Clinical trial NCT00660114: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cough Variant Asthma
Keywords: Cough variant asthma
Pulmicort® Respules®
Chinese patient Eligibility
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-04-17
Enrollment: 914
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient aged 5-year old or younger who has been diagnosed as cough variant asthma and decided by physician to use Pulmicort® Respules® inhalation.

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


Eligibility criteria: 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

Primary outcomes:
measure: Patient Symptom Score
timeFrame: 7 weeks (plus or minus 3 days )
Secondary outcomes:
measure: Patient Compliance Report
timeFrame: 7 weeks (plus or minus 3 days )
measure: Investigator Assessment Report
timeFrame: 7 weeks (plus or minus 3 days )
Other outcomes:
Locations:
city: Hefei
country: China
facility: Research Site
state: Anhui
city: Beijing
country: China
facility: Research Site
state: Beijing
city: Chongqing
country: China
facility: Research Site
state: Chongqing
city: Quanzhou
country: China
facility: Research Site
state: Fujian
city: Xiamen
country: China
facility: Research Site
state: Fujian
city: Guangzhou
country: China
facility: Research Site
state: Guangdong
city: Shenzhen
country: China
facility: Research Site
state: Guangdong
city: Zhongshan
country: China
facility: Research Site
state: Guangdong
city: Shi Jiazhuang
country: China
facility: Research Site
state: Hebei
city: Harbin
country: China
facility: Research Site
state: Hei Longjiang
city: Zhengzhou
country: China
facility: Research Site
state: Henan
city: Wuhan
country: China
facility: Research Site
state: Hubei
city: Changsha
country: China
facility: Research Site
state: Hunan
city: Changzhou
country: China
facility: Research Site
state: Jiangsu
city: Nanjing
country: China
facility: Research Site
state: Jiangsu
city: Suzhou
country: China
facility: Research Site
state: Jiangsu
city: Wuxi
country: China
facility: Research Site
state: Jiangsu
city: Nanchang
country: China
facility: Research Site
state: Jiangxi
city: Changchun
country: China
facility: Research Site
state: Jilin
city: Shenyang
country: China
facility: Research Site
state: Liaoning
city: Jinan
country: China
facility: Research Site
state: Shandong
city: Qingdao
country: China
facility: Research Site
state: Shandong
city: Shanghai
country: China
facility: Research Site
state: Shanghai
city: Taiyuan
country: China
facility: Research Site
state: Shanxi
city: Xi'an
country: China
facility: Research Site
state: Shanxi
city: Chengdu
country: China
facility: Research Site
state: Sichuan
city: Tianjin
country: China
facility: Research Site
state: Tianjin
city: Kunming
country: China
facility: Research Site
state: Yunnan
city: Hangzhou
country: China
facility: Research Site
state: Zhejiang
city: Ningbo
country: China
facility: Research Site
state: Zhejiang
city: Rui'an
country: China
facility: Research Site
state: Zhejiang
city: Wenzhou
country: China
facility: Research Site
state: Zhejiang
Study officials:
affiliation: Shanghai Jiao Tong University Affiliated First People's Hospital
name: Hong Jianguo, Professor
role: PRINCIPAL_INVESTIGATOR
References: