Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Montelukast | Active Comparator | Montelukast chewing tablets once daily per os, plus inhaled short acting beta2 agonist as needed |
|
| placebo | Placebo Comparator | placebo chewing tablets per os once daily, plus inhaled short acting beta 2 agonist as needed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Montelukast | Drug | Montelukast, chewing tablets 5mg, once daily, 8 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| FeNo, Lung Function, MMP-9, MMP-12, TIMP-1, PICP and TGFB determination | 8 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Attilio L Boner, MD | Pediatric Department, Università di Verona | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatric Department, University of Verona | Verona | I-37134 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27657514 | Derived | Tenero L, Piazza M, Sandri M, Azzali A, Chinellato I, Peroni D, Boner A, Piacentini G. Effect of montelukast on markers of airway remodeling in children with asthma. Allergy Asthma Proc. 2016 Sep;37(5):77-83. doi: 10.2500/aap.2016.37.3978. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C093875 | montelukast |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo |
| Drug |
placebo chewing tablets once daily, plus inhaled short acting beta2 agonist as needed, 8 weeks |
|
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |