- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02496715
Randomized, Placebo-controlled Study Comparing Efficacy of Fluticasone/Salmeterol Combination to Advair in Asthmatics
Randomized, Parallel, Placebo-controlled, Multiple Dose, Multicenter Study to Compare the Efficacy of Fluticasone/Salmeterol (Test) to Advair® Diskus (GSK) in Adult Asthma Patients
Study Overview
Status
Conditions
Detailed Description
This pivotal trial will examine therapeutic equivalence of a new generic fixed-dose combination product containing fluticasone propionate 100 mcg / salmeterol 50 mcg (as xinafoate salt) and reference listed drug (RLD) Advair® Diskus 100/50 in adult patients with chronic but stable asthma as defined in National Asthma Education and Prevention Program Expert Panel Report 3 (NAEPP 3) guidelines [2]. To ensure adequate study sensitivity the test and reference products should both be statistically superior to placebo (p<0.05) with regard to the BE study primary endpoints.
A secondary study objective is the safety and tolerability of the test compound.
Study Type
Phase
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Adult male or female subjects of non-childbearing or of childbearing potential committed to consistent and correct use of an acceptable method of birth control
- Diagnosed with asthma, as defined by the National Asthma Education and Prevention Program (NAEPP),5 at least 6 months prior to screening
- Moderate-to-severe asthma with a pre-bronchodilator FEV1 of >45% and <85% of predicted normal, measured at least 6 hours after short-acting β agonist (SABA)and at least 24 hours after the last dose of long-acting β agonist (LABA), at the screening visit and on the day of treatment
- >15% and >0.20 L reversibility of FEV1 within 30 minutes following 360 mcg of albuterol inhalation (pMDI)
- Patients should be stable on their chronic asthma treatment regimen for at least 4 weeks prior to enrollment
- Currently non-smoking; having not used tobacco products (i.e., cigarettes, cigars, pipe tobacco) within the past year, and having < 10 pack-years of historical use
- Able to replace current regularly scheduled short-acting β agonists (SABAs) with salbutamol/albuterol inhaler for use only on an as-needed basis for the duration of the study (subjects should be able to withhold all inhaled SABAs for at least 6 hours prior to lung function assessments on study visits)
- Willing to discontinue their asthma medications (inhaled corticosteroids and long-acting β agonists) during the run-in period and for the remainder of the study
- Willingness to give their written informed consent to participate in the study
Exclusion Criteria:
- Life-threatening asthma, defined as a history of asthma episodes(s) requiring intubation, and/or associated with hypercapnia, respiratory arrest or hypoxic seizures, asthma-related syncopal episodes(s), or hospitalizations within the past year or during the run-in period
- Significant respiratory disease other than asthma (chronic obstructive pulmonary disease (COPD), interstitial lung disease, etc.)
- Evidence or history of clinically significant disease or abnormality including congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infarction, or cardiac dysrhythmia. In addition,historical or current evidence of significant hematologic, hepatic, neurologic, psychiatric, renal, or other diseases that, in the opinion of the investigator, would put the patient at risk through study participation, or would affect the study analyses if the disease exacerbated during the study
- Patients who required systemic corticosteroids (for any reason) within the past 4 weeks
- Hypersensitivity to any sympathomimetic drug (e.g., formoterol or albuterol) or any inhaled, intranasal, or systemic corticosteroid therapy
- Patients currently receiving β-blockers
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment 1
Generic fluticasone propionate 100 mcg / salmeterol 50 mcg.
Single puff, twice daily (approximately every 12 hr) for 4 weeks
|
Generic inhaler containing pMDI containing fluticasone and salmeterol
Other Names:
|
Experimental: Treatment 2
Advair 100/50 Diskus pMDI containing fluticasone propionate 100mcg / salmeterol 50 mcg.
Single puff, twice daily (approximately every 12 hr) for 4 weeks
|
Brand inhaler containing pMDI containing fluticasone and salmeterol
Other Names:
|
Placebo Comparator: Treatment 3
Placebo inhalation.
Single puff, twice daily (approximately every 12 hr) for 4 weeks
|
Placebo inhaler
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Baseline-corrected area under the serial Forced Expiratory Volume in the first second (FEV1)-time effect curve calculated from time zero to 12 hours on the first day of the treatment
Time Frame: up to 12 hours
|
Baseline-corrected area under the serial FEV1-time effect curve calculated from time zero to 12 hours on the first day of the treatment (Visit 2, Day 1) to assess equivalence of test drug with reference listed drug (RLD) Advair® Diskus® 100/50, and to assess superiority over placebo
|
up to 12 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Forced Vital Capacity (FVC) results at the times of FEV1 measurements
Time Frame: Day 1 and Day 28
|
Day 1 and Day 28
|
|
Daily rescue medication used
Time Frame: 8 weeks
|
The type and frequency of rescue medication used
|
8 weeks
|
Number and type of adverse events
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Beverley Patterson, PhD, Actavis Inc.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Adrenergic Agonists
- Dermatologic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Anti-Allergic Agents
- Adrenergic beta-2 Receptor Agonists
- Adrenergic beta-Agonists
- Fluticasone
- Xhance
- Salmeterol Xinafoate
Other Study ID Numbers
- ACT-2014-075
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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