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: 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

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,  

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

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