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Trial record 15 of 318 for:    FLUTICASONE AND SALMETEROL

A 12-Month Study Comparing Fluticasone Propionate/Salmeterol (ADVAIR) DISKUS Combination Product 250/50mcg BID To Fluticasone Propionate (FLOVENT) DISKUS 250 mcg BID In Symptomatic Subjects With Asthma

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ClinicalTrials.gov Identifier: NCT00452699
Recruitment Status : Completed
First Posted : March 27, 2007
Results First Posted : February 15, 2010
Last Update Posted : December 8, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Asthma
Interventions Drug: Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID
Drug: Fluticasone propionate 250 mcg BID
Enrollment 621
Recruitment Details  
Pre-assignment Details  
Arm/Group Title FSC DISKUS 250/50 mcg BID for 52 Weeks FP DISKUS 250 mcg BID for 52 Weeks
Hide Arm/Group Description Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
Period Title: Overall Study
Started 306 315
Completed 225 242
Not Completed 81 73
Reason Not Completed
Adverse Event             10             3
Lack of Efficacy             6             4
Lost to Follow-up             6             9
Protocol Violation             21             25
Withdrawal by Subject             26             25
Other             12             7
Arm/Group Title FSC DISKUS 250/50 mcg BID for 52 Weeks FP DISKUS 250 mcg BID for 52 Weeks Total
Hide Arm/Group Description Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks Total of all reporting groups
Overall Number of Baseline Participants 306 315 621
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 306 participants 315 participants 621 participants
36.8  (15.52) 39.3  (15.52) 38.1  (15.55)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 306 participants 315 participants 621 participants
Female
191
  62.4%
201
  63.8%
392
  63.1%
Male
115
  37.6%
114
  36.2%
229
  36.9%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 306 participants 315 participants 621 participants
White 197 208 405
African American 63 61 124
Asian 39 41 80
American Indian 3 4 7
Other 4 1 5
1.Primary Outcome
Title Mean Change From Baseline in Pre-dose FEV1 Over Weeks 1-52
Hide Description Pulmonary function was measured by forced expiratory volume in one second (FEV1), which is the volume of air exhaled from the lungs in one second. Change from baseline was calculated as the average of the Week 1 through Week 52 values minus the baseline value.
Time Frame Baseline and Week 1 through Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat (ITT) Population: all participants randomized to study drug
Arm/Group Title FSC DISKUS 250/50 mcg BID for 52 Weeks FP DISKUS 250 mcg BID for 52 Weeks
Hide Arm/Group Description:
Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
Overall Number of Participants Analyzed 306 315
Mean (Standard Error)
Unit of Measure: Liters
0.20  (0.017) 0.09  (0.015)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FSC DISKUS 250/50 mcg BID for 52 Weeks, FP DISKUS 250 mcg BID for 52 Weeks
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean Difference
Estimated Value 0.11
Confidence Interval 95%
0.07 to 0.15
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Mean Change From Baseline in AM PEF Over Weeks 1-52
Hide Description Morning (AM) peak expiratory flow (PEF) is defined as the maximum volume of air exhaled in liters per minute. Change from baseline was calculated as the average of the Week 1 through Week 52 values minus the baseline value.
Time Frame Baseline and Week 1 through Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT Population who had a minimum of 1 week PEF values
Arm/Group Title FSC DISKUS 250/50 mcg BID for 52 Weeks FP DISKUS 250 mcg BID for 52 Weeks
Hide Arm/Group Description:
Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
Overall Number of Participants Analyzed 299 313
Mean (Standard Error)
Unit of Measure: Liters/minute (L/min)
23.6  (2.47) 9.8  (2.40)
3.Secondary Outcome
Title Mean Change From Baseline in the Percentage of Symptom-free Days Over Weeks 1-52
Hide Description A symptom-free day was defined as a day without asthma symptoms, as measured via the daily asthma symptom score (measuring symptoms during the day and previous night) on a 6-point scale (ranging from 0 to 5). A symptom score of 0=no symptoms, 1=symptoms for one short period, 2=symptoms for two or more short periods, 3=symptoms that did not affect normal daily activities, 4=symptoms that did affect normal daily activities, 5=symptoms so severe that daily activities could not be performed. Change from baseline was calculated as the average of the Week 1-Week 52 values minus the baseline value.
Time Frame Baseline and Week 1 through Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT Population for which at least 1 week of diary data were provided
Arm/Group Title FSC DISKUS 250/50 mcg BID for 52 Weeks FP DISKUS 250 mcg BID for 52 Weeks
Hide Arm/Group Description:
Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
Overall Number of Participants Analyzed 299 313
Mean (Standard Error)
Unit of Measure: Percentage of symptom-free days
37.1  (2.02) 28.5  (1.90)
4.Secondary Outcome
Title Rate of Asthma Attacks Per Participant Per Year
Hide Description The rate of asthma attacks was defined as the mean number of attacks per participant per year. An asthma attack was defined as a 20% decrease in AM PEF, a 70% increase in albuterol use, or the occurrence of an asthma exacerbation requiring oral steroids or hospitalization.
Time Frame Week 1 through Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title FSC DISKUS 250/50 mcg BID for 52 Weeks FP DISKUS 250 mcg BID for 52 Weeks
Hide Arm/Group Description:
Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
Overall Number of Participants Analyzed 306 315
Mean (95% Confidence Interval)
Unit of Measure: attacks per participant per year
1.87
(1.36 to 2.59)
2.14
(1.55 to 2.96)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title FSC DISKUS 250/50 mcg BID for 52 Weeks FP DISKUS 250 mcg BID for 52 Weeks
Hide Arm/Group Description Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
All-Cause Mortality
FSC DISKUS 250/50 mcg BID for 52 Weeks FP DISKUS 250 mcg BID for 52 Weeks
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
FSC DISKUS 250/50 mcg BID for 52 Weeks FP DISKUS 250 mcg BID for 52 Weeks
Affected / at Risk (%) Affected / at Risk (%)
Total   14/306 (4.58%)   10/315 (3.17%) 
Blood and lymphatic system disorders     
Deep vein thrombosis  1  1/306 (0.33%)  0/315 (0.00%) 
Phlebitis  1  0/306 (0.00%)  1/315 (0.32%) 
Iron deficiency anemia  1  1/306 (0.33%)  0/315 (0.00%) 
Cardiac disorders     
Myocardial infarction  1  0/306 (0.00%)  1/315 (0.32%) 
Myocardial ischemia  1  0/306 (0.00%)  1/315 (0.32%) 
Gastrointestinal disorders     
Small intestinal obstruction  1  0/306 (0.00%)  1/315 (0.32%) 
Infections and infestations     
Amoebic dysentery  1  1/306 (0.33%)  0/315 (0.00%) 
Cellulitis  1  0/306 (0.00%)  1/315 (0.32%) 
Localized infection  1  0/306 (0.00%)  1/315 (0.32%) 
Salmonellosis  1  1/306 (0.33%)  0/315 (0.00%) 
Food poisoning  1  1/306 (0.33%)  0/315 (0.00%) 
Injury, poisoning and procedural complications     
Post procedural complication  1  1/306 (0.33%)  0/315 (0.00%) 
Musculoskeletal and connective tissue disorders     
Inguinal hernia, obstructive  1  0/306 (0.00%)  1/315 (0.32%) 
Ulna fracture  1  1/306 (0.33%)  0/315 (0.00%) 
Arthritis  1  1/306 (0.33%)  0/315 (0.00%) 
Nervous system disorders     
Cerebrovascular accident  1  0/306 (0.00%)  1/315 (0.32%) 
Migraine  1  1/306 (0.33%)  0/315 (0.00%) 
Pregnancy, puerperium and perinatal conditions     
Premature baby  1  0/306 (0.00%)  1/315 (0.32%) 
Psychiatric disorders     
Acute psychosis  1  1/306 (0.33%)  0/315 (0.00%) 
Depression  1  0/306 (0.00%)  1/315 (0.32%) 
Respiratory, thoracic and mediastinal disorders     
Asthma (exacerbation)  1  3/306 (0.98%)  0/315 (0.00%) 
Pneumonia  1  2/306 (0.65%)  0/315 (0.00%) 
Pulmonary embolism  1  1/306 (0.33%)  0/315 (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 5%
FSC DISKUS 250/50 mcg BID for 52 Weeks FP DISKUS 250 mcg BID for 52 Weeks
Affected / at Risk (%) Affected / at Risk (%)
Total   183/306 (59.80%)   203/315 (64.44%) 
Infections and infestations     
Upper Respiratory Tract Infection  1  62/306 (20.26%)  96/315 (30.48%) 
Nasopharyngitis  1  54/306 (17.65%)  56/315 (17.78%) 
Bronchitis  1  20/306 (6.54%)  31/315 (9.84%) 
Influenza  1  22/306 (7.19%)  25/315 (7.94%) 
Sinusitis  1  17/306 (5.56%)  27/315 (8.57%) 
Musculoskeletal and connective tissue disorders     
Back Pain  1  20/306 (6.54%)  14/315 (4.44%) 
Nervous system disorders     
Headache  1  56/306 (18.30%)  59/315 (18.73%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  27/306 (8.82%)  19/315 (6.03%) 
Oropharyngeal Pain  1  14/306 (4.58%)  20/315 (6.35%) 
Allergic Rhinitis  1  13/306 (4.25%)  18/315 (5.71%) 
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: NCT00452699     History of Changes
Other Study ID Numbers: ADA109055
First Submitted: March 26, 2007
First Posted: March 27, 2007
Results First Submitted: January 14, 2010
Results First Posted: February 15, 2010
Last Update Posted: December 8, 2016