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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00543686
Recruitment Status : Completed
First Posted : October 15, 2007
Last Update Posted : February 4, 2009
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Montelukast Drug: Fluticasone Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : August 2007
Actual Primary Completion Date : January 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1
Drug: Montelukast
Intake of Montelukast

Active Comparator: 2
Drug: Fluticasone
Intake of Fluticasone

Primary Outcome Measures :
  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 Outcome Measures :
  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

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Ages Eligible for Study:   4 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00543686

Goethe University, Department of Pulmonology
Frankfurt, Hessen, Germany, 60590
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Principal Investigator: Stefan Zielen, Prof. Dr. Johann Wolfgang Goethe-University Frankfurt, Zentrum für Kinderheilkunde I, Haus 32, Abt. Pneumologie

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Prof Stefan Zielen, Goethe University, Childrens Hospital, Dpt of Pulmonology, Frankfurt Identifier: NCT00543686     History of Changes
Other Study ID Numbers: 165/07/FFM
First Posted: October 15, 2007    Key Record Dates
Last Update Posted: February 4, 2009
Last Verified: February 2009

Keywords provided by Johann Wolfgang Goethe University Hospital:
Pre-School Asthma
Responder Profiles
Children with Pre-School Asthma

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Leukotriene Antagonists
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action