Non-Interventional Study of Cough Variant Asthma Treatment With Pulmicort®Respules® in Children Outpatients
PUL NIS
A Non-Interventional Study of Cough Variant Asthma Treatment With Pulmicort®Respules® in Patient Aged 5-Year Old or Younger in Outpatient Department
1 other identifier
observational
914
1 country
32
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2008
Shorter than P25 for all trials
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
April 15, 2008
CompletedFirst Posted
Study publicly available on registry
April 17, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedMay 28, 2009
May 1, 2009
11 months
April 15, 2008
May 27, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient Symptom Score
7 weeks (plus or minus 3 days )
Secondary Outcomes (2)
Patient Compliance Report
7 weeks (plus or minus 3 days )
Investigator Assessment Report
7 weeks (plus or minus 3 days )
Eligibility Criteria
Patient aged 5-year old or younger who has been diagnosed as cough variant asthma and decided by physician to use Pulmicort® Respules® inhalation.
You may qualify if:
- Provision of informed consent
- The usage of Pulmicort® Respules® follows local authorised package insert.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (32)
Research Site
Hefei, Anhui, China
Research Site
Beijing, Beijing Municipality, China
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Chongqing, Chongqing Municipality, China
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Quanzhou, Fujian, China
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Xiamen, Fujian, China
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Guangzhou, Guangdong, China
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Shenzhen, Guangdong, China
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Zhongshan, Guangdong, China
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Shijiazhuang, Hebei, China
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Harbin, Hei Longjiang, China
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Zhengzhou, Henan, China
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Wuhan, Hubei, China
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Changsha, Hunan, China
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Changzhou, Jiangsu, China
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Nanjing, Jiangsu, China
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Suzhou, Jiangsu, China
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Wuxi, Jiangsu, China
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Nanchang, Jiangxi, China
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Changchun, Jilin, China
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Shenyang, Liaoning, China
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Jinan, Shandong, China
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Qingdao, Shandong, China
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Shanghai, Shanghai Municipality, China
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Taiyuan, Shanxi, China
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Xi’an, Shanxi, China
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Chengdu, Sichuan, China
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Tianjin, Tianjin Municipality, China
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Kunming, Yunnan, China
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Hangzhou, Zhejiang, China
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Ningbo, Zhejiang, China
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Rui’an, Zhejiang, China
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Wenzhou, Zhejiang, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hong Jianguo, Professor
Shanghai Jiao Tong University Affiliated First People's Hospital
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 15, 2008
First Posted
April 17, 2008
Study Start
April 1, 2008
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
May 28, 2009
Record last verified: 2009-05