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Investigation to Identify Predictors of Response to a Treatment With Montelukast

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ClinicalTrials.gov Identifier: NCT00721240
Recruitment Status : Completed
First Posted : July 24, 2008
Last Update Posted : February 17, 2010
Merck Sharp & Dohme Corp.
Information provided by:
Marien Hospital Wesel

Brief Summary:
The main aim of the study is to develop a method that allows responders to be distinguished from non-responders before long-term treatment is initiated. Subsidiary aims are to record changes in pulmonary functional parameters, NO concentrations and peak flow variability, the use of beta2 sympathomimetics and the asthma symptom score.

Condition or disease Intervention/treatment Phase
Asthma Drug: montelukast Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigation to Identify Predictors of Response to a Treatment With Montelukast
Study Start Date : February 2006
Primary Completion Date : December 2008
Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Montelukast
U.S. FDA Resources

Arm Intervention/treatment
Experimental: single-arm
This investigation is a single-center, two-phase, single-arm study. In order to detect a potential placebo effect, the treatment phase will be preceded by a single-blinded two-week placebo run-in phase, followed by a 12 week open-label treatment phase.
Drug: montelukast
5mg montelukast once daily for 12 weeks
Other Name: Singulair ; MK-476

Primary Outcome Measures :
  1. Patients who show a bronchospasmolytic effect in their functional pulmonary test (FEV1 increased by at least 5%) within four hours of taking montelukast. [ Time Frame: 14 days after run in ]

Secondary Outcome Measures :
  1. symptom score, PEAK-Flow, rescue medication, exhaled NO [ Time Frame: 2 weeks after run in and 14 weeks after run in ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Children and adolescents with symptomatic bronchial asthma despite ongoing therapy
  • Age 6-14 years
  • Asthma diagnosed at lease six months previously (by a special pulmonary allergologic outpatient unit)
  • Demonstration of reversibility (FEV1 increased by at least 12% after bronchospasmolysis with a beta2 sympathomimetic). This can be determined at the screening visit or within the previous three months.
  • Patients who are either steroid-naive or who received constant doses of the following medi¬cations within the previous four weeks:

    • Beclomethasone dipropionate: up to 400 µg daily
    • Fluticasone propionate: up to 200 µg daily
    • Budesonide: up to 400 µg daily
  • Patients who are able to reliably complete the asthma diary and perform peak flow measurements according to instructions.
  • Girls of childbearing potential must have acceptable methods of contraceptions, including sexual abstinence.

Exclusion Criteria:

  • Patients who were treated with systemic steroids within the previous 30 days
  • Patients using one of the following asthma medications:

    • Systemic steroids
    • Nedocromil, DNCG
    • Theophylline
    • Ketotifen
    • Systemic or long-acting beta2 sympathomimetics
  • Patients who have experienced one of the following events within the previous 30 days:

    • A change in asthma medication
    • Pulmonary infection
    • Hospitalization due to bronchial asthma or any other respiratory condition
  • Patients who are currently participating in another clinical trial or have done so within the previous 30 days.
  • Patients known or expected to react hypersensitively to components of the investigational medication
  • Patients receiving Phenobarbital, Phenytoin, Rifampicin (medications that are metabolized by Cytochrom P450
  • Patients with analgetic intolerance
  • Pregnant females

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): NCT00721240

Marien Hospital Wesel gGmbH
Wesel, NRW, Germany, 46483
Sponsors and Collaborators
Marien Hospital Wesel
Merck Sharp & Dohme Corp.

Responsible Party: Dr. Andrea von Berg, Marien Hospital Wesel, Forschungsinstitut zur Prävention von Allergien und Atemwegserkrankungen im Kindesalter an der Klinik für Kinder- und Jugendmedizin
ClinicalTrials.gov Identifier: NCT00721240     History of Changes
Other Study ID Numbers: Trial No. 25.08.2005
First Posted: July 24, 2008    Key Record Dates
Last Update Posted: February 17, 2010
Last Verified: July 2008

Keywords provided by Marien Hospital Wesel:
leucotriene antagonist

Additional relevant MeSH terms:
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
Molecular Mechanisms of Pharmacological Action