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

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”

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

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

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

Lead Investigator: AstraZeneca Industry

Overall Clinical Trial Officials and Contacts

Hong Jianguo, Professor Principal Investigator Shanghai Jiao Tong University Affiliated First People's Hospital,  

Information obtained from ClinicalTrials.gov on February 12, 2012

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