Effect of Montelukast on the Airway Remodeling

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jinming Gao, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00699062
First received: June 11, 2008
Last updated: January 3, 2012
Last verified: January 2012
  Purpose

The distal lung contributes to asthmatic airway remodeling which is observed from early onset of the disease. Cysteinyl leukotrienes (CysLT) play important role in the pathogenesis of airway remodeling and antileukotrienes work to exert a certain degree of anti-inflammatory effect. The cysteinyl leukotriene antagonist Montelukast has been in vivo shown to significantly inhibit ovalbumin induced airway smooth muscle hyperplasia and subepithelial fibrosis in sensitized mice. This study aims to evaluate if Montelukast could reverse airway remodeling in asthma patients by a non-invasive approach-HRCT.


Condition Intervention Phase
Asthma
Drug: singular
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Montelukast on the Airway Remodeling in Asthma Patients: Physiological-radiological Correlation

Resource links provided by NLM:


Further study details as provided by Chinese Academy of Medical Sciences:

Primary Outcome Measures:
  • To evaluate distal airway function using high-resolution CT and lung function test [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To demonstrate that the correlation between non-invisive chest HRCT and lung function test in patients moderate-to-severe asthma


Secondary Outcome Measures:
  • Montelukast can bring additional benefit for lung function improvement in moderate to severe patients with asthma [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    To test whether montelukast can improve the distal airway function


Enrollment: 40
Study Start Date: January 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo pill
The patients allocated into this placebo comparator arm will receive inhale corticosteroid plus long-acting bronchodilator plus placebo for 6 months.
Drug: placebo
The participants allocated into this arm will receive placebo 10mg,q.n plus combine therapy with inhaled ICS+LABA
Other Name: placebo
Experimental: Singular pill
The patients in this placebo comparator arm will receive inhale corticosteroid plus long-acting bronchodilator and montelukast for 6 months
Drug: singular
The participants randomized into this arm will receive singular 10mg q.n. plus combine therapy with inhaled ICS+LABA
Other Name: montelukast

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • forced expiratory volume in one second (FEV1) is at 60-80% predicted or less than 60% predicted
  • clinical diagnosis of moderate-to-severe asthma.

Exclusion Criteria:

  • intravenous, oral or intramuscular steroids used within 1 months
  • Anti-leukotrienes, cromolyn sodium or nedocromil used within 2 months
  • Theophylline or beta-adrenergic blockers used within 1 month
  • Tobacco Used within the past year or cumulative smoking history > 5 pack-yrs
  • Respiratory infection or an influenza vaccination Within 3 weeks
  • Pregnant or lactating females
  • Patient has a history of an anaphylactic allergic reaction related to administration of either a marketed or investigational drug
  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: NCT00699062

Locations
China
Peking Union Medical College Hospital
Beijing, China, 100730
Sponsors and Collaborators
Chinese Academy of Medical Sciences
Investigators
Principal Investigator: Jinming Gao, M.D., Ph.D. Peking Union Medical College Hospital
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jinming Gao, Professor of Pulmonary Medicine, Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier: NCT00699062     History of Changes
Other Study ID Numbers: JGao001, Merck-IISP001
Study First Received: June 11, 2008
Last Updated: January 3, 2012
Health Authority: China: Ethics Committee

Keywords provided by Chinese Academy of Medical Sciences:
antileukotriene
small airway
airway remodeling
HRCT

Additional relevant MeSH terms:
Airway Remodeling
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Pathological Conditions, Anatomical
Respiratory Hypersensitivity
Respiratory Tract Diseases
Montelukast
Anti-Asthmatic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Leukotriene Antagonists
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014