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Effect of montelukast on levels of metalloproteinase-9 (MMP-9), MMP-12, tissue inhibitor metalloproteinase-1 (TIMP-1), procollagen peptide type 1 C-terminal (PICP) and TGF-beta1 on induced sputum of children suffering from intermittent asthma. - ND

Effect of montelukast on levels of metalloproteinase-9 (MMP-9), MMP-12, tissue inhibitor metalloproteinase-1 (TIMP-1), procollagen peptide type 1 C-terminal (PICP) and TGF-beta1 on induced sputum of children suffering from intermittent asthma. - ND

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2008-006373-33-IT
Enrollment
Unknown
Registered
2008-12-30
Start date
2009-02-11
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intermittent asthma MedDRA version: 9.1 Level: LLT Classification code 10003553 Term: Asthma

Interventions

Pharmaceutical Form: Chewable tablet INN or Proposed INN: Montelukast Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical Form: Pharmaceutical Form

Sponsors

AZIENDA OSPEDALIERA ISTITUTI OSPITALIERI DI VERONA
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Atopic children (6-14 years) with mild intermittent asthma Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Assumption of ICS in previous 3 months; acute exacerbations of bronchial asthma; pulmonar diseases other than asthma, high- or low-respiratory tract infection in previous 3 weeks.

Design outcomes

Primary

MeasureTime frame
Main Objective: To evaluate if 4-weeks treatment with montelukast in children affected by intermittent asthma can significantly reduce levels of TIMP-1 on induced sputum.;Secondary Objective: To analyse effect of treatment on other remodeling markers, associated to TIMP-1 activity, such as MMP-9, MMP-12, PICP and TGF-beta1, on induced sputum.;Primary end point(s): Reduction of TIMP-1 levels after treatment with montelukast.—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026