Cough Variant Asthma | Efficacy and Safety Study of Procaterol Hydrochloride to Treat Patients With Cough Variant Asthma (CVA)
Cough Variant Asthma research study
What is the primary objective of this study?
The purpose of this study is to investigate the efficacy and safety of procaterol hydrochloride with inhaled glucocorticoid in treatment patients with cough variant asthma (CVA).
Who is eligible to participate?
Inclusion Criteria: - male or female patients,18-75 years old; - 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 with chronic pulmonary disease; - 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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Cough Variant Asthma
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:Procaterol hydrochloride25µg BID for 8 weeks
Drug:Meptin placebo25µg BID for 8 weeks
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
I. Procaterol HydrochlorideMeptin (Procaterol hydrochloride) Tablets, 25µg twice daily orally plus inhaled budesonide 200µg twice daily for eight weeks;
II. Procaterol hydrochloride placeboMeptin placebo (Procaterol hydrochloride) Tablets, 25µg twice daily orally plus inhaled budesonide 200µg twice daily for eight weeks;
Start Date: July 2010
Completed Date: February 2011
Phase: Phase 4
Primary Outcome: Patient cough symptom score
Secondary Outcome: LCQ Life Quality Score
Study sponsors, principal investigator, and references
Principal Investigator: Xin Zhou, MD
Lead Sponsor: Shanghai Jiao Tong University School of Medicine