Condition category
Respiratory
Date applied
18/04/2008
Date assigned
31/07/2008
Last edited
09/11/2012
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

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 measures

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

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

http://www.dundee.ac.uk/

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

Results - basic reporting

Publication summary

1. 2012 results in www.ncbi.nlm.nih.gov/pubmed/23126384

Publication citations

  1. 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.

Additional files

Editorial Notes