Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Effect of Montelukast on the Airway Remodeling

This study has been completed.
Information provided by (Responsible Party):
Jinming Gao, Chinese Academy of Medical Sciences Identifier:
First received: June 11, 2008
Last updated: January 3, 2012
Last verified: January 2012
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
Drug: singular
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, 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 ]
    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 ]
    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
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


Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT00699062

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

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Jinming Gao, Professor of Pulmonary Medicine, Chinese Academy of Medical Sciences Identifier: NCT00699062     History of Changes
Other Study ID Numbers: JGao001
Merck-IISP001 ( Other Grant/Funding Number: MSD pharmaceutical )
Study First Received: June 11, 2008
Last Updated: January 3, 2012

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

Additional relevant MeSH terms:
Airway Remodeling
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Pathological Conditions, Anatomical
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action processed this record on April 28, 2017