Add-on salmeterol versus montelukast in Arg/Arg-16 asthmatics
| ISRCTN | ISRCTN49849003 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN49849003 |
| ClinicalTrials.gov number | NCT00655616 |
| Secondary identifying numbers | sm2006msd01 |
- Submission date
- 18/04/2008
- Registration date
- 31/07/2008
- Last edited
- 09/11/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Somnath Mukhopadhyay
Scientific
Scientific
Maternal and Child Health Sciences
Ninewells Hospital and Medical School
Tayside
Dundee
DD1 9SY
United Kingdom
| Phone | +44 (0)1382 660111 ext. 36297 |
|---|---|
| s.mukhopadhyay@dundee.ac.uk |
Study information
| Study design | Interventional, single-centre, randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details provided in the interventions field to request a patient information sheet |
| Scientific title | A proof-of-concept study to evaluate the benefit from add-on therapy with montelukast versus salmeterol in children with asthma carrying the Arg/Arg-16 beta2-receptor genotype |
| Study objectives | The purpose of this study is to determine whether patients with asthma who carry a genotype associated with adverse outcomes with long-acting beta-2 agonists like salmeterol show greater benefit from the use of an asthma drug that works via alternative pathways like montelukast. |
| Ethics approval(s) | Ethics approval received from Tayside Committee on Medical Research Ethics on the 2nd November 2006 (ref: 06/S1401/86). |
| Health condition(s) or problem(s) studied | Asthma |
| Intervention | Group one (comparison): 1. Seretide 100 Accuhaler (50 micrograms of salmeterol and 100 micrograms of fluticasone propionate) 1 dose twice daily plus 1 tablet daily of placebo montelukast 2. Seretide 250 Accuhaler (50 micrograms of salmeterol and 250 micrograms of fluticasone propionate) 1 dose twice daily plus 1 tablet daily of placebo montelukast 3. Seretide 500 Accuhaler (50 micrograms of salmeterol and 500 micrograms of fluticasone propionate) 1 dose twice daily plus 1 tablet daily of placebo montelukast Group two (active): 1. Flixotide Accuhaler (fluticasone propionate) 50 micrograms per blister; 1 blister dose twice daily plus 1 tablet daily of montelukast 2. Flixotide Accuhaler (fluticasone propionate) 100 micrograms per blister; 1 blister dose twice daily plus 1 tablet daily of montelukast 3. Flixotide Accuhaler (fluticasone propionate) 250 micrograms per blister; 1 blister dose twice daily plus 1 tablet daily of montelukast 4. Flixotide Accuhaler (fluticasone propionate) 500 micrograms per blister; 1 blister dose twice daily plus 1 tablet daily of montelukast Doses of montelukast or placebo: Up to 6 years: 4 mg once daily 6 - 14 years: 5 mg once daily 15 years and above: 10 mg once daily The total duration of treatment and follow-up for all treatment arms is one year. Please use the following contact details to request a patient information sheet: Dr Kaninika Basu Maternal and Child Health Sciences Ninewells Hospital and Medical School University of Dundee Dundee DD1 9SY Email: k.basu@dundee.ac.uk Tel: +44 (0)1382 660111 |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Montelukast, salmeterol, fluticasone propionate |
| Primary outcome measure | Oral montelukast is associated with reduced school absences in comparison to inhaled salmeterol over a period of 1 year in Arg/Arg-16 asthmatic children. |
| Secondary outcome measures | 1. Oral montelukast is associated with reduced out-of hours visits/hospital visits or admissions in comparison to inhaled salmeterol over a period of 1 year 2. Oral montelukast is associated with a reduction in airway resistance in comparison to inhaled salmeterol over a period of 1 year 3. Oral montelukast is associated with reduced exhaled nitric oxide levels in comparison to inhaled salmeterol over a period of 1 year 4. Oral montelukast is associated with reduced salivary eosinophilic cationic protein levels in comparison to inhaled salmeterol over a period of 1 year 5. Oral montelukast is associated with improved asthma specific quality-of-life in comparison to inhaled salmeterol over a period of 1 year 6. Oral montelukast is associated with improved morning peak expiratory flow rate in comparison to inhaled salmeterol over a period of 1 year |
| Overall study start date | 01/08/2007 |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 5 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 120 |
| Key inclusion criteria | All children and adolescents (5 - 18 years, either sex) with asthma in Tayside (Scotland) known: 1. To carry the Arg/Arg-16 genotype, and 2. Currently on inhaled steroids, and 3. Inhaled bronchodilators according to need Will be telephoned or contacted through home visits to establish if they have had: 1. Any school absences from asthma, or 2. Out-of-hours visits to General Practitioner (GP)/hospital visits or admissions due to asthma over the previous 12 months |
| Key exclusion criteria | The presence of serious respiratory or multi-system disease (e.g. cystic fibrosis, cancer under current treatment) |
| Date of first enrolment | 01/08/2007 |
| Date of final enrolment | 31/12/2009 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Maternal and Child Health Sciences
Dundee
DD1 9SY
United Kingdom
DD1 9SY
United Kingdom
Sponsor information
University of Dundee (UK)
University/education
University/education
c/o Mr Simon Temperley
Dundee
DD1 4HU
Scotland
United Kingdom
| Website | http://www.dundee.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/03h2bxq36 |
Funders
Funder type
University/education
University of Dundee (UK)
No information available
Merck Sharp & Dohme Limited (MSD) (UK)
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/04/2013 | Yes | No |
