A 52-week, Randomized, Double-Blind, Parallel-Group Study of Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 mcg BID and Fluticasone Propionate (FP) DISKUS 250 mcg BID in Treatment of Subjects With Asthma

GlaxoSmithKline1 site in 1 country628 target enrollmentMay 2007

ConditionsAsthma

InterventionsFluticasone propionate 250 mcg BID Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID

DrugsFluticasone Propionate/salmeterol xinofoate 250/50 mcg BID Fluticasone propionate 250 mcg BID

Overview

Phase: Phase 4
Intervention: Fluticasone propionate 250 mcg BID
Conditions: Asthma
Sponsor: GlaxoSmithKline
Enrollment: 628
Locations: 1
Primary Endpoint: Mean Change From Baseline in Pre-dose FEV1 Over Weeks 1-52
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This purpose of this study is to show the superiority and long term safety and efficacy of adding a long acting beta agonist (salmeterol) to constant dose of an inhaled corticosteroid (fluticasone propionate) in symptomatic subjects with asthma. The 12-month assessment of asthma control will provide key information on the efficacy and safety of the combination therapy. The safety measure will be an assessment of adverse events

Registry

clinicaltrials.gov

Start Date

May 2007

End Date

April 2009

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects eligible for enrollment in the study must meet all of the following criteria:
•Consent: A signed and dated written informed consent must be obtained from the subject and/or subject's legally acceptable representative prior to study participation.
•Type of Subject: Outpatient
•Gender: Male or female Females are eligible to participate only if they are currently non-pregnant and non-lactating.
•A female is eligible to enter and participate in the study if she is:
•of non-child-bearing potential; OR
•of child-bearing potential but has a negative urinary pregnancy test at Screening (Visit 1 and when specified in Appendix 1) and agrees to take contraceptive precautions (including abstinence) which are adequate to prevent pregnancy during the study.
•Acceptable methods of contraception \[Hatcher, 2004\] are:
•Abstinence
•oral contraceptive (either combined or progestogen only)

Exclusion Criteria

•Subjects meeting any of the following criteria must not be enrolled in the study:
•1.Life-Threatening Asthma: A subject must not have life-threatening asthma. Life-threatening asthma is defined for this protocol as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, or hypoxic seizures, or asthma-related syncopal episode(s) within the 12 months prior to screening (Visit 1).
•2.Worsening of Asthma: A subject must not have experienced a worsening of asthma which involved an ER visit, hospitalization or use of oral/parenteral corticosteroids within 4 weeks of screening (Visit 1).
•3.Intermittent, Seasonal, or Exercise-Induced Asthma Alone: Subjects with only intermittent or seasonal or exercise-induced asthma are excluded from participation in this study.
•4.Concurrent Respiratory Disease: A subject must not have current evidence of pneumonia, pneumothorax, atelectasis, pulmonary fibrotic disease, chronic bronchitis, emphysema, chronic obstructive pulmonary disease, or other respiratory abnormalities other than asthma.
•5.Concurrent Conditions/Diseases: A subject with historical or current evidence of any clinically significant, co-morbid or uncontrolled condition or disease state that, in the opinion of the investigator, would put the safety of the subject at risk through study participation or would confound the interpretation of the results if the condition/disease exacerbated during the study.
•The list of excluded conditions/diseases includes, but is not limited to:
•congestive heart failure known aortic aneurysm clinically significant coronary clinically significant cardiac arrhythmia heart disease stroke within 3 months of screening (Visit 1) uncontrolled hypertension coronary artery disease hematologic, hepatic, or renal disease cystic fibrosis poorly controlled peptic ulcer dyspnea by any other cause than asthma gastroesophageal reflux disease (GERD) not controlled by pharmacotherapy and may be causing/contributing to subject's respiratory symptoms thyrotoxicosis hypokalemia immunologic compromise current malignancy1 tuberculosis (current or quiescent) Cushing's or Addison's disease pneumonia, pneumothorax, chronic bronchitis or atelectasis uncontrolled diabetes mellitus recent history of drug or alcohol abuse 1.history of malignancy is acceptable only if subject has been in remission for one year prior to screening (Visit 1; remission = no treatment for the malignancy in the 12 months prior to screening \[Visit 1\])
•Drug Allergy: A subject must not have had any immediate or delayed hypersensitivity to any beta2-agonist; sympathomimetic drug; any intranasal; inhaled or systemic corticosteroid therapy; lactose; or have a severe milk protein allergy.
•Respiratory Tract Infections: A subject must not have had any sinus, middle ear, oropharyngeal, upper or lower respiratory tract infection symptoms that have not resolved at least 7 days immediately preceding screening (Visit 1).

Arms & Interventions

Fluticasone propionate 250 mcg BID

Intervention: Fluticasone propionate 250 mcg BID

Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID

Intervention: Fluticasone Propionate/salmeterol xinofoate 250/50 mcg BID

Outcomes

Primary Outcomes

Mean Change From Baseline in Pre-dose FEV1 Over Weeks 1-52

Time Frame: Baseline and Week 1 through Week 52

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.

Secondary Outcomes

Mean Change From Baseline in AM PEF Over Weeks 1-52(Baseline and Week 1 through Week 52)
Rate of Asthma Attacks Per Participant Per Year(Week 1 through Week 52)
Mean Change From Baseline in the Percentage of Symptom-free Days Over Weeks 1-52(Baseline and Week 1 through Week 52)