Cough Variant AsthmaPUL NISNCT00660114
Non-Interventional Study of Cough Variant Asthma Treatment With Pulmicort®Respules® in Children Outpatients
An observational study of Cough Variant Asthma, run by AstraZeneca at 32 sites in China.
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 Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Cough Variant Asthma
- How many people
- 914 participants
- Where
- 32 sitesChina
- Study dates
- Apr 2008to Mar 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 5 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
China32 sites
Research Site
Beijing, Beijing Municipality
Research Site
Changchun, Jilin
Research Site
Changsha, Hunan
Research Site
Changzhou, Jiangsu
Research Site
Chengdu, Sichuan
Research Site
Chongqing, Chongqing Municipality
Research Site
Guangzhou, Guangdong
Research Site
Hangzhou, Zhejiang
Research Site
Harbin, Hei Longjiang
Research Site
Hefei, Anhui
Research Site
Jinan, Shandong
Research Site
Kunming, Yunnan
Research Site
Nanchang, Jiangxi
Research Site
Nanjing, Jiangsu
Research Site
Ningbo, Zhejiang
Research Site
Qingdao, Shandong
Research Site
Quanzhou, Fujian
Research Site
Rui’an, Zhejiang
Research Site
Shanghai, Shanghai Municipality
Research Site
Shenyang, Liaoning
Research Site
Shenzhen, Guangdong
Research Site
Shijiazhuang, Hebei
Research Site
Suzhou, Jiangsu
Research Site
Taiyuan, Shanxi
Research Site
Tianjin, Tianjin Municipality
Research Site
Wenzhou, Zhejiang
Research Site
Wuhan, Hubei
Research Site
Wuxi, Jiangsu
Research Site
Xi’an, Shanxi
Research Site
Xiamen, Fujian
Research Site
Zhengzhou, Henan
Research Site
Zhongshan, Guangdong
About this study
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
- Conditions
- Cough Variant Asthma
- Keywords
- Cough variant asthma, Pulmicort® Respules®, Chinese patient Eligibility
- Medical subject headings
- Cough-Variant Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Symptom Score
Measured: 7 weeks (plus or minus 3 days )
Secondary outcomes (2)
Patient Compliance Report
Measured: 7 weeks (plus or minus 3 days )
Investigator Assessment Report
Measured: 7 weeks (plus or minus 3 days )
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cough Variant AsthmaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 914 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Hong Jianguo, Professor, Principal investigator, Shanghai Jiao Tong University Affiliated First People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00660114
- Sponsor's protocol ID
- NIS-RCN-PUL-2008/1
- Acronym
- PUL NIS
- Status last verified
- May 2009
- First submitted
- 15 Apr 2008
- Last updated
- 28 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00660114
- Acronym / sponsor ID
- PUL NIS / NIS-RCN-PUL-2008/1
- Conditions
- Cough Variant Asthma
- Keywords
- Cough variant asthma, Pulmicort® Respules®, Chinese patient Eligibility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 914 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Apr 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 17 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient Symptom Score
Time frame: 7 weeks (plus or minus 3 days )
2 secondary outcomes
Patient Compliance Report
Time frame: 7 weeks (plus or minus 3 days )
Investigator Assessment Report
Time frame: 7 weeks (plus or minus 3 days )
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2009.
Related trials for Cough Variant Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hong Jianguo, Professor principal investigator
Shanghai Jiao Tong University Affiliated First People's Hospital
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cough Variant Asthma, run by AstraZeneca at 32 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Symptom Score (time frame: 7 weeks (plus or minus 3 days )). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2009.