Randomized, Placebo-controlled Study Comparing Efficacy of Fluticasone/Salmeterol Combination to Advair in Asthmatics
Information source: Actavis Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Fluticasone propionate 100 mcg / salmeterol 50 mcg (Drug); Generic fluticasone propionate 100 mcg / salmeterol 50 mcg (Drug); Placebo (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Actavis Inc. Official(s) and/or principal investigator(s): Beverley Patterson, PhD, Study Director, Affiliation: Actavis Inc.
Overall contact: Beverley Patterson, PhD, Phone: +44 207 612 7624, Email: beverley.patterson@actavis.com
Summary
This is a pivotal trial that will examine therapeutic equivalence (BE) 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 the National Asthma Education and Prevention
Program Expert Panel Report 3 (NAEPP 3) guidelines
Clinical Details
Official title: 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 design: Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: 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
Secondary outcome: Change in Forced Vital Capacity (FVC) results at the times of FEV1 measurementsDaily rescue medication used Number and type of adverse events
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.
Eligibility
Minimum age: 12 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Beverley Patterson, PhD, Phone: +44 207 612 7624, Email: beverley.patterson@actavis.com Additional Information
Starting date: September 2015
Last updated: July 13, 2015
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