Add-on salmeterol versus montelukast in Arg/Arg-16 asthmatics

ISRCTN	ISRCTN49849003
DOI	https://doi.org/10.1186/ISRCTN49849003
ClinicalTrials.gov (NCT)	NCT00655616
Protocol serial number	sm2006msd01
Sponsor	University of Dundee (UK)
Funders	University of Dundee (UK), Merck Sharp & Dohme Limited (MSD) (UK)

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

Maternal and Child Health Sciences
Ninewells Hospital and Medical School
Tayside
Dundee
DD1 9SY
United Kingdom

Phone	+44 (0)1382 660111 ext. 36297
Email	s.mukhopadhyay@dundee.ac.uk

Study information

Primary study design	Interventional
Study design	Interventional, single-centre, randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Montelukast, salmeterol, fluticasone propionate
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	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
Completion date	31/12/2009

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	5 Years
Upper age limit	18 Years
Sex	All
Target sample size at registration	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

United Kingdom
Scotland

Study participating centre

Maternal and Child Health Sciences

Dundee
DD1 9SY
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes