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 个研究点目标入组 150 人开始时间: 2005年7月20日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•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

•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

发起方

Merck Sharp and Dohme BV (Netherlands)