Effect of Montelukast on the Airway Remodeling - Full Text View

Sponsored by:	Chinese Academy of Medical Sciences
Information provided by:	Chinese Academy of Medical Sciences
ClinicalTrials.gov Identifier:	NCT00699062

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: leukotriene receptor antagonist (montelukast) Drug: placebo	Phase IV

MedlinePlus related topics: Asthma

Drug Information available for: Montelukast sodium Montelukast

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Effect of Montelukast on the Airway Remodeling in Asthma Patients: Physiological-Radiological Correlation

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

Primary Outcome Measures:

Montelukast can improve lung function including proximal and distal airways and reverse airway remodeling in moderate to severe patients with asthma. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

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: Yes ]

Estimated Enrollment:	40
Study Start Date:	October 2008
Estimated Study Completion Date:	April 2011
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
P: Placebo Comparator The patients in this placebo comparator arm will receive inhale corticosteroid plus long-acting bronchodilator and placebo for 6 months.	Drug: placebo placebo, 10mg, QN, 6 months
T: Experimental The patients in this placebo comparator arm will receive inhale corticosteroid plus long-acting bronchodilator and montelukast for 6 months	Drug: leukotriene receptor antagonist (montelukast) leukotriene receptor antagonist montelukast 10mg, QN, 6 months

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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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00699062

Contacts

Contact: Jinming Gao, M.D., Ph.D.	86-10-6529-5035	gjinming@yahoo.com
Contact: Lei Shu, M.D.	86-21-6391-5522 ext 567	shirleen_shu@merck.com

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

this website provides the updated information on the this study This link exits the ClinicalTrials.gov site

Publications:

Henderson WR Jr, Chiang GK, Tien YT, Chi EY. Reversal of allergen-induced airway remodeling by CysLT1 receptor blockade. Am J Respir Crit Care Med. 2006 Apr 1;173(7):718-28. Epub 2005 Dec 30.

Gono H, Fujimoto K, Kawakami S, Kubo K. Evaluation of airway wall thickness and air trapping by HRCT in asymptomatic asthma. Eur Respir J. 2003 Dec;22(6):965-71.

Mitsunobu F, Ashida K, Hosaki Y, Tsugeno H, Okamoto M, Nishida N, Nagata T, Takata S, Tanizaki Y. Decreased computed tomographic lung density during exacerbation of asthma. Eur Respir J. 2003 Jul;22(1):106-12.

Zeidler MR, Kleerup EC, Goldin JG, Kim HJ, Truong DA, Simmons MD, Sayre JW, Liu W, Elashoff R, Tashkin DP. Montelukast improves regional air-trapping due to small airways obstruction in asthma. Eur Respir J. 2006 Feb;27(2):307-15.

King GG, Müller NL, Paré PD. Evaluation of airways in obstructive pulmonary disease using high-resolution computed tomography. Am J Respir Crit Care Med. 1999 Mar;159(3):992-1004. Review. No abstract available.

Responsible Party:	Peking Union Medical College Hospital ( Jinming Gao )
Study ID Numbers:	JGao001, Merck-IISP001
Study First Received:	June 11, 2008
Last Updated:	June 16, 2008
ClinicalTrials.gov Identifier:	NCT00699062
Health Authority:	China: Ethics Committee

Keywords provided by Chinese Academy of Medical Sciences:

antileukotriene
small airway
airway remodeling
HRCT

Study placed in the following topic categories:

Montelukast
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases

Hypersensitivity, Immediate
Asthma
Leukotriene Antagonists
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Respiratory System Agents
Immune System Diseases
Bronchial Diseases
Therapeutic Uses
Hormone Antagonists

Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009