Investigation to Identify Predictors of Response to a Treatment With Montelukast - Full Text View

Sponsor:	Marien Hospital Wesel
Collaborator:	Merck
Information provided by:	Marien Hospital Wesel
ClinicalTrials.gov Identifier:	NCT00721240

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 IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Placebo Control, Single Group Assignment, Pharmacokinetics/Dynamics Study
Official Title:	Investigation to Identify Predictors of Response to a Treatment With Montelukast

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Montelukast sodium Montelukast

U.S. FDA Resources

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
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
single-arm: Experimental This investigation is a single-center, two-phase, single-arm study. In order to detect a poten¬tial 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

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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

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

Contacts

Contact: Andrea von Berg, MD	0049-281-104-1179	vonberg@marien-hospital-wesel.de
Contact: Christina Bollrath, MD	0049-281-104-1659	forschung1@marien-hospital-wesel.de

Locations

Germany, NRW
Marien Hospital Wesel gGmbH	Recruiting
Wesel, NRW, Germany, 46483
Contact: ANDREA VON BERG, MD 00492811041179 vonberg@marien-hospital-wesel.de
Contact: Christina Bollrath, MD 00492811041659 forschung1@marien-hospital-wesel.de
Principal Investigator: Andrea von Berg, MD

Sponsors and Collaborators

Marien Hospital Wesel

Merck

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:	Marien Hospital Wesel, Forschungsinstitut zur Prävention von Allergien und Atemwegserkrankungen im Kindesalter an der Klinik für Kinder- und Jugendmedizin ( Dr. Andrea von Berg )
Study ID Numbers:	Trial No. 25.08.2005
Study First Received:	July 22, 2008
Last Updated:	July 24, 2008
ClinicalTrials.gov Identifier:	NCT00721240 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Marien Hospital Wesel:

responder
leucotriene antagonist

Additional relevant MeSH terms:

Montelukast
Respiratory System Agents
Therapeutic Uses
Hormone Antagonists
Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents
Pharmacologic Actions
Leukotriene Antagonists

ClinicalTrials.gov processed this record on February 08, 2010