Randomized, Placebo-controlled Study Comparing Efficacy of Fluticasone/Salmeterol Combination to Advair in Asthmatics

NCT02496715 | Withdrawn Phase 3

• 1 other identifier: ACT-2014-075
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• 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

  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 Outcomes (3)

• Change in Forced Vital Capacity (FVC) results at the times of FEV1 measurements

  Day 1 and Day 28

• Daily rescue medication used

  8 weeks

• Number and type of adverse events

  8 weeks

Study Arms (3)

Treatment 1

EXPERIMENTAL

Generic fluticasone propionate 100 mcg / salmeterol 50 mcg. Single puff, twice daily (approximately every 12 hr) for 4 weeks

Drug: Generic fluticasone propionate 100 mcg / salmeterol 50 mcg

Treatment 2

EXPERIMENTAL

Advair 100/50 Diskus pMDI containing fluticasone propionate 100mcg / salmeterol 50 mcg. Single puff, twice daily (approximately every 12 hr) for 4 weeks

Drug: Fluticasone propionate 100 mcg / salmeterol 50 mcg

Treatment 3

PLACEBO COMPARATOR

Placebo inhalation. Single puff, twice daily (approximately every 12 hr) for 4 weeks

Drug: Placebo

Interventions

Fluticasone propionate 100 mcg / salmeterol 50 mcg DRUG

Brand inhaler containing pMDI containing fluticasone and salmeterol

Also known as: Advair

Treatment 2

Generic fluticasone propionate 100 mcg / salmeterol 50 mcg DRUG

Generic inhaler containing pMDI containing fluticasone and salmeterol

Also known as: Generic Test

Treatment 1

Placebo DRUG

Placebo inhaler

Treatment 3

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Actavis Inc.: lead

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Beverley Patterson, PhD

  Actavis Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2015
• First Posted: July 14, 2015
• Study Start: September 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: December 1, 2016
• Last Updated: July 5, 2019

Record last verified: 2019-07