- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00543686
Leukotriene Receptor Antagonists or Steroids in Pre-School Asthma (LOS)
February 3, 2009 updated by: Johann Wolfgang Goethe University Hospital
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
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Hessen
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Frankfurt, Hessen, Germany, 60590
- Goethe University, Department of Pulmonology
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
4 years to 6 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 2
Fluticasone
|
Intake of Fluticasone
|
Active Comparator: 1
Montelukast
|
Intake of Montelukast
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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
Outcome Measure |
---|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Stefan Zielen, Prof. Dr., Johann Wolfgang Goethe-University Frankfurt, Zentrum für Kinderheilkunde I, Haus 32, Abt. Pneumologie
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2007
Primary Completion (Actual)
January 1, 2009
Study Completion (Actual)
February 1, 2009
Study Registration Dates
First Submitted
October 11, 2007
First Submitted That Met QC Criteria
October 12, 2007
First Posted (Estimate)
October 15, 2007
Study Record Updates
Last Update Posted (Estimate)
February 4, 2009
Last Update Submitted That Met QC Criteria
February 3, 2009
Last Verified
February 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Immune System Diseases
- Lung Diseases
- Hypersensitivity, Immediate
- Bronchial Diseases
- Lung Diseases, Obstructive
- Respiratory Hypersensitivity
- Hypersensitivity
- Asthma
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Dermatologic Agents
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Leukotriene Antagonists
- Hormone Antagonists
- Cytochrome P-450 CYP1A2 Inducers
- Cytochrome P-450 Enzyme Inducers
- Anti-Allergic Agents
- Montelukast
- Fluticasone
Other Study ID Numbers
- 165/07/FFM
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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