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

Johann Wolfgang Goethe University Hospital

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: Montelukast; Drug: Fluticasone

Study type: Interventional

Funder types: Other

Identifiers

NCT00543686

165/07/FFM

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 4 to 6 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

1

Active Comparator group

Description:

Montelukast

Treatment:

Drug: Montelukast

2

Active Comparator group

Description:

Fluticasone

Treatment:

Drug: Fluticasone