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

NCT00655616 | Completed DMC

• 1 other identifier: sm2006msd01
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• 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

  Every 3 months

Secondary Outcomes (1)

• Oral montelukast is associated with improved asthma specific quality-of-life in comparison to inhaled salmeterol over a period of 1 year

  Every 3 months

Study Arms (2)

1

ACTIVE COMPARATOR

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

2

PLACEBO COMPARATOR

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

Interventions

Montelukast Placebo DRUG

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

2

Salmeterol, Montelukast DRUG

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

1

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Dundee: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Maternal and Child Health Sciences, Ninewells Hospital and Medical School

Dundee, Tayside, DD1 9SY, United Kingdom

Location

Related Publications (2)

• 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. doi: 10.1136/thx.2006.059386. Epub 2006 Jun 13.

  PMID: 16772309 BACKGROUND

• Lipworth BJ, Basu K, Donald HP, Tavendale R, Macgregor DF, Ogston SA, Palmer CN, Mukhopadhyay S. Tailored second-line therapy in asthmatic children with the Arg(16) genotype. Clin Sci (Lond). 2013 Apr;124(8):521-8. doi: 10.1042/CS20120528.

  PMID: 23126384 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Salmeterol Xinafoate; montelukast

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines

Study Officials

• Somnath Mukhopadhyay, FRCPCH,PhD

  University of Dundee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 4, 2008
• First Posted: April 10, 2008
• Study Start: August 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: December 1, 2009
• Last Updated: March 24, 2011

Record last verified: 2009-02

Locations

GB (1)