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: May 27, 2009
Verified by: AstraZeneca, May 2009
Clinical Trial Phase: N/A | Start Date: April 2008
Overall Status: Completed
Estimated Enrollment: 914
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
Study Primary Completion Date: March 2009
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,
Additional Information
Information obtained from ClinicalTrials.gov on July 02, 2009
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
Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.