An Evaluation of Efficacy and Safety of Corresponding Doses of Pulmicort Turbuhaler® and Pulmicort Respules® in Japanese Asthmatic Adult Patients (Open, Multicenter, Phase III Study)

NCT00855959 Phase 3 COMPLETED Results posted

The primary objective of the study is to show similarity of efficacy on Pulmicort Respules 1.0 mg/day or 2.0 mg/day for 6 weeks in the treatment period and the corresponding doses of Pulmicort Turbuhaler 400 μg/day or 800 μg/day for 4 weeks in the observation period in Japanese adult asthmatic patients with age of 16 years or older.

Details

Lead sponsor	AstraZeneca
Phase	Phase 3
Status	COMPLETED
Enrolment	108
Start date	2009-02
Completion	2009-08

Conditions

• Asthma

Interventions

• Budesonide
• Pulmicort Turbuhaler

Primary outcomes

• Morning Peak Expiratory Flow (mPEF) — 6 weeks
  Change in morning peak expiratory flow (mPEF) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)

Countries

Japan