This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. In patients with mild asthma, an alternative to twice-daily inhaled corticosteroids (ICs) might be available. This investigator-initiated 19-center trial on moderate asthma to try alternative treatments hypothesizes the following: 1) Leukotriene receptor antagonist (LTRA) can be substituted for twice-daily low-dose ICs without loss of control. 2) Half daily dose of ICs plus salmeterol can be substituted for twice-daily ICs. 3) LTRA or combination therapy can be substituted for twice-daily ICs. A similar study was already approved, but salmeterol was the only aim removed when increased mortality was seen in patients treated with salmeterol (a long-acting beta-2 agonist) in the absence of concomitant inhaled steroids. Greater than 450 subjects will be studied. There is a run-in period of over a month followed by randomization into 3 groups: montelukast 10 mg; 1/2 IC (100 mg) + salbuterol (50 mg); IC (100 mg twice daily). Outcome measures will include diaries, peak expiratory flow, symptoms, and quality of life; some centers will include a methacholine challenge. This study was recently initiated on the GCRC. No results are available yet.
Showing the most recent 10 out of 470 publications
