Investigation to Identify Predictors of Response to a Treatment With Montelukast

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
Marien Hospital Wesel
ClinicalTrials.gov Identifier:
NCT00721240
First received: July 22, 2008
Last updated: February 16, 2010
Last verified: July 2008
  Purpose

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 Intervention Phase
Asthma
Drug: montelukast
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Investigation to Identify Predictors of Response to a Treatment With Montelukast

Resource links provided by NLM:


Further study details as provided by Marien Hospital Wesel:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • symptom score, PEAK-Flow, rescue medication, exhaled NO [ Time Frame: 2 weeks after run in and 14 weeks after run in ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: February 2006
Study Completion Date: June 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00721240

Locations
Germany
Marien Hospital Wesel gGmbH
Wesel, NRW, Germany, 46483
Sponsors and Collaborators
Marien Hospital Wesel
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: ANDREA VON BERG, MD Marien Hospital Wesel; FORSCHUNGSINSTITUT ZUR PRÄVENTION VON ALLERGIEN UND ATEMWEGSERKRANKUNGEN IM KINDESALTER AN DER kLINIK FÜR KINDER UND JUGENDMEDIZIN
  More Information

No publications provided

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
Study First Received: July 22, 2008
Last Updated: February 16, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Marien Hospital Wesel:
responder
leucotriene antagonist

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Montelukast
Leukotriene Antagonists
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014