Contact information
Type
Scientific
Primary contact
Dr Somnath Mukhopadhyay
ORCID ID
Contact details
Maternal and Child Health Sciences
Ninewells Hospital and Medical School
Tayside
Dundee
DD1 9SY
United Kingdom
+44 (0)1382 660111 ext. 36297
s.mukhopadhyay@dundee.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00655616
Protocol/serial number
sm2006msd01
Study information
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
Acronym
Study hypothesis
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
Ethics approval received from Tayside Committee on Medical Research Ethics on the 2nd November 2006 (ref: 06/S1401/86).
Study design
Interventional, single-centre, randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details provided in the interventions field to request a patient information sheet
Condition
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 names
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 trial start date
01/08/2007
Overall trial end date
31/12/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
120
Participant exclusion criteria
The presence of serious respiratory or multi-system disease (e.g. cystic fibrosis, cancer under current treatment)
Recruitment start date
01/08/2007
Recruitment end date
31/12/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Maternal and Child Health Sciences
Dundee
DD1 9SY
United Kingdom
Sponsor information
Organisation
University of Dundee (UK)
Sponsor details
c/o Mr Simon Temperley
Dundee
DD1 4HU
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
University of Dundee (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Merck Sharp & Dohme Limited (MSD) (UK)
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
Basic results (scientific)
Publication list
1. 2012 results in www.ncbi.nlm.nih.gov/pubmed/23126384
Publication citations
-
Results
Lipworth BJ, Basu K, Donald HP, Tavendale R, Macgregor DF, Ogston SA, Palmer CN, Mukhopadhyay S, Tailored second-line therapy in asthmatic children with the Arg(16) genotype., Clin. Sci., 2013, 124, 8, 521-528, doi: 10.1042/CS20120528.