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Trial record 2 of 318 for:    FLUTICASONE AND SALMETEROL

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

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ClinicalTrials.gov Identifier: NCT00452348
Recruitment Status : Completed
First Posted : March 27, 2007
Results First Posted : February 15, 2010
Last Update Posted : December 9, 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 628
Recruitment Details  
Pre-assignment Details  
Arm/Group Title FSC DISKUS 250/50 mcg BID 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 310 318
Completed 231 234
Not Completed 79 84
Reason Not Completed
Adverse Event             6             9
Lack of Efficacy             10             9
Lost to Follow-up             14             8
Protocol Violation             22             28
Withdrawal by Subject             18             21
Other             9             9
Arm/Group Title FSC DISKUS 250/50 mcg BID 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 310 318 628
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 310 participants 318 participants 628 participants
40.9  (15.71) 39.6  (16.56) 40.2  (16.15)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 310 participants 318 participants 628 participants
Female
186
  60.0%
181
  56.9%
367
  58.4%
Male
124
  40.0%
137
  43.1%
261
  41.6%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 310 participants 318 participants 628 participants
White 254 262 516
African American 29 27 56
Asian 20 25 45
American Indian 2 0 2
Other 5 4 9
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 who had at least one on-treatment FEV1
Arm/Group Title FSC DISKUS 250/50 mcg BID 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 303 304
Mean (Standard Error)
Unit of Measure: Liters
0.16  (0.017) 0.12  (0.020)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection FSC DISKUS 250/50 mcg BID, 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 0.090
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least Squares Mean
Estimated Value 0.04
Confidence Interval 95%
-0.01 to 0.09
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 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 305 310
Mean (Standard Error)
Unit of Measure: Liters/minute (L/min)
27.7  (2.85) 14.6  (2.49)
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 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 305 310
Mean (Standard Error)
Unit of Measure: Percentage of symptom-free days
37.4  (2.03) 28.9  (1.82)
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 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 310 318
Mean (95% Confidence Interval)
Unit of Measure: attacks per participant per year
2.63
(2.17 to 3.19)
2.73
(2.26 to 3.31)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title FSC DISKUS 250/50 mcg BID 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 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 FP DISKUS 250 mcg BID for 52 Weeks
Affected / at Risk (%) Affected / at Risk (%)
Total   7/310 (2.26%)   9/318 (2.83%) 
Blood and lymphatic system disorders     
Anaemia  1  1/310 (0.32%)  0/318 (0.00%) 
Cardiac disorders     
Atrial fibrillation  1  1/310 (0.32%)  0/318 (0.00%) 
Gastrointestinal disorders     
Large intestine perforation  1  0/310 (0.00%)  1/318 (0.31%) 
General disorders     
Cardiac death  1  1/310 (0.32%)  0/318 (0.00%) 
Chest pain  1  0/310 (0.00%)  1/318 (0.31%) 
Hepatobiliary disorders     
Cholelithiasis  1  0/310 (0.00%)  2/318 (0.63%) 
Infections and infestations     
Cholecystitis  1  0/310 (0.00%)  1/318 (0.31%) 
Appendicitis  1  0/310 (0.00%)  1/318 (0.31%) 
Cellulitis  1  0/310 (0.00%)  1/318 (0.31%) 
Injury, poisoning and procedural complications     
Ankle fracture  1  1/310 (0.32%)  0/318 (0.00%) 
Foot fracture  1  0/310 (0.00%)  1/318 (0.31%) 
Humerus fracture  1  0/310 (0.00%)  1/318 (0.31%) 
Tibia fracture  1  0/310 (0.00%)  1/318 (0.31%) 
Nervous system disorders     
Syncope  1  0/310 (0.00%)  1/318 (0.31%) 
Pregnancy, puerperium and perinatal conditions     
Abortion spontaneous  1  0/310 (0.00%)  1/318 (0.31%) 
Reproductive system and breast disorders     
Breast cancer  1  1/310 (0.32%)  1/318 (0.31%) 
Ovarian cyst  1  1/310 (0.32%)  0/318 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  1/310 (0.32%)  0/318 (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 FP DISKUS 250 mcg BID for 52 Weeks
Affected / at Risk (%) Affected / at Risk (%)
Total   184/310 (59.35%)   201/318 (63.21%) 
Infections and infestations     
Upper respiratory tract infection  1  45/310 (14.52%)  55/318 (17.30%) 
Nasopharyngitis  1  54/310 (17.42%)  70/318 (22.01%) 
Bronchitis  1  34/310 (10.97%)  38/318 (11.95%) 
Influenza  1  15/310 (4.84%)  21/318 (6.60%) 
Sinusitis  1  33/310 (10.65%)  40/318 (12.58%) 
Rhinitis  1  23/310 (7.42%)  18/318 (5.66%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  23/310 (7.42%)  24/318 (7.55%) 
Nervous system disorders     
Headache  1  51/310 (16.45%)  60/318 (18.87%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  19/310 (6.13%)  18/318 (5.66%) 
Oropharyngeal pain  1  23/310 (7.42%)  19/318 (5.97%) 
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
Publications:
Kerwin E, Prazma CM, Sutton L, Stempel DA. Safety and efficacy of long-term treatment with fluticasone propionate and salmeterol via DISKUS versus fluticasone propionate alone. Clin Res Reg Aff 2011;28(1):14-21.
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00452348     History of Changes
Other Study ID Numbers: ADA109057
First Submitted: March 26, 2007
First Posted: March 27, 2007
Results First Submitted: January 20, 2010
Results First Posted: February 15, 2010
Last Update Posted: December 9, 2016