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Study to Assess the Efficacy and Safety of Beclomethasone Dipropionate in Adolescent and Adult Patients 12 Years of Age and Older With Persistent Asthma

NCT02513160 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 713

Last updated 2021-11-09

Study results available
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Summary

The primary objective of this study is to evaluate the efficacy of beclomethasone dipropionate administered via BAI at a dose strength of 40 or 80 mcg per oral inhalation (320 or 640 mcg/day, respectively) compared with placebo treatment in patients with persistent asthma as assessed by the standardized baseline-adjusted trough morning (pre-dose and pre-rescue bronchodilator) forced expiratory volume in 1 second (FEV1) area under the effect curve from time 0 to 6 weeks (AUEC\[0-6wk\]).

Conditions

  • Persistent Asthma

Interventions

DRUG

Beclomethasone Dipropionate 640

Beclomethasone Dipropionate 640 mcg BAI

DRUG

Placebo

Placebo, taken in the morning and evening each day, was provided in matching BAI and MDI devices. The placebo devices were identical to the devices used to deliver active drug.

DRUG

Beclomethasone dipropionate via 320 mcg BAI

Beclomethasone dipropionate treatment administered via breath-actuated inhaler (BAI) (320 mcg/day).

DRUG

albuterol/salbutamol

Each patient's current rescue medication was replaced with study-supplied albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent during the run-in and double-blind study periods.

DRUG

Beclomethasone dipropionate via 320 mcg MDI

Beclomethasone dipropionate treatment administered via metered-dose inhaler (MDI) (320 mcg/day).

Sponsors & Collaborators

  • Teva Branded Pharmaceutical Products R&D, Inc.

    lead INDUSTRY

Principal Investigators

  • Teva Medical Expert, MD · Teva Branded Pharmaceutical Products R&D, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02513160 on ClinicalTrials.gov