Study to Evaluate Efficacy and Safety of Pulmicort Respules in Japanese Adult Asthmatic Patients

• Status: Completed
• Trial end date: 2009-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Budesonide

Criteria

Inclusion Criteria:

• Provision of informed consent prior to any study specific procedures.

• A minimum of 6 months documented history of asthma according to the JGL 2006 definition

• Asthma patients under prescribed treatment with ICS at least 3 months before Visit 2.

Exclusion Criteria:

• Current or previous tobacco smokers with a history of >= 10 pack-years

• Use of β-blockers including eye drops

• Clinically significant respiratory infection affecting the asthma, as judged by the investigator(s) within 4 weeks prior to visit 2

• Intake of oral, rectal or parenteral GCS within 4 weeks prior to Visit 2