Condition category
Respiratory
Date applied
08/06/2005
Date assigned
20/07/2005
Last edited
11/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Eric J. Duiverman

ORCID ID

Contact details

Beatrix Children's Hospital
Department of Pediatric Pulmonology
P.O. Box 30001
Groningen
9700 RB
Netherlands
e.j.duiverman@bkk.umcg.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

OBELIKS

Study hypothesis

Montelukast mono-therapy is as effective as Fluticasone mono-therapy in pre-school asthmatic children compared to placebo.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Multi-centre

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Montelukast and Fluticasone propionate

Primary outcome measures

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 trial start date

01/09/2002

Overall trial end date

01/12/2005

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

150

Participant 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

Recruitment start date

01/09/2002

Recruitment end date

01/12/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

Beatrix Children's Hospital
Groningen
9700 RB
Netherlands

Sponsor information

Organisation

Merck Sharp and Dohme BV (Netherlands)

Sponsor details

Postbus 581
Haarlem
2003 PC
Netherlands

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Merck Sharp & Dohme BV (SING-NET-59-01) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes