Non-Interventional Study of Cough Variant Asthma Treatment With Pulmicort®Respules® in Children Outpatients

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

Secondary Measures

  • Patient Compliance Report
    • Time Frame: 7 weeks (plus or minus 3 days )
      Safety Issue?: No
  • Investigator Assessment Report
    • Time Frame: 7 weeks (plus or minus 3 days )
      Safety Issue?: No

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

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.