Add-on Salmeterol Versus Montelukast in Arg/Arg-16 Asthmatics

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by:
University of Dundee
ClinicalTrials.gov Identifier:
NCT00655616
First received: April 4, 2008
Last updated: March 23, 2011
Last verified: February 2009
  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:


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


  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 Sharp & Dohme Corp.
Investigators
Principal Investigator: Somnath Mukhopadhyay, FRCPCH,PhD University of Dundee
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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 April 16, 2014