A Randomized Single Blind Placebo-Controlled Multi-Center Study Comparing Combination Therapy With Fluticasone Propionate 100 mcg and Salmeterol 50 mcg Inhalation Powder to Combination Therapy With ADVAIR DISKUS® 100/50 (Fluticasone Propionate 100 mcg and Salmeterol 50 mcg Inhalation Powder) in Treatment of Subjects With Asthma

Amneal Ireland Limited0 sites1,204 target enrollmentOctober 2018

ConditionsAsthma

InterventionsTest Product Reference Product Placebo

DrugsTest Product Reference Product Placebo

Overview

Phase: Phase 3
Intervention: Test Product
Conditions: Asthma
Sponsor: Amneal Ireland Limited
Enrollment: 1204
Primary Endpoint: Baseline-adjusted area under the serial FEV1-time curve
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

To compare the efficacy and safety profiles of Fluticasone Propionate 100 mcg and Salmeterol 50 mcg Inhalation Powder (test product) and ADVAIR DISKUS (fluticasone propionate 100 mcg and salmeterol 50 mcg inhalation powder) (reference product) and to show that the efficacy of the 2 active products is superior to that of placebo in the treatment of subjects with asthma.

Registry

clinicaltrials.gov

Start Date

October 2018

End Date

June 2019

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Amneal Ireland Limited

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female subjects (≥ 12 years of age) of non-child bearing potential or of child bearing potential committing 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) at least 12 weeks prior to screening.
•Pre-bronchodilator FEV1 of ≥40% and ≤85% of the predicted value during the screening visit and on the first day of treatment.
•Currently non-smoking; had not used tobacco products (i.e., cigarettes, cigars, pipe tobacco) within the past year, and had ≤ 10 pack-years of historical use.
•≥15% reversibility of FEV1 within 30 minutes following 360 mcg of albuterol inhalation (pMDI).
•Able to discontinue their asthma medications (inhaled corticosteroids and long-acting β agonists) during the run-in period and for remainder of the study.
•Able to replace current short-acting β agonists (SABAs) with salbutamol/albuterol inhaler for use as needed 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).
•Able to continue the following medications without a significant adjustment of dosage, formulation, dosing interval for the duration of the study, and judged able by the investigator to withhold them for the specified minimum time intervals prior to each clinic visit:
•short-acting forms of theophylline 12 hours
•twice-a-day controlled-release forms of theophylline 24 hours

Exclusion Criteria

•Life-threatening asthma, defined as a history of asthma episode(s) requiring intubation, and/or associated with hypercapnoea; respiratory arrest or hypoxic seizures, asthma related syncopal episode(s), or hospitalizations within the past year or during the run-in period.
•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.
•Hypersensitivity to any sympathomimetic drug (e.g., salmeterol or albuterol) or any inhaled, intranasal, or systemic corticosteroid therapy.
•Medication(s) with the potential to affect the course of asthma or to interact with sympathomimetic amines, e.g.:
•β-blockers
•oral decongestants
•benzodiazepines
•digitalis
•phenothiazines
•polycyclic antidepressants