Leukotriene Receptor Antagonists or Steroids in Pre-School Asthma (LOS)

February 3, 2009 updated by: Johann Wolfgang Goethe University Hospital

A Randomised Controlled Open-Label Phase IV Mono Centre Study to Compare the Response Profiles of Montelukast Versus Fluticasone in Children With Pre-School Asthma

Explorative comparison of montelukast with inhaled steroids (fluticasone) to estimate responder profiles, in terms of symptom scores, rescue medication, increase of FEV1, in correlation to presence of allergy, bronchial hyperreactivity (PD20), exhaled NO, excretion of leukotrienes, response to RABA and laboratory parameters in patients with pre-school asthma i.e. asthma phenotypes.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Hessen
      • Frankfurt, Hessen, Germany, 60590
        • Goethe University, Department of Pulmonology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female patients age 4 -6 years
  • Diagnosis of mild intermittent bronchial asthma (Step I-II) in the past 6 - 12 months as stated by the investigator:
  • Use of inhaled beta-2-agonists < 1/week (max 3 puff /d)
  • Exacerbation-free interval > 4 weeks prior to visit 1
  • The written informed consent of parents after received written and oral information about the aim, purpose and risks of the study must be present

Exclusion Criteria:

  • Asthma severity ≥ Step 2
  • Severe concomitant diseases
  • Suspected non-compliance
  • age below 4 and age above 7 years
  • last study participation < 30 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2
Fluticasone
Intake of Fluticasone
Active Comparator: 1
Montelukast
Intake of Montelukast

What is the study measuring?

Primary Outcome Measures

Outcome Measure
The primary efficacy variable is the number of responders with a very good asthma symptom control defined as requiring no rapid acting beta agonist (RABA) between the 2. and 6th week of intervention (end of trial)

Secondary Outcome Measures

Outcome Measure
the number of patients requiring at least five times RABA between the 2. and 6th week, the number of patients with an increase of FEV1 7.5%, the symptom score, symptom free days, rescue medication, presence of allergy RAST > 2, concentration of eNO, PD20

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Stefan Zielen, Prof. Dr., Johann Wolfgang Goethe-University Frankfurt, Zentrum für Kinderheilkunde I, Haus 32, Abt. Pneumologie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2007

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

October 11, 2007

First Submitted That Met QC Criteria

October 12, 2007

First Posted (Estimate)

October 15, 2007

Study Record Updates

Last Update Posted (Estimate)

February 4, 2009

Last Update Submitted That Met QC Criteria

February 3, 2009

Last Verified

February 1, 2009

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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