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Completed

NCT Number: NCT00543686

Leukotriene Receptor Antagonists or Steroids in Pre-School Asthma

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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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

4 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Goethe University, Department of Pulmonology

Frankfurt am Main, Hesse, 60590, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Montelukast

Drug

Intake of Montelukast

Fluticasone

Drug

Intake of Fluticasone

Primary outcomes

  1. 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

  1. 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

Sponsors and collaborators

Lead sponsor

Johann Wolfgang Goethe University Hospital

Other

Registry information

Official study title

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

Acronym: LOS

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Oct 15, 2007
Registry last updated
Feb 4, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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