This open label, non-interventional study is to show the efficacy of Pulmicort®Respules® in cough variant asthma in patient aged 5-year old or younger in outpatient...
Date First Received: April 15, 2008
Last Updated: April 15, 2008
Verified by: AstraZeneca, April 2008
Clinical Trial Phase: N/A | Start Date: April 2008
Overall Status: Recruiting
Estimated Enrollment: 880
Brief Summary
Official Title: “A Non-Interventional Study of Cough Variant Asthma Treatment With Pulmicort®Respules® in Patient Aged 5-Year Old or Younger in Outpatient Department”
Condition Keyword(s):
This open label, non-interventional study is to show the efficacy of Pulmicort®Respules® in cough variant asthma in patient aged 5-year old or younger in outpatient department
Study Type: Observational
Study Design: Other, Prospective
Outcome Measures for this Clinical Trial
Primary Measures
- Patient Symptom Score
- Time Frame: 7 weeks (plus or minus 3 days )
Safety Issue?: No
- Time Frame: 7 weeks (plus or minus 3 days )
Secondary Measures
- Patient Compliance Report
- Time Frame: 7 weeks (plus or minus 3 days )
Safety Issue?: No
- Time Frame: 7 weeks (plus or minus 3 days )
- Investigator Assessment Report
- Time Frame: 7 weeks (plus or minus 3 days )
Safety Issue?: No
- Time Frame: 7 weeks (plus or minus 3 days )
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Provision of informed consent
- Patient who has been prescribed Pulmicort® Respules® according to physician's judgement, irrespective of the inclusion in the study.
- The usage of Pulmicort® Respules® follows local authorised package insert.
Exclusion Criteria:
- Allergy to any ingredient of Pulmicort® Respules®
- With history of Leukotriene Modifier (LM) usage prior to 2 weeks of recruitment or following plan.
- Have used systemic/inhaled steroid prior to 2 weeks of recruitment
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: N/A
Maximum Age for this Clinical Trial: 5 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: AstraZeneca
Overall Clinical Trial Officials and Contacts
Hong Jianguo, Professor Principal Investigator Shanghai Jiao Tong University Affiliated First People's Hospital,
Overall Contact: AstraZeneca China Clinical Study Information +8621 52564555 tracy.shi@AstraZeneca.com
Additional Information
Information obtained from ClinicalTrials.gov on September 04, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00660114
Study ID Number: NIS-RCN-PUL-2008/1
ClinicalTrials.gov Identifier: NCT00660114
Health Authority: China: State Food and Drug Administration
Clinical Trials Authorship and Review
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