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
Recruitment status was Not yet recruiting
Sponsor:
Shanghai Jiao Tong University School of Medicine
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
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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
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 Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Respiration Disorders Signs and Symptoms, Respiratory Signs and Symptoms Procaterol Bronchodilator Agents |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Sympathomimetics Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013