Conditions: Persistent Asthma
Keywords: asthma breath-actuated inhaler beclomethasone
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 273
Healthy volunteers: no

Brief summary:
This is a randomized, double-blind, placebo-controlled parallel-group study. Participants will be randomly assigned to receive treatment with beclomethasone dipropionate at a dosage of 80 or 160 mcg/day delivered via a Breath-Actuated Inhaler (BAI); or a matching BAI placebo, in a 1:1:1 ratio after a 14- to 21-day run-in period. Participants and investigators will remain blinded to randomized treatment assignment during the study

Detailed description:

Arms:
arm 1: 40 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 80 mcg/day. arm 2: 80 mcg beclomethasone dipropionate (BDP) via breath-actuated inhaler (BAI) twice daily for a total of 160 mcg/day. arm 3: Placebo breath-actuated inhaler (BAI) twice daily.

Interventions: intervention 1: Beclomethasone dipropionate breath-actuated inhaler intervention 2: Placebo breath-actuated inhaler intervention 3: albuterol/salbutamol
Intervention descriptions: intervention 1: Beclomethasone dipropionate (BDP) breath-actuated inhaler (BAI) given in dosages of either 40 mcg/inhalation or 80 mcg/inhalation. Study drug was administered twice each day, in the morning and in the evening, after the completion of the asthma symptom score and the PEF measurements, in that order. intervention 2: Placebo was provided in matching breath-actuated inhaler (BAI) devices. The placebo devices were identical to the devices used to deliver active drug. Placebo was administered twice each day, in the morning and in the evening, after the completion of the asthma symptom score and the PEF measurements, in that order. intervention 3: Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI \[90 mcg ex-actuator\] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period

Protocol document: