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

Johann Wolfgang Goethe University Hospital1 site in 1 country100 target enrollmentAugust 2007

ConditionsAsthma

InterventionsMontelukast Fluticasone

DrugsMontelukast Fluticasone

Overview

Phase: Phase 2
Intervention: Montelukast
Conditions: Asthma
Sponsor: Johann Wolfgang Goethe University Hospital
Enrollment: 100
Locations: 1
Primary Endpoint: 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)
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2007

End Date

February 2009

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Johann Wolfgang Goethe University Hospital

Eligibility Criteria

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

Arms & Interventions

1

Montelukast

Intervention: Montelukast

2

Fluticasone

Intervention: Fluticasone

Outcomes

Primary Outcomes

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 Outcomes

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