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

Sponsor:	University of Dundee
Collaborator:	Merck
Information provided by:	University of Dundee
ClinicalTrials.gov Identifier:	NCT00655616

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

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

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Salmeterol Salmeterol xinafoate Montelukast sodium Montelukast

U.S. FDA Resources

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

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

Locations

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

Sponsors and Collaborators

University of Dundee

Merck

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
Study First Received:	April 4, 2008
Last Updated:	February 23, 2009
ClinicalTrials.gov Identifier:	NCT00655616 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency; United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Bronchial Diseases
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Adrenergic Agonists
Leukotriene Antagonists
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Therapeutic Uses

Salmeterol
Adrenergic beta-Agonists
Immune System Diseases
Asthma
Anti-Asthmatic Agents
Pharmacologic Actions
Montelukast
Autonomic Agents
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on February 08, 2010