drugset / Trial / NCT00655616
Add-on Salmeterol Versus Montelukast in Arg/Arg-16 Asthmatics
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2007-08
- Primary completion
- 2009-08
- Completion
- 2009-12
Publications
- Background 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Montelukast | Other / unclassified | 4 mg | Oral |
| Comparator | Montelukast | Other / unclassified | 5 mg | Oral |
| Comparator | Montelukast | Other / unclassified | 10 mg | Oral |
| Comparator | Salmeterol | Other / unclassified | 50 ug | Inhaled |
| Comparator | Fluticasone propionate | Other / unclassified | 50 ug | Inhaled |
| Comparator | Fluticasone propionate | Other / unclassified | 100 ug | Inhaled |
| Comparator | Fluticasone propionate | Other / unclassified | 250 ug | Inhaled |
| Comparator | Fluticasone propionate | Other / unclassified | 500 ug | Inhaled |