Montelukast as a Controller of Atopic Syndrome (MONTAS)

University of Helsinki

Status and phase: Completed; Phase 4

Conditions: Asthma; Allergic Conjunctivitis; Atopic Eczema; Seasonal Allergic Rhinitis

Treatments: Drug: montelukast

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00559546

HUS7/E5/07

Details and patient eligibility

About

The purpose of the study is to find out if montelukast can be used to treat the various symptoms of allergic syndrome.

Enrollment: 61 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Wheal diameter at least 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:

  • Allergic conjunctivitis
  • Atopic eczema
  • Oral symptoms from vegetables or fruits by cross reactivity to birch
  • Urticaria in allergen exposure

Exclusion criteria

• Need for regular treatment with glucocorticoids
• Current smoking
• Other major disease or need for regular drug treatment
• Pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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61 participants in 2 patient groups

1

Active Comparator group

Description:

3 weeks of Montelukast and 3 weeks of placebo treatment

Treatment:

Drug: montelukast

2

Active Comparator group

Description:

3 weeks of placebo and 3 weeks of montelukast treatment

Treatment:

Drug: montelukast