Effect of Montelukast on the Airway Remodeling
2 other identifiers
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 asthma
Started Jan 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2008
CompletedFirst Posted
Study publicly available on registry
June 17, 2008
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedJanuary 5, 2012
January 1, 2012
2 years
June 11, 2008
January 3, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate distal airway function using high-resolution CT and lung function test
To demonstrate that the correlation between non-invisive chest HRCT and lung function test in patients moderate-to-severe asthma
6 months
Secondary Outcomes (1)
Montelukast can bring additional benefit for lung function improvement in moderate to severe patients with asthma
6 months
Study Arms (2)
Placebo pill
PLACEBO COMPARATORThe patients allocated into this placebo comparator arm will receive inhale corticosteroid plus long-acting bronchodilator plus placebo for 6 months.
Singular pill
EXPERIMENTALThe patients in this placebo comparator arm will receive inhale corticosteroid plus long-acting bronchodilator and montelukast for 6 months
Interventions
The participants randomized into this arm will receive singular 10mg q.n. plus combine therapy with inhaled ICS+LABA
The participants allocated into this arm will receive placebo 10mg,q.n plus combine therapy with inhaled ICS+LABA
Eligibility Criteria
You may qualify if:
- forced expiratory volume in one second (FEV1) is at 60-80% predicted or less than 60% predicted
- clinical diagnosis of moderate-to-severe asthma.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Union Medical College Hospital
Beijing, 100730, China
Related Publications (6)
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. doi: 10.1164/rccm.200501-088OC. Epub 2005 Dec 30.
PMID: 16387808BACKGROUNDGono 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. doi: 10.1183/09031936.03.00085302.
PMID: 14680087BACKGROUNDMitsunobu 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. doi: 10.1183/09031936.03.00081702.
PMID: 12882459BACKGROUNDZeidler 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. doi: 10.1183/09031936.06.00005605.
PMID: 16452585BACKGROUNDKing GG, Muller NL, Pare 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. doi: 10.1164/ajrccm.159.3.9805064. No abstract available.
PMID: 10051284BACKGROUNDGao JM, Cai F, Peng M, Ma Y, Wang B. Montelukast improves air trapping, not airway remodeling, in patients with moderate-to-severe asthma: a pilot study. Chin Med J (Engl). 2013 Jun;126(12):2229-34.
PMID: 23786930DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jinming Gao, M.D., Ph.D.
Peking Union Medical College Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Pulmonary Medicine
Study Record Dates
First Submitted
June 11, 2008
First Posted
June 17, 2008
Study Start
January 1, 2010
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
January 5, 2012
Record last verified: 2012-01