 32
Mean (Standard Deviation)
Unit of Measure: m/s
PWV at Baseline, Week 0, n=30 9.2  (2.1)
PWV at Week 4, n=29 8.8  (2.2)
Time Frame Serious adverse events (SAEs) and non-serious adverse events (AEs) were collected from the start of the study medication to the end of treatment (up to 37 days/average of 28.2 days)
Adverse Event Reporting Description SAEs and non-serious AEs were reported for members of the Intent-to-Treat (ITT) Population, comprised of all participants randomized to treatment who received at least one dose of trial medication during the treatment period.
 
Arm/Group Title Salmeterol 50 µg BID
Hide Arm/Group Description Participants received salmeterol 50 micrograms (µg) via DISKUS inhaler twice daily (BID) over the course of 4 weeks.
All-Cause Mortality
Salmeterol 50 µg BID
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Salmeterol 50 µg BID
Affected / at Risk (%)
Total   0/32 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Salmeterol 50 µg BID
Affected / at Risk (%)
Total   19/32 (59.38%) 
Cardiac disorders   
Palpitations  1  1/32 (3.13%) 
Gastrointestinal disorders   
Diarrhoea  1  2/32 (6.25%) 
Dry mouth  1  1/32 (3.13%) 
Swollen tongue  1  1/32 (3.13%) 
Vomiting  1  1/32 (3.13%) 
Infections and infestations   
Bronchitis  1  1/32 (3.13%) 
Gingivitis  1  1/32 (3.13%) 
Nasopharyngitis  1  1/32 (3.13%) 
Injury, poisoning and procedural complications   
Arthropod bite  1  1/32 (3.13%) 
Fibula fracture  1  1/32 (3.13%) 
Musculoskeletal and connective tissue disorders   
Muscle spasms  1  1/32 (3.13%) 
Musculoskeletal pain  1  1/32 (3.13%) 
Pain in extremity  1  1/32 (3.13%) 
Nervous system disorders   
Headache  1  2/32 (6.25%) 
Hypoaesthesia  1  2/32 (6.25%) 
Paraesthesia  1  2/32 (6.25%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  1/32 (3.13%) 
Dyspnoea  1  1/32 (3.13%) 
Sputum increased  1  1/32 (3.13%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01536587     History of Changes
Other Study ID Numbers: 114520
First Submitted: February 2, 2012
First Posted: February 22, 2012
Results First Submitted: July 30, 2013
Results First Posted: February 4, 2014
Last Update Posted: April 11, 2014