Leukotriene Receptor Antagonists or Steroids in Pre-School Asthma - Full Text View

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

This study is currently recruiting participants.

Verified by Johann Wolfgang Goethe University Hospitals, August 2007

Sponsored by:	Johann Wolfgang Goethe University Hospitals
Information provided by:	Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:	NCT00543686

Purpose

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	Intervention	Phase
Asthma	Drug: Intake of Montelukast Drug: Intake of Fluticasone	Phase II

MedlinePlus related topics: Allergy Asthma

Drug Information available for: Fluticasone Fluticasone propionate Montelukast sodium Montelukast

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:

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:

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

Estimated Enrollment:	100
Study Start Date:	August 2007

Arms	Assigned Interventions
1: Active Comparator Montelukast	Drug: Intake of Montelukast
2: Active Comparator Fluticasone	Drug: Intake of Fluticasone

Eligibility

Ages Eligible for Study:	4 Years to 6 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00543686

Locations

Germany, Hessen
Goethe University, Department of Pulmonology	Recruiting
Frankfurt, Hessen, Germany, 60590
Contact: Stefan Zielen, M.D., Ph.D. 0049-69-6301 ext 83011 Stefan.Zielen@kgu.de
Contact: Tatjana Müller 0049-69-6301 ext 5381 Tatjana.Mueller@kgu.de
Principal Investigator: Stefan Zielen, M.D., Ph.D.

Sponsors and Collaborators

Johann Wolfgang Goethe University Hospitals

Investigators

Principal Investigator:

Stefan Zielen, Prof. Dr.

Johann Wolfgang Goethe-University Frankfurt, Zentrum für Kinderheilkunde I, Haus 32, Abt. Pneumologie

More Information

Study ID Numbers:	165/07/FFM
Study First Received:	October 11, 2007
Last Updated:	October 12, 2007
ClinicalTrials.gov Identifier:	NCT00543686
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Johann Wolfgang Goethe University Hospitals:

Pre-School Asthma
Responder Profiles
Fluticasone

Montelukast
Leukotriene
Children with Pre-School Asthma

Study placed in the following topic categories:

Montelukast
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Infectious Mononucleosis
Lung Diseases

Hypersensitivity, Immediate
Fluticasone
Asthma
Leukotriene Antagonists
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Bronchial Diseases
Immune System Diseases
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents

Anti-Allergic Agents
Pharmacologic Actions
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Bronchodilator Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on January 15, 2009