Asthma Respiratory Asthma
Conditions
Interventions
Patients are receiving 4 mg of Montelukast as a chewable tablet or Fluticasone propionate 50 mcg 2 puffs metered dose inhaler (MDI) twice a day via babyhaler each with a matching placebo or only plac
Sponsors
Merck Sharp and Dohme BV (Netherlands)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in average symptom scores and symptom free days and nights during daily record periods between the three treatments in the 3 subgroups. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Difference in forced oscillation technique (FOT) parameters (respiratory resistance [Rrs], Rrs6, dRrs/df, reactance [Xrs]) and Rint parameters and salbutamol rescue medication between treatments in the 3 subgroups 2. Difference in additional rescue treatments between treatments 3. Comparison of the adverse events between treatments 4. Comparison of the number of socio-economic consequences of the pulmonary problems 5. Difference in eosinophil values between treatments | — |
Countries
Netherlands
Outcome results
None listed