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
| ISRCTN | ISRCTN38475879 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38475879 |
| Secondary identifying numbers | N/A |
- Submission date
- 08/06/2005
- Registration date
- 20/07/2005
- Last edited
- 11/09/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Eric J. Duiverman
Scientific
Scientific
Beatrix Children's Hospital
Department of Pediatric Pulmonology
P.O. Box 30001
Groningen
9700 RB
Netherlands
| e.j.duiverman@bkk.umcg.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Multi-centre |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | OBELIKS |
| Study objectives | Montelukast mono-therapy is as effective as Fluticasone mono-therapy in pre-school asthmatic children compared to placebo. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Asthma |
| Intervention | 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 placebo for three months. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Montelukast and Fluticasone propionate |
| Primary outcome measure | Difference in average symptom scores and symptom free days and nights during daily record periods between the three treatments in the 3 subgroups. |
| Secondary outcome measures | 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 |
| Overall study start date | 01/09/2002 |
| Completion date | 01/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 2 Years |
| Upper age limit | 5 Years |
| Sex | Both |
| Target number of participants | 150 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2002 |
| Date of final enrolment | 01/12/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Beatrix Children's Hospital
Groningen
9700 RB
Netherlands
9700 RB
Netherlands
Sponsor information
Merck Sharp and Dohme BV (Netherlands)
Industry
Industry
Postbus 581
Haarlem
2003 PC
Netherlands
"ROR" |
https://ror.org/05y28vr04 |
|---|
Funders
Funder type
Industry
Merck Sharp & Dohme BV (SING-NET-59-01) (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
