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Completed

NCT Number: NCT00559546

Montelukast as a Controller of Atopic Syndrome

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

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Key information

Conditions

Seasonal Allergic Rhinitis Allergic Conjunctivitis Asthma Atopic Eczema Bronchial Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Conjunctival Diseases Conjunctivitis Conjunctivitis, Allergic Dermatitis Dermatitis, Atopic Eye Diseases Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Skin and Allergy Hospital, Helsinki University Hospital

Helsinki, 00029 HUS, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Montelukast

Drug

10 mg montelukast tablet each evening for 3 weeks or placebo for 3 weeks in cross-over manner

Primary outcomes

  1. Allergic symptoms

    Time frame: 3 weeks

Secondary outcomes

  1. Need for antihistamines or inhaled beta-2-agonists to relieve symptoms

    Time frame: 3 weeks

  2. Exhaled nitric oxide concentration

    Time frame: 3 weeks

Sponsors and collaborators

Lead sponsor

University of Helsinki

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Acronym: MONTAS

Important dates

Study start
2007
Study completion
2007
First posted
Nov 16, 2007
Registry last updated
Nov 16, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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