Randomized, double-blind, placebo controlled trial on the efficacy of montelukast in exercise-induced asthma in children - MONTEIA

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-004984-43-IT

Enrollment

Registered

2006-01-09

Start date

2005-11-14

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

exercise-induced asthma MedDRA version: 6.1 Level: PT Classification code 10003557

Interventions

Trade Name: SINGULAIR BB 28 CPR MAST.5MG Pharmaceutical Form: Capsule, soft INN or Proposed INN: Montelukast Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Phar

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: outpatients aged 6 to 14 years with a history of typical symptoms of exercise-induced asthma. pre-exercise FEV1 at least 75 of the predicted value 15 or greater decrease in FEV1 after a standardized treadmill exercise challenge Absence of farmacological treatment 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: Sensitivity to montelukast Singulair or its components. a pulmonary disease other than asthma or other cronic pathologies acute upper respiratory tract infection

Design outcomes

Primary

Measure	Time frame
Main Objective: maximal percentage fall in FEV1 from the baseline value;Primary end point(s): maximal percentage fall in FEV1 from the baseline value;Secondary Objective: maximal percentage fall in FEF25-75 from the baseline value percentage of protection calculated as Ps Pt/Ps, where Ps is the percentage fall in FEV1 at the screening test, and Pt is the percentage fall in FEV1 after each treatment percentage of positive and negative test in the group treated with montelukast correlation with the following conditions sex, exposure to sigarette smoke, bronchiliotis in the first year of life, family history of allergy.	—

Measure

Time frame

Main Objective: maximal percentage fall in FEV1 from the baseline value;Primary end point(s): maximal percentage fall in FEV1 from the baseline value;Secondary Objective: maximal percentage fall in FEF25-75 from the baseline value percentage of protection calculated as Ps Pt/Ps, where Ps is the percentage fall in FEV1 at the screening test, and Pt is the percentage fall in FEV1 after each treatment percentage of positive and negative test in the group treated with montelukast correlation with the following conditions sex, exposure to sigarette smoke, bronchiliotis in the first year of life, family history of allergy.

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Countries

Italy

Outcome results

None listed

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