Clinical trial NCT02513160
Conditions: Persistent Asthma
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2015-09-30; Completion date: 2016-03-31
Enrollment: 713 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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\[0-6wk\]).

Detailed description:
Run-In Period (Days -14 to Day -1): Participants were provided with single-blind placebo breath-actuated inhaler (BAI) or metered-dose inhaler (MDI) device for twice-daily use after appropriate training and demonstration of the proper technique. Participants discontinued their current asthma therapy for the duration of the study.

Treatment Period (Day 0 to Week 6): Participants were randomly assigned to treatment and device type through a qualified randomization service provider (ie, IRT). The interactive response technology (IRT) system stratified patients based on treatment at the time of screening visit, either inhaled corticosteroid (ICS) or non-corticosteroid (NCS). During the study, blinded persons were blinded to treatment (active or placebo) assigned but not device (BAI or MDI) assignment.

Arms: arm 1: Beclomethasone Dipropionate Delivered via Breath-Actuated Inhaler (BAI) at 320 mcg/day (40 mcg/inhalation, 4 inhalations twice daily)

Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods. arm 2: Beclomethasone Dipropionate Delivered via Breath-Actuated Inhaler (BAI) at 640 mcg/day (80 mcg/inhalation, 4 inhalations twice daily)

Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods. arm 3: Beclomethasone dipropionate Metered Dose Inhaler (MDI) 320 mcg/day (40 mcg/inhalation, 4 inhalations twice daily)

Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods. arm 4: Pooled breath-actuated inhaler (BAI) or metered-dose inhaler (MDI) placebo groups. Participants were instructed to take 4 inhalations twice daily for 6 weeks.

Albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent was supplied by the sponsor for use as rescue medication during the run-in and double-blind study periods.
Interventions: intervention 1: Beclomethasone Dipropionate 640 intervention 2: Placebo intervention 3: Beclomethasone dipropionate via 320 mcg BAI intervention 4: albuterol/salbutamol intervention 5: Beclomethasone dipropionate via 320 mcg MDI
Intervention descriptions: intervention 1: Beclomethasone Dipropionate 640 mcg BAI intervention 2: 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. intervention 3: Beclomethasone dipropionate treatment administered via breath-actuated inhaler (BAI) (320 mcg/day). intervention 4: 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. intervention 5: Beclomethasone dipropionate treatment administered via metered-dose inhaler (MDI) (320 mcg/day).

Protocol documents: