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

Tracking Information

First Received Date ^ICMJE

April 15, 2008

Last Updated Date

May 27, 2009

Start Date ^ICMJE

April 2008

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Patient Symptom Score [ Time Frame: 7 weeks (plus or minus 3 days ) ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00660114 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Patient Compliance Report [ Time Frame: 7 weeks (plus or minus 3 days ) ] [ Designated as safety issue: No ]
Investigator Assessment Report [ Time Frame: 7 weeks (plus or minus 3 days ) ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Non-Interventional Study of Cough Variant Asthma Treatment With Pulmicort®Respules® in Patient Aged 5-Year Old or Younger in Outpatient Department

Brief Summary

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

Detailed Description

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Other, Prospective

Condition ^ICMJE

Cough Variant Asthma

Intervention ^ICMJE

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

914

Completion Date

March 2009

Primary Completion Date

March 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

up to 5 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

China

Administrative Information

NCT ID ^ICMJE

NCT00660114

Responsible Party

Lars-Göran Carlsson - Medical Science Director, AstraZeneca

Study ID Numbers ^ICMJE

NIS-RCN-PUL-2008/1

Study Sponsor ^ICMJE

AstraZeneca

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Hong Jianguo, Professor

Shanghai Jiao Tong University Affiliated First People's Hospital,

Information Provided By

AstraZeneca

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP