Add-on Salmeterol Versus Montelukast in Arg/Arg-16 Asthmatics - Full Text View

Purpose

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.

Condition	Intervention
Asthma	Drug: Montelukast Placebo Drug: Salmeterol, Montelukast

MedlinePlus related topics:

Asthma

ChemIDplus related topics:

Fluticasone propionate Fluticasone Montelukast sodium Montelukast Salmeterol Salmeterol xinafoate Isoetharine Isoetharine hydrochloride Isoetharine mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Parallel Assignment, Safety Study

Official 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

Further study details as provided by University of Dundee:

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 [ Time Frame: Every 3 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Oral montelukast is associated with improved asthma specific quality-of-life in comparison to inhaled salmeterol over a period of 1 year [ Time Frame: Every 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	120
Study Start Date:	August 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: Salmeterol, Montelukast Flixotide Accuhaler 50 micrograms per blister, 1 blister dose twice daily plus 1 tablet daily of montelukast Flixotide Accuhaler 100 micrograms per blister; 1 blister dose twice daily plus 1 tablet daily of montelukast Flixotide Accuhaler 250 micrograms per blister; 1 blister dose twice daily plus 1 tablet daily of montelukast Flixotide Accuhaler 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
2: Placebo Comparator	Drug: Montelukast Placebo Seretide 100 Accuhaler 1 dose twice daily plus 1 tablet daily of placebo montelukast Seretide 250 Accuhaler 1 dose twice daily plus 1 tablet daily of placebo montelukast Seretide 500 Accuhaler 1 dose twice daily plus 1 tablet daily of placebo 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

Show Detailed Description

Eligibility

Ages Eligible for Study:	5 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

All children and adolescents (5-18 years) with asthma in Tayside (Scotland) known:

To carry the Arg/Arg-16 genotype and
Currently on inhaled steroids and
Inhaled bronchodilators according to need will be telephoned or contacted through home visits to establish if they have had:
- Any school absences from asthma or
- Out-of-hours visits to GP/hospital visits or admissions due to asthma over the previous 12 months.

Exclusion Criteria:

The presence of serious respiratory or multi-system disease (e.g. cystic fibrosis, cancer under current treatment)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00655616

Contacts


Contact: Somnath Mukhopadhyay, FRCPCH,PhD	44-013-8266-0111 ext 36297	s.mukhopadhyay@dundee.ac.uk

Contact: Kaninika Basu, MBBS	44-013-8266-0111 ext 36297	k.basu@dundee.ac.uk

Locations


United Kingdom, Tayside
	Maternal and Child Health Sciences, Ninewells Hospital and Medical School	Recruiting
	Dundee, Tayside, United Kingdom, DD1 9SY
	Contact: Kaninika Basu, MBBS 44-013-8266-0111 ext 36297 k.basu@dundee.ac.uk

Sponsors and Collaborators

University of Dundee

Merck Sharp & Dohme

Investigators


Principal Investigator:	Somnath Mukhopadhyay, FRCPCH,PhD	University of Dundee

More Information

Publications:

Palmer CN, Lipworth BJ, Lee S, Ismail T, Macgregor DF, Mukhopadhyay S. Arginine-16 beta2 adrenoceptor genotype predisposes to exacerbations in young asthmatics taking regular salmeterol. Thorax. 2006 Nov;61(11):940-4. Epub 2006 Jun 13.

Responsible Party:	University of Dundee ( Mr Simon Temperley )
Study ID Numbers:	sm2006msd01
First Received:	April 4, 2008
Last Updated:	April 18, 2008
ClinicalTrials.gov Identifier:	NCT00655616
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency; United Kingdom: Research Ethics Committee

Study placed in the following topic categories:

Montelukast

Hypersensitivity

Lung Diseases, Obstructive

Salmeterol

Respiratory Tract Diseases

Lung Diseases

Hypersensitivity, Immediate

Fluticasone

Asthma

Leukotriene Antagonists

Respiratory Hypersensitivity

Additional relevant MeSH terms:

Respiratory System Agents

Neurotransmitter Agents

Bronchial Diseases

Immune System Diseases

Adrenergic beta-Agonists

Adrenergic Agents

Molecular Mechanisms of Pharmacological Action

Hormone Antagonists

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Anti-Asthmatic Agents

Adrenergic Agonists

Pharmacologic Actions

Autonomic Agents

Therapeutic Uses

Peripheral Nervous System Agents

Bronchodilator Agents

ClinicalTrials.gov processed this record on October 10, 2008

Sponsors and Collaborators:	University of Dundee Merck Sharp & Dohme
Information provided by:	University of Dundee
ClinicalTrials.gov Identifier:	NCT00655616