Effects of Leukotriene Modulator Montelukast on Cough Variant Asthma

NCT01404013 | Unknown Phase 4 DMC

• 1 other identifier: MISP 39227
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to observe the therapeutic effect of leukotriene modulator montelukast alone or combined with inhaled corticosteroid(ICS) on cough variant asthma(CVA). The investigators hypothesize:

1. 1.Cough score and cough reflex sensitivity will be improved after treatment with montelukast, inhaled corticosteroid/β2 agonist(ICS/LABA), and two combinations.
2. 2.Combination of leukotriene modulator and inhaled corticosteroid/β2 agonist may have better efficacy when compared to montelukast, corticosteroid/β2 agonist alone while MON, is comparable to symbicort.

Conditions

Asthma

Keywords

Montelukast; Cough variant asthma; Inhaled Corticosteroid

Outcome Measures

Primary Outcomes (1)

• Day-time and night-time cough symptom total-score changes from baseline to visit 4

  8 weeks

Secondary Outcomes (1)

• Cough reflex sensitivity changes in different groups at baseline, visit 2, visit3, and visit 4. Cell differential changes in hypertonic saline induced sputum in different groups at baseline, visit 2, visit3, and visit 4.

  8 weeks

Study Arms (3)

Montelukast

ACTIVE COMPARATOR

Monotherapy with Montelukast 10mg, take orally ,every night,for 8 weeks

Drug: Montelukast

ICS/LABA and Montelukast

ACTIVE COMPARATOR

Combination therapy with inhaled corticosteroid/β2 agonist 160/4.5ug,twice a day and Montelukast 10mg，take orally,every night for 8 weeks

Drug: ICS/LABA and Montelukast

ICS/LABA

ACTIVE COMPARATOR

Monotherapy with corticosteroid/β2 agonist 160/4.5ug,inhaled, twice a day, for 8 weeks

Drug: ICS/LABA

Interventions

ICS/LABA DRUG

Budesonide 160µg and Formoterol 4.5µg, 1puff ,twice a day, for 8 weeks

Also known as: Symbicort Turbuhaler

ICS/LABA

Montelukast DRUG

Montelukast 10mg ,every night, for 8 weeks

Also known as: Singulair

Montelukast

ICS/LABA and Montelukast DRUG

Budesonide 160µg and Formoterol 4.5µg, 1puff, twice a day, for 8 weeks; Montelukast 10mg ,take orally ,every night for 8 weeks

Also known as: Inhaled corticosteroid/β2 agonist: Symbicort Turbuhaler, Montelukast: Singulair

ICS/LABA and Montelukast

Eligibility Criteria

• Age: 18 Years - 75 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 75 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. oral/ inhaled/systematic corticosteroid, long-acting β2 agonist, theophylline sustained release.
• 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
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Guangzhou Institute of Respiratory Disease

Guangzhou, Guangdong, 520120, China

RECRUITING

Related Publications (1)

• Yi F, Zhan C, Liu B, Li H, Zhou J, Tang J, Peng W, Luo W, Chen Q, Lai K. Effects of treatment with montelukast alone, budesonide/formoterol alone and a combination of both in cough variant asthma. Respir Res. 2022 Oct 10;23(1):279. doi: 10.1186/s12931-022-02114-6.

  PMID: 36217131 DERIVED

MeSH Terms

Conditions

Asthma; Cough-Variant Asthma

Interventions

Budesonide, Formoterol Fumarate Drug Combination; montelukast

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Formoterol Fumarate; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Budesonide; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

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: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: July 26, 2011
• First Posted: July 27, 2011
• Study Start: February 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: July 14, 2014

Record last verified: 2012-11

Locations

CN (1)