Leukotriene Receptor Antagonists or Steroids in Pre-School Asthma

Phase 2

Completed

• Conditions: Asthma
• Interventions: Drug: Montelukast; Drug: Fluticasone

• Registration Number: NCT00543686
• Lead Sponsor: Johann Wolfgang Goethe University Hospital

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-10-11
• Study First Submitted QC: 2007-10-12
• Study First Posted: 2007-10-15
• Primary Completion: 2009-01
• Status Verified: 2009-02
• Study Completion: 2009-02
• Last Update Submitted: 2009-02-03
• Last Update Posted: 2009-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Montelukast	Montelukast
2	Fluticasone	Fluticasone

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Goethe University, Department of Pulmonology; 🇩🇪 Frankfurt, Hessen, Germany