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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Shanghai Jiao Tong University School of Medicine.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:
NCT01170429
First received: July 23, 2010
Last updated: July 26, 2010
Last verified: June 2010
  Purpose

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).


Condition Intervention Phase
Cough Variant Asthma
Drug: Procaterol hydrochloride
Drug: Meptin placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicentered, Double-blinded, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Procaterol Hydrochloride With Inhaled Glucocorticoid in Treatment Patients With Cough Variant Asthma (CVA)

Resource links provided by NLM:


Further study details as provided by Shanghai Jiao Tong University School of Medicine:

Primary Outcome Measures:
  • Patient cough symptom score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Therapy duration [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Rates of adverse events [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • LCQ Life Quality Score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 160
Study Start Date: July 2010
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I. Procaterol Hydrochloride
Meptin (Procaterol hydrochloride) Tablets, 25µg twice daily orally plus inhaled budesonide 200µg twice daily for eight weeks;
Drug: Procaterol hydrochloride
25µg BID for 8 weeks
Other Name: Meptin
Placebo Comparator: II. Procaterol hydrochloride placebo
Meptin placebo (Procaterol hydrochloride) Tablets, 25µg twice daily orally plus inhaled budesonide 200µg twice daily for eight weeks;
Drug: Meptin placebo
25µg BID for 8 weeks
Other Name: Meptin

Detailed Description:

This is a 8-week, double-blind, randomized, placebo-controlled study, the patients with CVA will be randomized to experimental or placebo control group.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01170429

Contacts
Contact: Xin Zhou 0086-21-63240090 ext 3142 xzhou53@163.com

Locations
China, Shanghai
Xin Zhou
Shanghai, Shanghai, China, 200080
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
Principal Investigator: Xin Zhou, MD Shanghai Jiao Tong University School of Medicine
  More Information

No publications provided

Responsible Party: Xin Zhou/Director of Respiratory Department, Shanghai Jiao Tong University Affiliated 1st People's Hospital
ClinicalTrials.gov Identifier: NCT01170429     History of Changes
Other Study ID Numbers: 002-ZOC-0902i
Study First Received: July 23, 2010
Last Updated: July 26, 2010
Health Authority: China: Food and Drug Administration

Keywords provided by Shanghai Jiao Tong University School of Medicine:
Cough Variant Asthma
Procaterol Hydrochloride

Additional relevant MeSH terms:
Asthma
Cough
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiration Disorders
Respiratory Hypersensitivity
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Procaterol
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sympathomimetics
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014