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Montelukast as a Controller of Atopic Syndrome (MONTAS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00559546
Recruitment Status : Completed
First Posted : November 16, 2007
Last Update Posted : November 16, 2007
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Helsinki University

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

Condition or disease Intervention/treatment Phase
Seasonal Allergic Rhinitis Allergic Conjunctivitis Atopic Eczema Asthma Drug: montelukast Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Montelukast as a Controller of Atopic Syndrome
Study Start Date : March 2007
Actual Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Montelukast

Arm Intervention/treatment
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




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

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00559546


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00559546    
Other Study ID Numbers: HUS7/E5/07
First Posted: November 16, 2007    Key Record Dates
Last Update Posted: November 16, 2007
Last Verified: November 2007
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Rhinitis, Allergic, Seasonal
Conjunctivitis
Conjunctivitis, Allergic
Dermatitis, Atopic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Dermatitis
Skin Diseases
Skin Diseases, Eczematous
Conjunctival Diseases
Eye Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Montelukast
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