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Trial record 42 of 318 for:    FLUTICASONE AND SALMETEROL

Fluticasone Propionate/Salmeterol Combination 250/50 DISKUS in the Exercise Endurance Time in Patients With Chronic Obstructive Pulmonary Disease (ESWT)

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ClinicalTrials.gov Identifier: NCT01124422
Recruitment Status : Completed
First Posted : May 17, 2010
Results First Posted : December 21, 2011
Last Update Posted : November 8, 2017
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Pulmonary Disease, Chronic Obstructive
Interventions Drug: fluticasone propionate/salmeterol inhalation powder DISKUS 250/50
Drug: tiotropium bromide inhalation powder HandiHaler
Enrollment 255
Recruitment Details  
Pre-assignment Details In the open-label 4-week run-in phase, participants received 18 micrograms Tiotropium (TIO) once daily. Participants completing this phase (n=255) were then randomized to receive either TIO+placebo or TIO+Fluticasone propionate/salmeterol combination DISKUS. The number enrolled in the protocol section reflects these 255 randomized participants.
Arm/Group Title Tiotropium (TIO) TIO+Placebo TIO+FSC
Hide Arm/Group Description Tiotropium (TIO) was administered in the dose of 18 micrograms (mcg) once daily for a duration of 4 weeks Matching placebo DISKUS twice daily (BD) plus tiotropium 18 mcg once daily for a duration of 4 weeks Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
Period Title: 4-Week Open-label Run-in Phase
Started 338 0 0
Completed 255 0 0
Not Completed 83 0 0
Reason Not Completed
Withdrawal by Subject             5             0             0
Adverse Event             7             0             0
Physician Decision             4             0             0
Lost to Follow-up             1             0             0
Did Not Meet Continuation Criteria             61             0             0
Protocol Violation             5             0             0
Period Title: 4-Week Double-blind Treatment Phase
Started 0 131 124
Completed 0 120 115
Not Completed 0 11 9
Reason Not Completed
Withdrawal by Subject             0             0             3
Adverse Event             0             6             3
Physician Decision             0             5             2
Lost to Follow-up             0             0             1
Arm/Group Title TIO+Placebo TIO+FSC Total
Hide Arm/Group Description Matching placebo DISKUS twice daily (BD) plus tiotropium 18 mcg once daily for a duration of 4 weeks Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks Total of all reporting groups
Overall Number of Baseline Participants 131 124 255
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 131 participants 124 participants 255 participants
62.9  (9.85) 62.5  (8.94) 62.7  (9.41)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 131 participants 124 participants 255 participants
Female
61
  46.6%
54
  43.5%
115
  45.1%
Male
70
  53.4%
70
  56.5%
140
  54.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 131 participants 124 participants 255 participants
African American/African Heritage 4 10 14
Japanese/East Asian Heritage/South East Asian 1 2 3
Native Hawaiian or other Pacific Islander 0 1 1
White 126 110 236
American Indian or Alaska Native and White 0 1 1
1.Primary Outcome
Title Mean Change in Exercise Endurance Time (EET) From Baseline (Week 3) to Week 8
Hide Description EET is defined as the time taken by a participant to exert himself during an exercise. EET was calculated based on the Endurance Shuttle Walk test (ESWT). The ESWT is a standardized, externally controlled, constant-paced field test for the assessment of endurance capacity in participants with chronic lung disease. Change from Baseline in EET was calculated as the value at Week 8 minus the value at Baseline.
Time Frame Baseline (Week 3) and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all participants randomized to study drug. Only those participants contributing data at the indicated time points were analyzed.
Arm/Group Title TIO+Placebo TIO+FSC
Hide Arm/Group Description:
Matching placebo DISKUS twice daily (BD) plus tiotropium 18 mcg once daily for a duration of 4 weeks
Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
Overall Number of Participants Analyzed 122 115
Mean (Standard Error)
Unit of Measure: Seconds (sec)
23.3  (15.5) 6.0  (16.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection TIO+Placebo, TIO+FSC
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.181
Comments ANCOVA model with terms for treatment, investigator, Oxycon stratum, and baseline value
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -27.6
Confidence Interval (2-Sided) 95%
-68.2 to 13.0
Parameter Dispersion
Type: Standard Error of the Mean
Value: 20.58
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Mean Change in Scores on the Exercise Dyspnea Scale (EDS) From Baseline (Week 3) to Week 8
Hide Description EDS is used to measure the level of breathlessness due to exercise, assessed using a 10-point modified Borg scale at 2-minute intervals during the ESWT: 0=no difficulty in breathing at all, 10=maximal breathing difficulty (BD). The participant pointed to the level on the scale correlating with his BD, and the local study coordinator confirmed that level verbally to him. Change from Baseline was calculated as the value at Week 8 minus the value at Baseline. A dyspnea score/time slope was calculated by fitting a linear regression line to the dyspnea scores reported during the exercise tests.
Time Frame Baseline (Week 3) and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants contributing data at the indicated time points were analyzed.
Arm/Group Title TIO+Placebo TIO+FSC
Hide Arm/Group Description:
Matching placebo DISKUS twice daily (BD) plus tiotropium 18 mcg once daily for a duration of 4 weeks
Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
Overall Number of Participants Analyzed 121 110
Mean (Standard Error)
Unit of Measure: Scores on a scale/minute
-0.1  (0.055) -0.06  (0.058)
3.Secondary Outcome
Title Mean Change in EDS at Isotime From Baseline (Week 3) to Week 8
Hide Description EDS at isotime (last common time point for an exercise assessment [i.e., last Borg score time point of the shortest exercise test for each participant]) was assessed using a 10-point modified Borg scale. Change from Baseline in EDS at isotime was calculated as the value at Week 8 minus the value at Baseline.
Time Frame Baseline (Week 3) and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants contributing data at the indicated time points were analyzed.
Arm/Group Title TIO+Placebo TIO+FSC
Hide Arm/Group Description:
Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
Overall Number of Participants Analyzed 121 110
Mean (Standard Error)
Unit of Measure: Scores on a scale
-0.3  (0.2) -0.5  (0.2)
4.Secondary Outcome
Title Mean Change in Pre-dose and Post-dose Resting Inspiratory Capacity (IC) From Baseline (Week 4) to Week 8
Hide Description Resting IC is the volume of gas that can be taken into the lungs in a full inhalation at the resting position. The resting IC was measured before and after dosing. Change from Baseline in pre-dose resting IC was calculated as the pre-dose value at Week 8 minus the pre-dose value at Week 4. Change from Baseline in post-dose resting IC was calculated as the post-dose value at Week 8 minus the pre-dose value at Week 4.
Time Frame Baseline (Week 4) and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants contributing data at the indicated time points were analyzed.
Arm/Group Title TIO+Placebo TIO+FSC
Hide Arm/Group Description:
Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
Overall Number of Participants Analyzed 122 115
Mean (Standard Error)
Unit of Measure: Milliliters (mL)
Pre-dose -29  (29) 60  (31.2)
Post-dose 73  (29.6) 167  (31.4)
5.Secondary Outcome
Title Mean Change in Exercise Inspiratory Capacity (EIC) at the End of Exercise From Baseline (Week 3) to Week 8
Hide Description EIC is the volume of gas that can be taken into the lungs in a full inhalation during exercise. Participants were asked to undergo the IC test every 2 minutes during exercise and at the end of the exercise, to follow changes in operational lung volumes that occured in association with exercise. Change from Baseline in EIC was calculated as the value at the end of exercise at Week 8 minus the value at the end of exercise at Baseline.
Time Frame Baseline (Week 3) and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants contributing data at the indicated time points were analyzed.
Arm/Group Title TIO+Placebo TIO+FSC
Hide Arm/Group Description:
Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
Overall Number of Participants Analyzed 38 29
Mean (Standard Error)
Unit of Measure: mL
-7.4  (120) 46.6  (93.3)
6.Secondary Outcome
Title Mean Change in Flow of Oxygen (V'O2) Per Time Slope During the Course of the ESWT From Baseline (Week 3) to Week 8
Hide Description The V'O2 was measured during the ESWT using the Oxycon Mobile System (OMS), a portable telemetric monitoring system consisting of an oxygen sensor allowing for breath-by-breath measurement of gas exchange parameters in the lungs. The V'O2 was collected in units of mL and then regressed over the conduct of the exercise test measured in minutes. The V'O2 per time slope was calculated for each participant (par.) by fitting a linear regression line to the V'O2 recorded for each par. during the ESWT. V'O2 per time slope results were compared between treatment groups as means of these regression lin
Time Frame Baseline (Week 3) and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants contributing data at the indicated time points were analyzed.
Arm/Group Title TIO+Placebo TIO+FSC
Hide Arm/Group Description:
Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
Overall Number of Participants Analyzed 41 32
Mean (Standard Error)
Unit of Measure: mL/minute (min)
-13.3  (10.36) -6.1  (14.89)
7.Secondary Outcome
Title Mean Change in Flow of Carbon Dioxide (V'CO2) Per Time Slope During the Course of the ESWT From Baseline (Week 3) to Week 8
Hide Description The amount of CO2 in the hemoglobin of the participants was measured during the ESWT using the OMS. The system consisted of a carbon dioxide sensor and allowed breath-by-breath measurement of pulmonary gas exchange parameters. The V'CO2 per time slope was calculated for each participant by fitting a linear regression line to the V'CO2 recorded for each participant during the ESWT. V'CO2 per time slope results were compared between treatment groups as means of these regression lines. Change from Baseline in V'CO2 per time slope was calculated as the value at Week 8 minus the value at Baseline.
Time Frame Baseline (Week 3) and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants contributing data at the indicated time points were analyzed.
Arm/Group Title TIO+Placebo TIO+FSC
Hide Arm/Group Description:
Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
Overall Number of Participants Analyzed 41 31
Mean (Standard Error)
Unit of Measure: mL/min
-17.4  (10.36) -0.7  (11.96)
8.Secondary Outcome
Title Mean Change in Minute Ventilation (V'E) Per Time Slope During the Course of the ESWT From Baseline (Week 3) to Week 8
Hide Description The V'E was measured in the participants during the ESWT using the OMS. The system consisted of a volume transducer, oxygen sensor, and carbon dioxide sensor and allowed breath-by-breath measurement of pulmonary gas exchange parameters. The V'E was collected in liters and then regressed over the conduct of the exercise test measured in minutes. The V'E per time slope was calculated for each participant by fitting a linear regression line to the V'E recorded for each participant during the ESWT. V'E per time slope results were compared between treatment groups as means of the regression lines.
Time Frame Baseline (Week 3) and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants contributing data at the indicated time points were analyzed.
Arm/Group Title TIO+Placebo TIO+FSC
Hide Arm/Group Description:
Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
Overall Number of Participants Analyzed 42 34
Mean (Standard Error)
Unit of Measure: Liter (L)/min
-0.7  (0.35) -0.2  (0.49)
9.Secondary Outcome
Title Mean Change in Heart Rate (HR) Per Time Slope During the Course of the ESWT From Baseline (Week 3) to Week 8
Hide Description HR is defined as the number of heartbeats per unit of time, typically expressed as beats per minute (bpm). It was measured during the ESWT using the OMS. The HR was collected in units of bpm and then regressed over the conduct of the exercise test measured in minutes. The HR per time slope was calculated for each participant by fitting a linear regression line to the HR recorded for each participant during the exercise test. HR per time slope results were compared between treatment groups as means of these regression lines.
Time Frame Baseline (Week 3) and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants contributing data at the indicated time points were analyzed.
Arm/Group Title TIO+Placebo TIO+FSC
Hide Arm/Group Description:
Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
Overall Number of Participants Analyzed 42 34
Mean (Standard Error)
Unit of Measure: bpm/min
-1.1  (0.70) 0.7  (0.80)
10.Secondary Outcome
Title Mean Change in Respiratory Exchange Ratio (RER) Per Time Slope During the Course of the ESWT From Baseline to Week 8
Hide Description The respiratory exchange ratio was calculated as the ratio of VCO2 and VO2. The ratio of the amount of carbon dioxide and oxygen in the hemoglobin of the participants was measured during the ESWT using the OMS. The system consisted of oxygen and carbon dioxide sensors and allowed breath-by-breath measurement of pulmonary gas exchange parameters. Change from Baseline in RER was calculated as the value at Week 8 minus the value at Baseline.
Time Frame Baseline (Week 3) and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants contributing data at the indicated time points were analyzed.
Arm/Group Title TIO+Placebo TIO+FSC
Hide Arm/Group Description:
Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
Overall Number of Participants Analyzed 42 34
Mean (Standard Error)
Unit of Measure: Ratio of VCO2 and VO2
-0.01  (0.004) 0.01  (0.007)
11.Secondary Outcome
Title Mean Change in Respiratory Rate (RR) Per Time Slope During the Course of the ESWT From Baseline (Week 3) to Week 8
Hide Description RR is defined as the number of breaths taken within a set amount of time (typically within 60 secs). The RR of the participants was measured during the ESWT using the OMS. The system consisted of volume transducer oxygen and carbon dioxide sensors and allowed breath-by-breath measurement of pulmonary gas exchange parameters. The RR per time slope was calculated for each participant by fitting a linear regression line to the RR recorded for each participant during the ESWT. RR per time slope results were compared between treatment groups as means of these regression lines.
Time Frame Baseline (Week 3) and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants contributing data at the indicated time points were analyzed.
Arm/Group Title TIO+Placebo TIO+FSC
Hide Arm/Group Description:
Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
Overall Number of Participants Analyzed 42 34
Mean (Standard Error)
Unit of Measure: breaths/min/min
-0.1  (0.18) -0.5  (0.44)
12.Secondary Outcome
Title Mean Change in Respiratory Rate (RR) at Isotime During the Course of the ESWT From Baseline to Week 8
Hide Description RR is defined as the number of breaths taken within a set amount of time (typically within 60 secs). The RR of the participants at isotime was measured during the ESWT using the OMS. Change from Baseline in RR at isotime was calculated as the value at Week 8 minus the value at Baseline.
Time Frame Baseline (Week 3) and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants contributing data at the indicated time points were analyzed.
Arm/Group Title TIO+Placebo TIO+FSC
Hide Arm/Group Description:
Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
Overall Number of Participants Analyzed 42 34
Mean (Standard Error)
Unit of Measure: breaths/min
0.8  (0.71) -0.5  (0.68)
13.Secondary Outcome
Title Mean Change in Tidal Volume (VT) Per Time Slope During the Course of the ESWT From Baseline to Week 8
Hide Description VT is 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 mL or 7 mL/kg body weight). VT was measured during the ESWT using the OMS, consisting of volume transducer O2 and CO2 sensors and allowing breath-by-breath measurement of pulmonary gas exchange parameters. The participant's VT per time slope was calculated by fitting a linear regression line (RL) to their VT during the ESWT. VT per time slope results were compared between treatment groups as means of these RLs.
Time Frame Baseline (Week 3) and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants contributing data at the indicated time points were analyzed.
Arm/Group Title TIO+Placebo TIO+FSC
Hide Arm/Group Description:
Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
Overall Number of Participants Analyzed 42 34
Mean (Standard Error)
Unit of Measure: L/min
-0.02  (0.008) 0  (0.014)
14.Secondary Outcome
Title Mean Change in Tidal Volume (VT) at Isotime During the Course of the ESWT From Baseline to Week 8
Hide Description VT is defined as the lung volume representing the normal volume of air displaced between normal inspiration and expiration when extra effort is not applied. The normal value is approximately 500 mL or 7 mL/kg body weight. The VT of the participants at isotime was measured during the ESWT using the OMS. Change from Baseline in VT at isotime was calculated as the value at Week 8 minus the value at Baseline.
Time Frame Baseline (Week 3) and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants contributing data at the indicated time points were analyzed.
Arm/Group Title TIO+Placebo TIO+FSC
Hide Arm/Group Description:
Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
Overall Number of Participants Analyzed 42 34
Mean (Standard Error)
Unit of Measure: L
-0.10  (0.04) 0.08  (0.042)
15.Secondary Outcome
Title Mean Change in HR Per Time Slope During the Course of the ESWT Using Pulse Oximetry From Baseline to Week 8 (Non-OMS Subgroup)
Hide Description HR was measured during the course of the ESWT in the non-OMS subgroup using pulse oximetry. The HR per time slope was calculated for each participant by fitting a linear regression line to the HR recorded for each participant during the ESWT. HR per time slope results were compared between treatment groups as means of these regression lines. Change from Baseline in HR was calculated as the value at Week 8 minus the value at Baseline.
Time Frame Baseline (Week 3) and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants contributing data at the indicated time points were analyzed. A subgroup of participants specified sites provided cardio-respiratory and exercise IC measurements with the Oxycon Mobile System (OMS). Participants not at these sites formed the non-OMS subgroup.
Arm/Group Title TIO+Placebo TIO+FSC
Hide Arm/Group Description:
Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
Overall Number of Participants Analyzed 72 76
Mean (Standard Error)
Unit of Measure: bpm/min
-0.8  (0.55) -0.6  (0.56)
16.Secondary Outcome
Title Mean Change in Ratio of Respiratory Rate (RR) to Tidal Volume (VT) or RR/VT at Isotime During the Course of the ESWT From Baseline to Week 8
Hide Description The RR and VT of the participants at isotime were measured during the ESWT using the OMS. The ratio of RR per VT (value of RR divided by value of VT) at isotime was calculated. Change from Baseline in RR/VT at isotime was calculated as the value at Week 8 minus the value at Baseline.
Time Frame Baseline (Week 3) and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants contributing data at the indicated time points were analyzed.
Arm/Group Title TIO+Placebo TIO+FSC
Hide Arm/Group Description:
Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
Overall Number of Participants Analyzed 42 34
Mean (Standard Error)
Unit of Measure: breaths/min/L
2.7  (1.14) -2.5  (1.27)
17.Secondary Outcome
Title Mean Change in EIC at 2 to 3.5 Minutes During the Exercise Period From Baseline (Week 3) to Week 8
Hide Description The EIC was measured at 2 to 3.5 minutes during the exercise period. Change from Baseline in EIC was calculated as the value at Week 8 minus the value at Baseline.
Time Frame Baseline (Week 3) and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants contributing data at the indicated time points were analyzed.
Arm/Group Title TIO+Placebo TIO+FSC
Hide Arm/Group Description:
Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
Overall Number of Participants Analyzed 24 22
Mean (Standard Error)
Unit of Measure: mL
-148.3  (118.7) 200  (110.2)
18.Secondary Outcome
Title Mean Change in Scores on the Chronic Respiratory Disease Questionnaire Self-Administered Standardized (CRQ-SAS) Questionnaire From Week 4 to Week 8
Hide Description The CRQ-SAS, a self-administered tool used to assess health-related quality-of-life (HRQOL), consists of 20 questions (q.) in 4 domains: Dyspnea (5 q.), Fatigue (4 q.), Emotional Function (7 q.), and Mastery (4 q.). Participants rated their experience on a 7-point scale in response to each q.: 1 (maximum impairment) to 7 (no impairment); higher scores indicate better HRQOL. Individual q. were equally weighted, and domain scores (range=1-7) were calculated as the mean across the non-missing items within each domain (domain scores were calculated although an individual item score was missing).
Time Frame Week 4 and Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants contributing data at the indicated time points were analyzed.
Arm/Group Title TIO+Placebo TIO+FSC
Hide Arm/Group Description:
Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
Overall Number of Participants Analyzed 122 115
Mean (Standard Error)
Unit of Measure: Scores on a scale
Mastery Score 0.07  (0.08) 0.09  (0.1)
Fatigue Score 0.11  (0.08) 0.26  (0.1)
Emotional Function Score 0.10  (0.07) 0.13  (0.08)
Dyspnea Score 0.21  (0.09) 0.32  (0.1)
19.Secondary Outcome
Title Baseline Dyspnea Index (BDI) at Week 4 and Transition Dyspnea Index (TDI) at Week 8
Hide Description The BDI-TDI is a multidimensional dyspnea measurement. The BDI, administered at Week 4, consisted of 3 items (functional impairment, magnitude of task in exertional capacity, and magnitude of effort) requiring recall over the previous 4 weeks. BDI scores ranged from 0 (very severe impairment) to 4 (no impairment); the summed total score = 0 to 12. The TDI, administered at Week 8 as a follow-up of the BDI, consisted of the same 3 items requiring recall over the previous 4 weeks. TDI scores ranged from -3 (major deterioration) to +3 (major improvement); the summed total score = -9 to 9.
Time Frame BDI: Week 4; TDI: Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population. Only those participants contributing data at the indicated time points were analyzed.
Arm/Group Title TIO+Placebo TIO+FSC
Hide Arm/Group Description:
Matching placebo DISKUS BD plus tiotropium 18 mcg once daily for a duration of 4 weeks
Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
Overall Number of Participants Analyzed 130 122
Mean (Standard Error)
Unit of Measure: Scores on a scale
BDI; n=130; 122 6.7  (0.20) 6.9  (0.22)
TDI; n=121, 115 1.1  (0.2) 1.4  (0.2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title TIO+Placebo TIO+FSC
Hide Arm/Group Description Matching placebo DISKUS twice daily (BD) plus tiotropium 18 mcg once daily for a duration of 4 weeks Fluticasone propionate/salmeterol combination (FSC) DISKUS, administered in the dose of 250/50 mcg BD, plus tiotropium in the dose of 18 mcg once daily for a duration of 4 weeks
All-Cause Mortality
TIO+Placebo TIO+FSC
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
TIO+Placebo TIO+FSC
Affected / at Risk (%) Affected / at Risk (%)
Total   3/131 (2.29%)   0/124 (0.00%) 
Cardiac disorders     
Acute myocardial infarction  1  1/131 (0.76%)  0/124 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  2/131 (1.53%)  0/124 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
TIO+Placebo TIO+FSC
Affected / at Risk (%) Affected / at Risk (%)
Total   18/131 (13.74%)   22/124 (17.74%) 
Cardiac disorders     
Arrhythmia  1  0/131 (0.00%)  1/124 (0.81%) 
Coronary artery disease  1  1/131 (0.76%)  0/124 (0.00%) 
Eye disorders     
Conjunctivitis  1  0/131 (0.00%)  1/124 (0.81%) 
Eye pain  1  1/131 (0.76%)  0/124 (0.00%) 
Gastrointestinal disorders     
Dyspepsia  1  0/131 (0.00%)  3/124 (2.42%) 
Dry mouth  1  0/131 (0.00%)  2/124 (1.61%) 
Abdominal pain upper  1  0/131 (0.00%)  1/124 (0.81%) 
Chapped lips  1  1/131 (0.76%)  0/124 (0.00%) 
Diarrhoea  1  1/131 (0.76%)  0/124 (0.00%) 
Gastroesophageal reflux disease  1  1/131 (0.76%)  0/124 (0.00%) 
General disorders     
Chest discomfort  1  1/131 (0.76%)  0/124 (0.00%) 
Infections and infestations     
Nasopharyngitis  1  1/131 (0.76%)  2/124 (1.61%) 
Bronchitis  1  0/131 (0.00%)  2/124 (1.61%) 
Acute sinusitis  1  0/131 (0.00%)  1/124 (0.81%) 
Cellulitis  1  0/131 (0.00%)  1/124 (0.81%) 
Labyrinthitis  1  0/131 (0.00%)  1/124 (0.81%) 
Oral herpes  1  1/131 (0.76%)  0/124 (0.00%) 
Injury, poisoning and procedural complications     
Contusion  1  1/131 (0.76%)  1/124 (0.81%) 
Fall  1  0/131 (0.00%)  1/124 (0.81%) 
Foot fracture  1  1/131 (0.76%)  0/124 (0.00%) 
Joint injury  1  1/131 (0.76%)  0/124 (0.00%) 
Skeletal injury  1  1/131 (0.76%)  0/124 (0.00%) 
Soft tissue injury  1  1/131 (0.76%)  0/124 (0.00%) 
Metabolism and nutrition disorders     
Hyperlipidemia  1  1/131 (0.76%)  0/124 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  2/131 (1.53%)  1/124 (0.81%) 
Muscle spasms  1  0/131 (0.00%)  3/124 (2.42%) 
Back pain  1  1/131 (0.76%)  0/124 (0.00%) 
Musculoskeletal pain  1  1/131 (0.76%)  0/124 (0.00%) 
Myalgia  1  0/131 (0.00%)  1/124 (0.81%) 
Neck pain  1  0/131 (0.00%)  1/124 (0.81%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Squamous cell carcinoma  1  1/131 (0.76%)  0/124 (0.00%) 
Nervous system disorders     
Migraine  1  0/131 (0.00%)  1/124 (0.81%) 
Psychiatric disorders     
Depression  1  0/131 (0.00%)  1/124 (0.81%) 
Insomnia  1  1/131 (0.76%)  0/124 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  3/131 (2.29%)  1/124 (0.81%) 
Cough  1  1/131 (0.76%)  2/124 (1.61%) 
Dsyphonia  1  0/131 (0.00%)  2/124 (1.61%) 
Oropharyngeal pain  1  1/131 (0.76%)  1/124 (0.81%) 
Dyspnoea  1  1/131 (0.76%)  0/124 (0.00%) 
Nasal congestion  1  0/131 (0.00%)  1/124 (0.81%) 
Pulmonary congestion  1  0/131 (0.00%)  1/124 (0.81%) 
Skin and subcutaneous tissue disorders     
Actinic keratosis  1  1/131 (0.76%)  0/124 (0.00%) 
Pruritus  1  0/131 (0.00%)  1/124 (0.81%) 
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
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Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01124422     History of Changes
Other Study ID Numbers: 113877
First Submitted: May 13, 2010
First Posted: May 17, 2010
Results First Submitted: November 17, 2011
Results First Posted: December 21, 2011
Last Update Posted: November 8, 2017