Montelukast as a controller of atopic syndrome - MONTAS-study - MONTAS

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-000047-99-FI

Enrollment

Registered

2007-01-23

Start date

2007-03-06

Completion date

Unknown

Last updated

2018-06-05

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

Conditions

Allergic symptoms (rhinitis, conjunctivits, asthma, oral symptoms and atopic eczema) caused by pollen allergy to birch or timothy. MedDRA version: 20.0 Level: LLT Classification code 10001709 Term: Allergic conjunctivitis System Organ Class: 100000004853 MedDRA version: 20.0 Level: LLT Classification code 10003641 Term: Atopic eczema System Organ Class: 100000004858 MedDRA version: 20.0 Level: LLT Classification code 10001723 Term: Allergic rhinitis System Organ Class: 100000004855 MedDRA ve

Interventions

Trade Name: Singulair Pharmaceutical Form: Tablet INN or Proposed INN: MONTELUKAST SODIUM CAS Number: 151767021 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The inclusion criteria are: · 18 – 40 years of age · Wheal diameter over 4 mm in skin-prick test for both birch and timothy · Allergic symptoms in both upper airways (allergic rhinitis) and lower airways (asthma-like symptoms or diagnosed asthma) and at least one of the following: o Allergic conjunctivitis o Atopic eczema o Oral symptoms from vegetables or fruits by cross reactivity to birch o Urticaria in allergen exposure Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes 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: The exclusion criteria are: • Need for regular treatment with glucocorticoids • Current smoking • Other major disease or need for regular drug treatment o Cardiovascular diseases o Diabets o Rheumatic or other immunological diseases • Pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: To test if montelukast could be used as an easy systemic controller of various aspects of atopic syndrome (rhinitis, conjunctivitis, asthma, eczema, oral symptoms).;Secondary Objective: ;Primary end point(s): The main outcome parameter is allergic symptoms assessed with a written questionnaire.	—

Countries

Finland

Outcome results

None listed

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