Effect of Montelukast on the Airway Remodeling - Full Text View

Sponsor:	Chinese Academy of Medical Sciences
Information provided by (Responsible Party):	Jinming Gao, 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: singular Drug: placebo	Phase IV

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:

MedlinePlus related topics: Asthma

Drug Information available for: Montelukast sodium Montelukast

U.S. FDA Resources

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

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:

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:	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:

Asthma
Airway Remodeling
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

Pathological Conditions, Anatomical
Montelukast
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012