A Randomized, Blinded, Parallel Group, Placebo-Controlled, Multiple Dose, Multicenter Study to Compare the Therapeutic Equivalence of Fluticasone Propionate Pressurized Metered Dose Inhaler, 110 mcg, to Flovent® HFA 110 mcg, in Adult Subjects With Asthma

Actavis Inc.1 site in 1 country1,902 target enrollmentMarch 25, 2019

ConditionsAsthma

InterventionsPlacebo pressurized metered dose inhaler Fluticasone propionate pressurized metered dose inhaler Flovent HFA pressurized metered dose inhaler

DrugsFluticasone propionate pressurized metered dose inhaler Flovent HFA pressurized metered dose inhaler Placebo pressurized metered dose inhaler

Overview

Phase: Phase 3
Intervention: Placebo pressurized metered dose inhaler
Conditions: Asthma
Sponsor: Actavis Inc.
Enrollment: 1902
Locations: 1
Primary Endpoint: Mean change in baseline adjusted morning pre-dose FEV1 from the time of treatment randomization to Week 4.
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

A Randomized, Blinded, Parallel Group, Placebo-Controlled, Multiple Dose, Multicenter Study to Compare the Therapeutic Equivalence of Fluticasone Propionate Pressurized Metered Dose Inhaler, 110 mcg, to Flovent® HFA 110 mcg, in Adult Subjects with Asthma.

Registry

clinicaltrials.gov

Start Date

March 25, 2019

End Date

July 9, 2021

Last Updated

4 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Actavis Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult ≥18 and ≤75 years of age male or female subjects of non-child bearing potential or of child bearing potential committing to consistent and correct use of an acceptable method of birth control.
•Body mass index (BMI) ≥18 and ≤
•Diagnosis of asthma, as defined by the NAEPP-EPR3 at least 12 months prior to Enrollment at Screening Visit 1a.
•Pre bronchodilator highest forced expiratory volume in 1 second (FEV1) ≥45% and ≤85% of predicted normal value at Screening Visit 1b and on the first day of treatment prior to randomization.
•Reversibility of airway obstruction ≥15% of FEV1 within 30 minutes of 360mcg albuterol inhalation (4 puffs).
•Subjects should be stable on their chronic asthma treatment regimen for at least 4 weeks prior to Enrollment at Screening Visit 1a.
•Currently non-smoking, defined as abstinence from all smoking, including marijuana and all tobacco products (i.e., e-cigarettes, cigarettes, cigars, pipe, ortobacco) within the past year, a negative cotinine screening test at Screening Visit 1b, and \<10 pack years of historical use.
•Able to replace current short-acting β agonist (SABA) with study issued albuterol inhaler for use as needed for the duration of the study.
•Able to withhold all inhaled SABAs for at least 6 hours prior to lung function assessments on study visits.
•Able to withhold all inhaled long acting β agonists (LABA) 24 hours before Screening Visit 1b.

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 episode(s), or hospitalizations due to asthma within the past year prior to Enrollment, or during the Screening or Run-in period.
•History of significant respiratory disease other than asthma (e.g., chronic obstructive pulmonary disease \[COPD\], interstitial lung disease, chronic bronchitis, emphysema, 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, cardiovascular, endocrine, or other diseases that, in the opinion of the Investigator, would put the subject at risk through study participation, or would affect the study analyses if the disease exacerbates during the study.
•Viral or bacterial, upper/lower respiratory tract infection (U/LRTI), or sinus, or middle ear infection within 4 weeks prior to Screening Visit 1b, during the Run-in period, or on the first day of treatment prior to randomization.
•Hypersensitivity to any sympathomimetic drug (e.g., albuterol) or any inhaled, intranasal, or systemic corticosteroid therapy.
•Hypersensitivity to any of the ingredients of FP pMDI or Flovent HFA.
•Subjects receiving β2 blockers, anti-arrhythmics, anti-depressants, and/or monoamine oxidase inhibitors within 4 weeks prior to Screening Visit 1b.
•Subjects who required systemic or oral corticosteroids (for any reason) within the past 6 months prior to Screening Visit 1b.
•Subjects receiving medications that are strong cytochrome P4503A4 inhibitors (e.g., ritonavir, ketoconazole, itraconazole) within 2 weeks prior to Screening Visit 1b.
•Subjects receiving any approved or investigational biological treatment for asthma (e.g., omalizumab, mepolizumab) within 6 months prior to Screening Visit 1b.