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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

July 23, 2010
July 26, 2010
July 2010
February 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01170429 on ClinicalTrials.gov Archive Site
LCQ Life Quality Score [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety Study of Procaterol Hydrochloride to Treat Patients With Cough Variant Asthma (CVA)
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)

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).

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Cough Variant Asthma
  • Drug: Procaterol hydrochloride
    25µg BID for 8 weeks
    Other Name: Meptin
  • Drug: Meptin placebo
    25µg BID for 8 weeks
    Other Name: Meptin
  • Experimental: I. Procaterol Hydrochloride
    Meptin (Procaterol hydrochloride) Tablets, 25µg twice daily orally plus inhaled budesonide 200µg twice daily for eight weeks;
    Intervention: Drug: Procaterol hydrochloride
  • Placebo Comparator: II. Procaterol hydrochloride placebo
    Meptin placebo (Procaterol hydrochloride) Tablets, 25µg twice daily orally plus inhaled budesonide 200µg twice daily for eight weeks;
    Intervention: Drug: Meptin placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
160
February 2011
February 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 75 Years
No
Contact: Xin Zhou 0086-21-63240090 ext 3142 xzhou53@163.com
China
 
NCT01170429
002-ZOC-0902i
Yes
Xin Zhou/Director of Respiratory Department, Shanghai Jiao Tong University Affiliated 1st People's Hospital
Shanghai Jiao Tong University School of Medicine
Not Provided
Principal Investigator: Xin Zhou, MD Shanghai Jiao Tong University School of Medicine
Shanghai Jiao Tong University School of Medicine
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP