Leukotriene Receptor Antagonists or Steroids in Pre-School Asthma

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00543686

Acronym

LOS

Enrollment

100

Registered

2007-10-15

Start date

2007-08-31

Completion date

2009-02-28

Last updated

2009-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Keywords

Pre-School Asthma, Responder Profiles, Fluticasone, Montelukast, Leukotriene, Children with Pre-School Asthma

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.

Interventions

DRUGMontelukast

Intake of Montelukast

DRUGFluticasone

Intake of Fluticasone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

4 Years to 6 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026