Leukotriene Receptor Antagonists or Steroids in Pre-School Asthma
LOS
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
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 asthma
Started Aug 2007
Typical duration for phase_2 asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 11, 2007
CompletedFirst Posted
Study publicly available on registry
October 15, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedFebruary 4, 2009
February 1, 2009
1.4 years
October 11, 2007
February 3, 2009
Conditions
Keywords
Outcome Measures
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
Study Arms (2)
1
ACTIVE COMPARATORMontelukast
2
ACTIVE COMPARATORFluticasone
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Asthma severity ≥ Step 2
- Severe concomitant diseases
- Suspected non-compliance
- age below 4 and age above 7 years
- last study participation \< 30 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Goethe University, Department of Pulmonology
Frankfurt am Main, Hesse, 60590, Germany
Related Publications (1)
Zielen S, Christmann M, Kloska M, Dogan-Yildiz G, Lieb A, Rosewich M, Schubert R, Rose MA, Schulze J. Predicting short term response to anti-inflammatory therapy in young children with asthma. Curr Med Res Opin. 2010 Feb;26(2):483-92. doi: 10.1185/03007990903485148.
PMID: 20001651DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stefan Zielen, Prof. Dr.
Johann Wolfgang Goethe-University Frankfurt, Zentrum für Kinderheilkunde I, Haus 32, Abt. Pneumologie
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 11, 2007
First Posted
October 15, 2007
Study Start
August 1, 2007
Primary Completion
January 1, 2009
Study Completion
February 1, 2009
Last Updated
February 4, 2009
Record last verified: 2009-02