Trials / Completed
CompletedNCT00543686
Leukotriene Receptor Antagonists or Steroids in Pre-School Asthma
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- Johann Wolfgang Goethe University Hospital · Academic / Other
- Sex
- All
- Age
- 4 Years – 6 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Montelukast | Intake of Montelukast |
| DRUG | Fluticasone | Intake of Fluticasone |
Timeline
- Start date
- 2007-08-01
- Primary completion
- 2009-01-01
- Completion
- 2009-02-01
- First posted
- 2007-10-15
- Last updated
- 2009-02-04
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT00543686. Inclusion in this directory is not an endorsement.