Efficacy and Safety Study of Procaterol Hydrochloride to Treat Patients With Cough Variant Asthma (CVA)

NCT01170429 | Unknown Phase 4 DMC

• 1 other identifier: 002-ZOC-0902i
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Cough Variant Asthma

Keywords

Cough Variant Asthma; Procaterol Hydrochloride

Outcome Measures

Primary Outcomes (3)

• Patient cough symptom score

  8 weeks

• Therapy duration

  8 weeks

• Rates of adverse events

  8 weeks

Secondary Outcomes (1)

• LCQ Life Quality Score

  8 weeks

Study Arms (2)

I. Procaterol Hydrochloride

EXPERIMENTAL

Meptin (Procaterol hydrochloride) Tablets, 25µg twice daily orally plus inhaled budesonide 200µg twice daily for eight weeks;

Drug: Procaterol hydrochloride

II. Procaterol hydrochloride placebo

PLACEBO COMPARATOR

Meptin placebo (Procaterol hydrochloride) Tablets, 25µg twice daily orally plus inhaled budesonide 200µg twice daily for eight weeks;

Drug: Meptin placebo

Interventions

Procaterol hydrochloride DRUG

25µg BID for 8 weeks

Also known as: Meptin

I. Procaterol Hydrochloride

Meptin placebo DRUG

25µg BID for 8 weeks

Also known as: Meptin

II. Procaterol hydrochloride placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Xin Zhou

Shanghai, Shanghai Municipality, 200080, China

Location

MeSH Terms

Conditions

Cough-Variant Asthma

Interventions

Procaterol

Condition Hierarchy (Ancestors)

Asthma; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Hydroxyquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Xin Zhou, MD

  Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xin Zhou

CONTACT

0086-21-63240090; xzhou53@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 23, 2010
• First Posted: July 27, 2010
• Study Start: July 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: July 27, 2010

Record last verified: 2010-06

Locations

CN (1)