The Leukotriene Modifier Or Corticosteroid or Corticosteroid-Salmeterol Trial
Summary
This research study will compare the treatment effects of three different asthma medications in asthma subjects whose asthma is well controlled when they take fluticasone, an inhaled corticosteroid. The treatments are fluticasone, montelukast (an anti?leukotriene drug), and a combination therapy of fluticasone and salmeterol (a long-acting beta-agonist). Fluticasone, montelukast, and the combination therapy of fluticasone and salmeterol (Advair Diskus®) are all approved for the treatment of asthma. We are looking at whether the three treatments are equally effective for reducing the number and the severity of asthma attacks in subjects with mild to moderately severe asthma.
Timeline
- Start
- 2003-06
- Primary completion
- 2005-08
- Completion
- 2006-08
Outcome
Missed primary endpoint
paper The hazard ratio for both comparisons was 1.6 (95% confidence interval, 1.1 to 2.6; P=0.03). PMID 17507702 ↗
paper A switch to montelukast results in an increased rate of treatment failure and decreased asthma control; PMID 17507702 ↗
Publications
- Sharma R, Tiwari A, Kho AT, Wang AL, Srivastava U, Piparia S, Desai B, Wong R, Celedon JC, Peters SP, Smith LJ, Irvin CG, Castro M, Weiss ST, Tantisira KG, McGeachie MJ. Circulating microRNAs associated with bronchodilator response in childhood asthma. BMC Pulm Med. 2024 Nov 4;24(1):553. doi: 10.1186/s12890-024-03372-4.
- Sharma R, Tiwari A, Kho AT, Wang AL, Srivastava U, Piparia S, Desai B, Wong R, Celedon JC, Peters SP, Smith LJ, Irvin CG, Castro M, Weiss ST, Tantisira KG, McGeachie MJ. Circulating MicroRNAs associated with Bronchodilator Response in Childhood Asthma. Res Sq [Preprint]. 2023 Jun 29:rs.3.rs-3101724. doi: 10.21203/rs.3.rs-3101724/v1.
- Lang JE, Hossain J, Dixon AE, Shade D, Wise RA, Peters SP, Lima JJ; American Lung Association-Asthma Clinical Research Centers. Does age impact the obese asthma phenotype? Longitudinal asthma control, airway function, and airflow perception among mild persistent asthmatics. Chest. 2011 Dec;140(6):1524-1533. doi: 10.1378/chest.11-0675. Epub 2011 Jul 28.
- Duan QL, Gaume BR, Hawkins GA, Himes BE, Bleecker ER, Klanderman B, Irvin CG, Peters SP, Meyers DA, Hanrahan JP, Lima JJ, Litonjua AA, Tantisira KG, Liggett SB. Regulatory haplotypes in ARG1 are associated with altered bronchodilator response. Am J Respir Crit Care Med. 2011 Feb 15;183(4):449-54. doi: 10.1164/rccm.201005-0758OC. Epub 2010 Sep 17.
- American Lung Association Asthma Clinical Research Centers; Peters SP, Anthonisen N, Castro M, Holbrook JT, Irvin CG, Smith LJ, Wise RA. Randomized comparison of strategies for reducing treatment in mild persistent asthma. N Engl J Med. 2007 May 17;356(20):2027-39. doi: 10.1056/NEJMoa070013.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fluticasone | Other / unclassified | 100 ug | Inhaled |
| Subject | Montelukast | Other / unclassified | 5 mg | — |
| Subject | Montelukast | Other / unclassified | 10 mg | — |
| Subject | Salmeterol | Other / unclassified | 50 ug | — |