Efficacy and Safety Study of Procaterol Hydrochloride to Treat Patients With Cough Variant Asthma (CVA)
NCT ID: NCT01170429
Last Updated: 2010-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
160 participants
INTERVENTIONAL
2010-07-31
2011-02-28
Brief Summary
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Detailed Description
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During the screening period, eligible patients will be evaluated by cough symptom score and LCQ life quality score. After 4 and 8 weeks treatment, patients will be evaluated by cough symptom score and LCQ life quality score respectively. Adverse events will also be captured at every visit.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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I. Procaterol Hydrochloride
Meptin (Procaterol hydrochloride) Tablets, 25µg twice daily orally plus inhaled budesonide 200µg twice daily for eight weeks;
Procaterol hydrochloride
25µg BID for 8 weeks
II. Procaterol hydrochloride placebo
Meptin placebo (Procaterol hydrochloride) Tablets, 25µg twice daily orally plus inhaled budesonide 200µg twice daily for eight weeks;
Meptin placebo
25µg BID for 8 weeks
Interventions
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Procaterol hydrochloride
25µg BID for 8 weeks
Meptin placebo
25µg BID for 8 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* cough lasting over 3 weeks ; dry cough or with slight white mucous phlegm; cough is the main clinical symptom or the only symptom;
* without wheeze and fever;
* without the history of upper respiratory tract infection within recent two months; non-smoking or giving-up smoking for over two years;
* without rales from lung;
* no obvious abnormalities from chest X-ray;
* bronchial provocation test: positive.
Exclusion Criteria
* patients who are allergic to ß2 receptor agonist;
* patients taking ß2 receptor agonist for long time;
* severe heart, renal and hepatic disease;
* unable to comply with the protocol;
* pregnant, breast feeding, and childbearing potential women;
* patients improper to the trial according to the investigators' judgment.
18 Years
75 Years
ALL
No
Sponsors
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Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Shanghai Jiao Tong University Affiliated 1st People's Hospital
Principal Investigators
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Xin Zhou, MD
Role: PRINCIPAL_INVESTIGATOR
Shanghai Jiao Tong University School of Medicine
Locations
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Xin Zhou
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Other Identifiers
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002-ZOC-0902i
Identifier Type: -
Identifier Source: org_study_id
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