Investigation to Identify Predictors of Response to a Treatment With Montelukast

NCT00721240 | Completed Phase 4

• 1 other identifier: Trial No. 25.08.2005
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

responder; leucotriene antagonist

Outcome Measures

Primary Outcomes (1)

• Patients who show a bronchospasmolytic effect in their functional pulmonary test (FEV1 increased by at least 5%) within four hours of taking montelukast.

  14 days after run in

Secondary Outcomes (1)

• symptom score, PEAK-Flow, rescue medication, exhaled NO

  2 weeks after run in and 14 weeks after run in

Study Arms (1)

single-arm

EXPERIMENTAL

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

Interventions

montelukast DRUG

5mg montelukast once daily for 12 weeks

Also known as: Singulair ; MK-476

single-arm

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Marien Hospital Wesel: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Marien Hospital Wesel gGmbH

Wesel, North Rhine-Westphalia, 46483, Germany

Location

MeSH Terms

Conditions

Asthma

Interventions

montelukast

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• ANDREA VON BERG, MD

  Marien Hospital Wesel; FORSCHUNGSINSTITUT ZUR PRÄVENTION VON ALLERGIEN UND ATEMWEGSERKRANKUNGEN IM KINDESALTER AN DER kLINIK FÜR KINDER UND JUGENDMEDIZIN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 22, 2008
• First Posted: July 24, 2008
• Study Start: February 1, 2006
• Primary Completion: December 1, 2008
• Study Completion: June 1, 2009
• Last Updated: February 17, 2010

Record last verified: 2008-07

Locations

DE (1)