ISRCTN38475879CompletedNot Applicable
Multicentre, parallel group, randomised, double blind study to investigate the efficacy of Montelukast (MK) + Fluticasone (FP) placebo versus Fluticasone + MK-placebo versus MK-placebo + FP-placebo in preschool children with asthma or asthma-like symptoms during a 3 months study period
Merck Sharp and Dohme BV (Netherlands)0 sites150 target enrollmentStarted: July 20, 2005Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 150
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Children aged 2 to and including 5 years with asthma or asthma-like symptoms of sufficient severity to justify the use of prophylactic treatment
- •2. A signed and dated written informed consent is obtained from both parents or the subject's legally acceptable representatives prior to study participation
- •3. Patients and their parents should be able to perform the study according to the protocol and use the study and rescue medication
- •4. Parents should agree and be capable to fill out daily record cards and the questionnaires
Exclusion Criteria
- •1. Patients who are currently using systemic or inhaled corticosteroids or leucotriene antagonists
- •2. Patients who have used in the 2 months prior to visit 1 oral corticosteroids or in the 4 weeks prior to visit 1 inhaled corticosteroids or leucotriene antagonists
- •3. Patients who have been hospitalized for their asthmatic symptoms in the two weeks prior to visit 1
- •4. Patients who have known respiratory disorders other than asthma (e.g. broncho-pulmonary dysplasia, cystic fibrosis, tuberculosis etc.)
- •5. Patients who have known clinical and laboratory evidence of serious uncontrolled systemic disease
- •6. Patients with known anatomical abnormalities of the airways
- •7. Patients who are suspected to be hypersensitive to one of the drugs involved in this study
- •8. Patients who use systemic medication that interferes with pulmonary control
- •9. Patients previously randomized in this study
- •10. Patients who are currently participating in another clinical trial
- •11. When the physician considers it to be the patient detriment to participate in the study
- •12. Exacerbation of asthma or asthma-like symptoms that has to be treated with inhaled or systemic corticosteroids during the run-in period
Investigators
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