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Effect of Montelukast on Remodelling Markers in Asthmatic Children (MORACH)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Universita di Verona
ClinicalTrials.gov Identifier:
NCT00875082
First received: April 2, 2009
Last updated: July 1, 2010
Last verified: July 2010
History of Changes
  Purpose

Airway smooth muscle cell layer thickening and sub epithelial fibrosis, key allergen-induced airway remodelling features not modulated by corticosteroids, are reversible by CysLT1 receptor blockade therapy in animals. No data are available, at the present, about the potential effect of LTs receptor antagonists on airway remodelling in asthmatic children.

In the present study, the investigators aim to assess whether the addition of montelukast to ICS in mild asthmatic children to inhibit the release of MMP-9, TIMP-1, MMP-12, MMP-9/TIMP1 ratio, procollagen type I C-terminal peptide (PICP) and TGF-beta in the airway fluid collected by induced sputum in asthmatic children. 30-40 atopic children with mild persistent asthma.

Children with asthma will be recruited and evaluated with a real life open label trial: they will be randomised into two groups at first visit (T1): 1) group A: in these patients montelukast tablets 5 mg and as needed beta agonist will be administered; 2) group B: in these patients beta agonist therapy only.

All children will be evaluated after 8 weeks (T2). They will be tested for lung function, FeNO, metalloproteinase (MMP)-9, MMP-12, tissue inhibitor metalloproteinase-1 (TIMP-1), procollagen type I C-terminal peptide (PICP) and TGF-beta1 levels in sputum.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Effect of Montelukast on Metalloproteinase (MMP)-9, MMP-12, Tissue Inhibitor Metalloproteinase-1 (TIMP-1), Procollagen Type I C-terminal Peptide (PICP) and TGF-beta1 Levels in Sputum From Mild Intermittent Asthmatic Children: a Pilot Study

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by Universita di Verona:

Primary Outcome Measures:
  • FeNo, Lung Function, MMP-9, MMP-12, TIMP-1, PICP and TGFB determination [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: February 2010
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Montelukast
Montelukast chewing tablets once daily per os, plus inhaled short acting beta2 agonist as needed
 Drug: Montelukast
Montelukast, chewing tablets 5mg, once daily, 8 weeks
Placebo Comparator: placebo
placebo chewing tablets per os once daily, plus inhaled short acting beta 2 agonist as needed
 Drug: placebo
placebo chewing tablets once daily, plus inhaled short acting beta2 agonist as needed, 8 weeks

  Eligibility

Ages Eligible for Study:   6 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnostic criteria: the classification of asthma will be based on clinical history and examination and pulmonary function parameters, according to international guidelines.
  • Stage and/or severity of condition: atopic children with mild intermittent asthma will be enrolled. Atopy will be evaluated by skin-prick test to common allergens in the area.
  • Confirmatory physical and laboratory findings:
  • Age: ranging in age 6 to 14 years.
  • Evidence of susceptibility to the disease under study
  • Patients have not used ICS during 3-month period prior to study entry

Exclusion Criteria:

  • Patients will be excluded if they had used oral steroids in the last month.
  • Patients will be excluded if they had acute or chronic lung diseases other than asthma, upper or lower airway infection in the previous 3 weeks or during the trial, acute asthma exacerbation, or had used oral steroids in the last month.
  • Patients will be excluded if they had acute or chronic lung diseases other than asthma, upper or lower airway infections in the previous 3 weeks or during the trial, acute asthma exacerbation, or had used oral steroids in the last month.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00875082

Locations
Italy
Pediatric Department, University of Verona
Verona, Italy, I-37134
Sponsors and Collaborators
Universita di Verona
Investigators
Principal Investigator: Attilio L Boner, MD Pediatric Department, Università di Verona
  More Information

No publications provided

Responsible Party: Attilio L. Boner, MD, Università di Verona
ClinicalTrials.gov Identifier: NCT00875082     History of Changes
Other Study ID Numbers: UVAB-02
Study First Received: April 2, 2009
Last Updated: July 1, 2010
Health Authority: Italy: Ethics Committee

Keywords provided by Universita di Verona:
Asthma
Children
Remodelling
Metalloproteinases
Montelukast

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
 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 May 21, 2013