Leukotriene Receptor Antagonists or Steroids in Pre-School Asthma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-08-31

Study Completion Date

2009-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Montelukast

Group Type ACTIVE_COMPARATOR

Montelukast

Intervention Type DRUG

Intake of Montelukast

2

Fluticasone

Group Type ACTIVE_COMPARATOR

Fluticasone

Intervention Type DRUG

Intake of Fluticasone

Interventions

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Montelukast

Intake of Montelukast

Intervention Type DRUG

Fluticasone

Intake of Fluticasone

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

4 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No