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:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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: Fluticasone propionate Salmeterol Fluticasone 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 ]

Enrollment:	64
Study Start Date:	August 2007
Study Completion Date:	December 2009
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 The active comparator arm consists of Flixotide® (fluticasone propionate) via accuhaler (Diskus) dry powder inhaler device as per current inhaled steroid dose plus oral montelukast	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
Placebo Comparator: 2 The placebo comparator arm consists of Seretide® (salmeterol plus equivalent dose of fluticasone) via accuhaler dry powder inhaler device as per current inhaled steroid dose plus placebo for montelukast	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

Active Comparator: 1

The active comparator arm consists of Flixotide® (fluticasone propionate) via accuhaler (Diskus) dry powder inhaler device as per current inhaled steroid dose plus oral montelukast

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

Placebo Comparator: 2

The placebo comparator arm consists of Seretide® (salmeterol plus equivalent dose of fluticasone) via accuhaler dry powder inhaler device as per current inhaled steroid dose plus placebo for montelukast

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
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:	Ms Fiona Hogarth, University of Dundee
ClinicalTrials.gov Identifier:	NCT00655616 History of Changes
Other Study ID Numbers:	sm2006msd01
Study First Received:	April 4, 2008
Last Updated:	March 23, 2011
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency; United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Salmeterol
Montelukast
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists

Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on February 09, 2012