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Montelukast as a Controller of Atopic Syndrome (MONTAS)

This study has been completed.
Merck Sharp & Dohme Corp.
Information provided by:
Helsinki University Identifier:
First received: November 15, 2007
Last updated: NA
Last verified: November 2007
History: No changes posted
The purpose of the study is to find out if montelukast can be used to treat the various symptoms of allergic syndrome.

Condition Intervention Phase
Seasonal Allergic Rhinitis
Allergic Conjunctivitis
Atopic Eczema
Drug: montelukast
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Montelukast as a Controller of Atopic Syndrome

Resource links provided by NLM:

Further study details as provided by Helsinki University:

Primary Outcome Measures:
  • Allergic symptoms [ Time Frame: 3 weeks ]

Secondary Outcome Measures:
  • Need for antihistamines or inhaled beta-2-agonists to relieve symptoms [ Time Frame: 3 weeks ]
  • Exhaled nitric oxide concentration [ Time Frame: 3 weeks ]

Enrollment: 61
Study Start Date: March 2007
Study Completion Date: July 2007
Arms Assigned Interventions
Active Comparator: 1
3 weeks of Montelukast and 3 weeks of placebo treatment
Drug: montelukast
10 mg montelukast tablet each evening for 3 weeks or placebo for 3 weeks in cross-over manner
Active Comparator: 2
3 weeks of placebo and 3 weeks of montelukast treatment
Drug: montelukast
10 mg montelukast tablet each evening for 3 weeks or placebo for 3 weeks in cross-over manner


Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00559546

Skin and Allergy Hospital, Helsinki University Hospital
Helsinki, Finland, 00029 HUS
Sponsors and Collaborators
Helsinki University
Merck Sharp & Dohme Corp.
Principal Investigator: Tari Haahtela, Professor Skin and Allergy Hospital, Helsinki University Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00559546     History of Changes
Other Study ID Numbers: HUS7/E5/07
Study First Received: November 15, 2007
Last Updated: November 15, 2007

Additional relevant MeSH terms:
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Conjunctivitis, Allergic
Dermatitis, Atopic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Conjunctival Diseases
Eye Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases
Skin Diseases, Eczematous
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers processed this record on April 28, 2017