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

Cough Variant Asthma Clinical Trial

— PUL NIS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00660114
• Other study ID #: NIS-RCN-PUL-2008/1
• Status: Completed
• Phase: N/A
• First received: April 15, 2008
• Last updated: May 27, 2009
• Start date: April 2008
• Est. completion date: March 2009

Study information

• Verified date: May 2009
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 914
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 5 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Asthma
• Cough
• Cough Variant Asthma

Locations

Country	Name	City	State
China	Research Site	Beijing	Beijing
China	Research Site	Changchun	Jilin
China	Research Site	Changsha	Hunan
China	Research Site	Changzhou	Jiangsu
China	Research Site	Chengdu	Sichuan
China	Research Site	Chongqing	Chongqing
China	Research Site	Guangzhou	Guangdong
China	Research Site	Hangzhou	Zhejiang
China	Research Site	Harbin	Hei Longjiang
China	Research Site	Hefei	Anhui
China	Research Site	Jinan	Shandong
China	Research Site	Kunming	Yunnan
China	Research Site	Nanchang	Jiangxi
China	Research Site	Nanjing	Jiangsu
China	Research Site	Ningbo	Zhejiang
China	Research Site	Qingdao	Shandong
China	Research Site	Quanzhou	Fujian
China	Research Site	Rui'an	Zhejiang
China	Research Site	Shanghai	Shanghai
China	Research Site	Shenyang	Liaoning
China	Research Site	Shenzhen	Guangdong
China	Research Site	Shi Jiazhuang	Hebei
China	Research Site	Suzhou	Jiangsu
China	Research Site	Taiyuan	Shanxi
China	Research Site	Tianjin	Tianjin
China	Research Site	Wenzhou	Zhejiang
China	Research Site	Wuhan	Hubei
China	Research Site	Wuxi	Jiangsu
China	Research Site	Xi'an	Shanxi
China	Research Site	Xiamen	Fujian
China	Research Site	Zhengzhou	Henan
China	Research Site	Zhongshan	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Symptom Score		7 weeks (plus or minus 3 days )	No
Secondary	Patient Compliance Report		7 weeks (plus or minus 3 days )	No
Secondary	Investigator Assessment Report		7 weeks (plus or minus 3 days )	No