Study to Evaluate Efficacy and Safety of Pulmicort Respules in Japanese Adult Asthmatic Patients
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: Pulmicort Respules (Drug); Pulmicort Turbuhaler (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Lars-Göran Carlsson, MD, Study Director, Affiliation: AstraZeneca R&D Lund
Overall contact:
AstraZeneca Clinical Study Information, Phone: 1-800-236-9933, Email: information.center@astrazeneca.com
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.
Clinical Details
Official title: 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)
Study design: Treatment, Non-Randomized, Open Label, Parallel Assignment, Efficacy Study
Primary outcome: PEF (mPEF)
Secondary outcome: PEF (ePEF), Asthma symptom score - day, night and total, Use of rescue medication - day, night and total, Nighttime awakenings due to asthma symptomsForced expiratory volume in one second (FEV1.0), Forced vital capacity (FVC)
Eligibility
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
AstraZeneca Clinical Study Information, Phone: 1-800-236-9933, Email: information.center@astrazeneca.com
Research Site, Ichikawa, Chiba, Japan; Recruiting
Research Site, Yokosuka, Kanagawa, Japan; Recruiting
Research Site, Tachikawa, Tokyo, Japan; Not yet recruiting
Research City, Hino, Tokyo, Japan; Recruiting
Research Site, Chiyoda, Tokyo, Japan; Active, not recruiting
Research Site, Setagaya, Tokyo, Japan; Not yet recruiting
Additional Information
Starting date: February 2009
Ending date: August 2009
Last updated: March 4, 2009
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