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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

Study Interventions

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

Study Arms

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;

Study Status

Unknown status

Start Date: July 2010

Completed Date: February 2011

Phase: Phase 4

Type: Interventional

Design:

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

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01170429

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