At a glance
ClinicalIndex Comparison Record- ✓Minimum 6 months documented history of asthma according to JGL 2006 definition
- ✓Currently receiving prescribed inhaled corticosteroid (ICS) treatment for at least 3 months before Visit 2
- ✓Provision of informed consent prior to any study specific procedures
- ✕Current or previous tobacco smokers with ≥10 pack-year history
- ✕Use of β-blockers including eye drops
- ✕Clinically significant respiratory infection affecting asthma within 4 weeks prior to Visit 2
- ✕Oral, rectal, or parenteral systemic corticosteroids within 4 weeks prior to Visit 2
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating Budesonide and Pulmicort Turbuhaler for Asthma. Completed, enrolled 108 participants across 6 sites.
Detailed Summary
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.
Study Details
Timeline
Interventions
Inhalation powder, inhalation, twice daily, 4 weeks followed by Suspension for nebulisation, inhalation, once or twice daily, 6 weeks
Pulmicort Turbuhaler 200 µg, Dry powder inhaler, budesonide 200 µg/dose, 112 doses/Turbuhaler