Effects of Su-Huang Antitussive Capsule on Cough Variant Asthma

NCT01584804 | Unknown Phase 4 DMC

• 1 other identifier: 2003L03253
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to observe the therapeutic effect of Su-Huang antitussive capsule on cough variant asthma. The investigators hypothesize: Cough score and cough reflex sensitivity will be improved after treatment with Su-Huang antitussive capsule.

Conditions

Asthma

Keywords

Su Huang antitussive capsule; Cough variant asthma; Placebo

Outcome Measures

Primary Outcomes (1)

• Day-time and night-time cough symptom total-score changes from baseline to visit 3

  2 weeks

Secondary Outcomes (1)

• Cough reflex sensitivity changes in 2 groups at baseline and visit 3. Cell differential changes in hypertonic saline induced sputum in 2 groups at baseline and visit3.

  2 weeks

Study Arms (2)

Monotherapy

ACTIVE COMPARATOR

Monotherapy with Su-Huang antitussive capsule

Drug: Su-Huang antitussive capsule

Sugar pill

PLACEBO COMPARATOR

Monotherapy with placebo

Drug: Sugar pill

Interventions

Su-Huang antitussive capsule DRUG

Su-Huang antitussive capsule (0.45g) 3 capsules Tid for 2 weeks (swallowed by warm water at 0.5-1h after each meal)

Monotherapy

Sugar pill DRUG

Sugar pill 3 capsules Tid for 2 weeks (swallowed by warm water at 0.5-1h after each meal)

Sugar pill

Eligibility Criteria

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

You may qualify if:

• Patients who have a history of cough as sole or main symptom lasting more than 8 weeks, often irritating cough more cough at night.
• Patients who were diagnosed with positive result in bronchial provocation test by methacholine inhalation challenge.
• There is evidence that bronchodilator treatment\* is efficient for cough symptom (symptom score improved 1 at least).
• Patients whose chest x-ray outcome was normal or without any active focus.
• Patients who was aged from 18 years old (≥ 18 years old ) to 65 years old (≤ 75 years old).

You may not qualify if:

• Patients demonstrate FEV1/FVC \<70% in lung function test. FEV1 stands for forced expiratory volume in 1 second, FVC stands for forced vital capacity.
• Patients who is a smoker or ex-smoker and has smoked within the previous year or has a cumulative smoking history \>10 pack-years or equivalence.
• Patients with concomitance of GERC (gastroesophageal reflux-related chronic cough), chronic bronchitis , bronchiectasis, bronchial tuberculosis, ACEI induced cough, bronchogenic carcinoma, psychologic cough, pulmonary fibrosis, bronchus foreign body, microlithiasis, tracheobroncheopathia osteochondroplastica, mediastinal tumor, left ventricular dysfunction.
• Female subjects who are pregnant, breast-feeding or risk of becoming pregnant during the study.
• Subjects who are known or suspected to be hypersensitive to any component of the study medication or relief medications.
• Subjects who have received any therapy in the previous seven days, e.g. long-acting β2 agonist, theophylline sustained release.
• Subjects who have received oral/ inhaled/systematic corticosteroid in the previous 4 weeks.
• Subjects who are diagnosed with past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, haematological disease, neurological disease, endocrine disease or pulmonary disease. e.g.nasal-sinus infection, lower respiratory tract infection, chronic bronchitis, emphysema, bronchiectasis, cystic fibrosis or bronchopulmonary dysplasia.
• Subjects who demonstrate significant abnormality on biochemistry, hematology, ECG.

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

Guangzhou Institute of Respiratory Disease

Guangzhou, Guangdong, 520120, China

RECRUITING

MeSH Terms

Conditions

Asthma; Cough-Variant Asthma

Interventions

Sugars

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Carbohydrates

Study Officials

• Mengfeng Li, MD

  Sun Yat-sen University

  STUDY CHAIR

Central Study Contacts

Kefang Lai, PhD

CONTACT

8620 83062893; klai@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
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: April 24, 2012
• First Posted: April 25, 2012
• Study Start: June 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: August 1, 2013
• Last Updated: November 19, 2012

Record last verified: 2012-11

Locations

CN (1)