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Trial record 36 of 318 for:    FLUTICASONE AND SALMETEROL

Treatment Of Symptomatic Asthma In Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00197106
Recruitment Status : Completed
First Posted : September 20, 2005
Results First Posted : December 14, 2009
Last Update Posted : March 14, 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 Asthma
Interventions Drug: Salmeterol/ fluticasone propionate Diskus® inhaler 50/100 mcg
Drug: fluticasone propionate 2 x 100 mcg
Enrollment 176
Recruitment Details Participants were eligible to enter the run-in period if they had a documented clinical history of asthma with hyperresponsiveness. Only participants who were symptomatic after this period were eligible to be enrolled into the study and were randomized into either the Salmeterol/Fluticasone propionate (FP) 50/100 mcg plus placebo or FP groups.
Pre-assignment Details 257 participants started the run-in phase of the study, and 99 of these did not meet the inclusion criteria to be entered into the treatment phase. Only baseline characteristics for the 158 participants meeting the inclusion criteria and randomized to either salmeterol/fluticasone propionate 50/100 mcg BID or fluticasone 200 mcg BID are provided.
Arm/Group Title Fluticasone Propionate (FP) 100 mcg Salmeterol/FP 50/100 mcg Plus Placebo FP 200 mcg
Hide Arm/Group Description Fluticasone propionate (FP) 100 mcg (micrograms) twice daily (BID) via DISKUS inhaler One puff Salmeterol/FP 50/100 mcg plus one puff placebo (matching one puff of FP in the 200 mcg group) BID via DISKUS inhaler FP 200 mcg (delivered as two 100 mcg puffs) BID via DISKUS inhaler
Period Title: 4-Week Run-In Period
Started 257 0 0
Completed 158 0 0
Not Completed 99 0 0
Reason Not Completed
Did not meet entry criteria             99             0             0
Period Title: Overall Treatment Period
Started 0 78 80
Completed 0 77 74
Not Completed 0 1 6
Reason Not Completed
Lack of Efficacy             0             1             0
Lost to Follow-up             0             0             2
Protocol Violation             0             0             2
Withdrawal by Subject             0             0             2
Arm/Group Title Salmeterol/FP 50/100 mcg Plus Placebo FP 200 mcg Total
Hide Arm/Group Description Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler FP 200 mcg BID via DISKUS inhaler Total of all reporting groups
Overall Number of Baseline Participants 78 80 158
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 78 participants 80 participants 158 participants
9.4  (1.8) 9.3  (1.9) 9.3  (1.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 78 participants 80 participants 158 participants
Female
36
  46.2%
31
  38.8%
67
  42.4%
Male
42
  53.8%
49
  61.3%
91
  57.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 78 participants 80 participants 158 participants
Caucasian 73 75 148
Mixed 4 3 7
African-American 0 1 1
African 1 1 2
Asthma duration   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 78 participants 80 participants 158 participants
5.7  (3.1) 5.5  (3.0) 5.6  (3.0)
[1]
Measure Description: Mean asthma duration before enrollment in study
1.Primary Outcome
Title Percentage of Symptom-free Days During the Last 10 Weeks of the Treatment Period
Hide Description Asthma symptom-free days are defined as days (24 hour period) with no symptoms, as recorded in the participant’s diary.
Time Frame Last 10 weeks of the treatment period (Weeks 16-26)
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol (PP) population: participants of the Intent-to-Treat (ITT) Population (participants who had taken at least one dose of study medication) who completed the study without any major protocol violations
Arm/Group Title Salmeterol/FP 50/100 mcg Plus Placebo FP 200 mcg
Hide Arm/Group Description:
Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
FP 200 mcg BID via DISKUS inhaler
Overall Number of Participants Analyzed 73 76
Mean (Standard Deviation)
Unit of Measure: percentage of days
50.45  (33.52) 49.75  (35.77)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Salmeterol/FP 50/100 mcg Plus Placebo, FP 200 mcg
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority is considered to be shown if the upper limit of the one-sided 95% confidence interval of the difference uflixotide-useretide does not exceed +15% (uflixotide-useretide represent the mean percentages of asthma symptom-free days of the two respective treatment groups).
Statistical Test of Hypothesis P-Value 0.63
Comments [Not Specified]
Method Repeated Measurements Anal. of Variance
Comments Anal. = Analysis
Method of Estimation Estimation Parameter Adjusted difference
Estimated Value 2.6
Confidence Interval 95%
-8.1 to 13.4
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Percentage of Symptom-free Days During the Entire Treatment Period
Hide Description Asthma symptom-free days are defined as days (24 hour period) with no symptoms, as recorded in the participant’s diary
Time Frame Baseline to Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol (PP) population: participants of the Intent-to-Treat (ITT) Population (participants who had taken at least one dose of study medication) who completed the study without any major protocol violations
Arm/Group Title Salmeterol/FP 50/100 mcg Plus Placebo FP 200 mcg
Hide Arm/Group Description:
Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
FP 200 mcg BID via DISKUS inhaler
Overall Number of Participants Analyzed 73 76
Mean (Standard Deviation)
Unit of Measure: percentage of days
Baseline 22.78  (25.30) 23.06  (25.23)
0-6 weeks 31.58  (31.34) 31.50  (29.73)
6-16 weeks 44.60  (34.67) 45.24  (34.58)
16-26 weeks 50.45  (33.52) 49.75  (35.77)
3.Secondary Outcome
Title Mean Change From Baseline in Percentage Predicted Forced Expiratory Volume in One Second (FEV1) at Week 26
Hide Description Change from Baseline was calculated as the Week 26 value minus the Baseline value. The percentage predicted FEV1 is defined as the volume of air that can be forced out in one second after taking a deep breath and is corrected for the FEV1 value corresponding with the same age.
Time Frame Baseline and Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol (PP) population: participants of the Intent-to-Treat (ITT) Population (participants who had taken at least one dose of study medication) who completed the study without any major protocol violations. At baseline there were 6 missing data and 4 improper testings that could not be used in the analysis.
Arm/Group Title Salmeterol/FP 50/100 mcg Plus Placebo FP 200 mcg
Hide Arm/Group Description:
Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
FP 200 mcg BID via DISKUS inhaler
Overall Number of Participants Analyzed 61 61
Mean (Standard Deviation)
Unit of Measure: percent predicted change
102.5  (14.2) 103.0  (15.3)
4.Secondary Outcome
Title Mean Change From Baseline in Forced Vital Capacity (FVC) at Week 26
Hide Description Change from Baseline was calculated as the Week 26 value minus the Baseline value. Forced vital capacity is defined as the maximum volume of air that can be forcibly expired from the lungs and is calculated by use of spirometry. The spirometry test is performed by using a device called a spirometer, which measures the amount of air one can blow out maximally. Generally, the participant is asked to take the deepest breath they can, and then exhale into the sensor as hard as possible, for as long as possible. The test is normally repeated three times to ensure reproducibility.
Time Frame Baseline and Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol (PP) population: participants of the Intent-to-Treat (ITT) Population (participants who had taken at least one dose of study medication) who completed the study without any major protocol violations. At baseline there were 6 missing data and 4 improper testings that could not be used in the analysis.
Arm/Group Title Salmeterol/FP 50/100 mcg Plus Placebo FP 200 mcg
Hide Arm/Group Description:
Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
FP 200 mcg BID via DISKUS inhaler
Overall Number of Participants Analyzed 61 61
Mean (Standard Deviation)
Unit of Measure: liters
2.28  (0.62) 2.28  (0.59)
5.Secondary Outcome
Title Mean Change From Baseline in Midexpiratory Flow (MEF 50) at Week 26
Hide Description Change from Baseline was calculated as the Week 26 value minus the Baseline value. MEF 50 is defined as maximum expiratory flow rate at 50% of vital capacity. Vital capacity is the maximum amount of air that a person can expel from the lungs after first filling the lungs to their maximum extent. Midexpiratory flow was calculated by use of spirometry. The test is normally repeated at least three times in order to ensure reproducibility.
Time Frame Baseline and Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol (PP) population: participants of the Intent-to-Treat (ITT) Population (participants who had taken at least one dose of study medication) who completed the study without any major protocol violations. For some participants, the data for the MEF 50 measurements are missing, resulting in a smaller number of participants analyzed.
Arm/Group Title Salmeterol/FP 50/100 mcg Plus Placebo FP 200 mcg
Hide Arm/Group Description:
Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
FP 200 mcg BID via DISKUS inhaler
Overall Number of Participants Analyzed 57 57
Mean (Standard Deviation)
Unit of Measure: liters/second
2.28  (0.67) 2.19  (0.72)
6.Secondary Outcome
Title Geometric Means of Nitric Oxide (NO) at Week 26
Hide Description Geometric mean values of NO at week 26 were compared using ANCOVA with adjustment for baseline value of NO, age, gender and center. Analysis of covariance (ANCOVA) is a general linear model with one continuous outcome variable (quantitative) and one or more factor variables.
Time Frame Baseline and Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol (PP) population: participants of the Intent-to-Treat (ITT) Population (participants who had taken at least one dose of study medication) who completed the study without any major protocol violations and completed two NO measurements (Baseline and Week 26)
Arm/Group Title Salmeterol/FP 50/100 mcg Plus Placebo FP 200 mcg
Hide Arm/Group Description:
Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
FP 200 mcg BID via DISKUS inhaler
Overall Number of Participants Analyzed 27 31
Geometric Mean (Full Range)
Unit of Measure: parts per billion
8.6
(1.9 to 64.0)
10.0
(1.8 to 51.6)
7.Secondary Outcome
Title Percent Change From Baseline in RINT Measurements at Week 26
Hide Description Change from Baseline was calculated as the Week 26 value minus the Baseline value. Interrupter respiratory resistance (RINT) measurements were calculated by a combined analysis for relation between change from baseline and occurrence of the endpoint. RINT is a technique that is used for evaluating lung function in poorly collaborating patients (e.g., small children). The measurement is performed during tidal breathing (normal breathing) instead of during maximal expiration, as is done by a spirometry test.
Time Frame Baseline and Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
PP Population: Intent-to-Treat (ITT) Population participants who completed the study without any major protocol violations and completed two NO measurements (Baseline and Week 26). For some participants, the data for the RINT measurement are missing, either at Baseline or at Week 26. As a result, fewer subjects have been included in the analysis.
Arm/Group Title Salmeterol/FP 50/100 mcg Plus Placebo FP 200 mcg
Hide Arm/Group Description:
Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
FP 200 mcg BID via DISKUS inhaler
Overall Number of Participants Analyzed 57 57
Measure Type: Number
Unit of Measure: percent
-9.1 -9.9
8.Secondary Outcome
Title Number of Asthma Exacerbations Per Treatment Group at Week 26
Hide Description An exacerbation is defined as a worsening of the asthma complaints (commonly referred to as an asthma attack) and is reported by the participant experiencing the event. An exacerbation was verified by the use of asthma rescue medication.
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population (participants who had taken at least one dose of study medication)
Arm/Group Title Salmeterol/FP 50/100 mcg Plus Placebo FP 200 mcg
Hide Arm/Group Description:
Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
FP 200 mcg BID via DISKUS inhaler
Overall Number of Participants Analyzed 80 78
Measure Type: Number
Unit of Measure: number of exacerbations
10 7
9.Secondary Outcome
Title Mean Change From Baseline in Provocation Dose (PD20) Causing a 20% Fall in FEV1 at Week 26
Hide Description PD20 was calculated by using increasing dosages of methacholine. The dosage that caused a 20% fall in FEV1 was used for analysis. The presented data are ratios (month 6/Baseline) of geometric mean PD20 values.
Time Frame Baseline and Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
Per protocol (PP) population: participants of the Intent-to-Treat (ITT) Population (participants who had taken at least one dose of study medication) who completed the study without any major protocol violations. From this population, only participants who had measurements at both baseline and Week 26 have been used for analysis.
Arm/Group Title Salmeterol/FP 50/100 mcg Plus Placebo FP 200 mcg
Hide Arm/Group Description:
Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
FP 200 mcg BID via DISKUS inhaler
Overall Number of Participants Analyzed 65 61
Log Mean (95% Confidence Interval)
Unit of Measure: ratio
2.7
(1.05 to 6.7)
1.5
(0.7 to 2.9)
10.Secondary Outcome
Title Bronchial Hyperresponsiveness With PD20 AMP in Selected Centres
Hide Description Bronchial hyperresponsiveness with PD20 AMP in selected centres was not analyzed, as this outcome measure was removed in a protocol amendment.
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Salmeterol/FP 50/100 mcg Plus Placebo FP 200 mcg
Hide Arm/Group Description:
Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
FP 200 mcg BID via DISKUS inhaler
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Daily FEV1 and PEF Via the Electronic Peak Flow/FEV1 Meter (PIKO-1)
Hide Description Daily FEV1 and PEF via the electronic pea kflow/FEV1 meter (PIKO-1) was not assessed because data from the peak flow meters could not be used for analysis.
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Salmeterol/FP 50/100 mcg Plus Placebo FP 200 mcg
Hide Arm/Group Description:
Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
FP 200 mcg BID via DISKUS inhaler
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Frequency of Asthma Exacerbations (Discriminated on Severity)
Hide Description The frequency of asthma exacerbations (discriminated on severity) was not analyzed because of the low overall frequency.
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Salmeterol/FP 50/100 mcg Plus Placebo FP 200 mcg
Hide Arm/Group Description:
Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
FP 200 mcg BID via DISKUS inhaler
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Cumulative Number of Symptom-free Weeks Until the End of Treatment
Hide Description This outcome measure was not analyzed due to different insights after protocol finalization; it has become clear that the definition of good and maximal controlled weeks is not very distinctive and can therefore actually not be used.
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Salmeterol/FP 50/100 mcg Plus Placebo FP 200 mcg
Hide Arm/Group Description:
Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
FP 200 mcg BID via DISKUS inhaler
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Weekly Percentage of Participants With ‘Good Controlled Weeks’ and ‘Maximal Controlled Weeks’
Hide Description This outcome measure was not analyzed due to different insights after protocol finalization; it has become clear that the definition of good and maximal controlled weeks is not very distinctive and can therefore actually not be used.
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Salmeterol/FP 50/100 mcg Plus Placebo FP 200 mcg
Hide Arm/Group Description:
Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
FP 200 mcg BID via DISKUS inhaler
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
15.Secondary Outcome
Title Time to Asthma Control, Defined as the Time to First ‘Good Controlled Week’ or ‘Maximum Controlled Week'
Hide Description This outcome measure was not analyzed due to different insights after protocol finalization; it has become clear that the definition of good and maximal controlled weeks is not very distinctive and can therefore actually not be used.
Time Frame 26 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Salmeterol/FP 50/100 mcg Plus Placebo FP 200 mcg
Hide Arm/Group Description:
Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
FP 200 mcg BID via DISKUS inhaler
Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Salmeterol/FP 50/100 mcg Plus Placebo FP 200 mcg
Hide Arm/Group Description Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler FP 200 mcg BID via DISKUS inhaler
All-Cause Mortality
Salmeterol/FP 50/100 mcg Plus Placebo FP 200 mcg
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Salmeterol/FP 50/100 mcg Plus Placebo FP 200 mcg
Affected / at Risk (%) Affected / at Risk (%)
Total   2/78 (2.56%)   3/80 (3.75%) 
Musculoskeletal and connective tissue disorders     
Reactive arthritis  1  0/78 (0.00%)  1/80 (1.25%) 
Bone cyst  1  0/78 (0.00%)  1/80 (1.25%) 
Respiratory, thoracic and mediastinal disorders     
Worsening of asthma  1  2/78 (2.56%)  0/80 (0.00%) 
Hyperventilation  1  0/78 (0.00%)  1/80 (1.25%) 
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 5%
Salmeterol/FP 50/100 mcg Plus Placebo FP 200 mcg
Affected / at Risk (%) Affected / at Risk (%)
Total   40/78 (51.28%)   44/80 (55.00%) 
Nervous system disorders     
Headache  1  14/78 (17.95%)  21/80 (26.25%) 
Respiratory, thoracic and mediastinal disorders     
Common cold  1  28/78 (35.90%)  17/80 (21.25%) 
Sore throat  1  8/78 (10.26%)  6/80 (7.50%) 
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
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00197106     History of Changes
Other Study ID Numbers: SAM101667
First Submitted: September 9, 2005
First Posted: September 20, 2005
Results First Submitted: September 11, 2009
Results First Posted: December 14, 2009
Last Update Posted: March 14, 2017