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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Montelukast
Salmeterol
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Autonomic Agents
Bronchodilator Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Leukotriene Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014