A Standardized Composite Clinical Score for Inhaled Corticosteroids Taper Studies in Asthma

Current asthma treatment guidelines recommend a reduction in inhaled corticosteroid (ICS) doses when appropriate. However, no standardized taper protocols are available to guide ICS tapering in clinical trials or in general practice. This study was designed to determine the safety and effectiveness of tapering the ICS dose in asthmatic patients using specific tapering and rescue protocols. Twenty-two clinically stable asthmatic patients on moderate-to-high doses of ICS were studied. Patients were given either montelukast (10 mg daily) or placebo for 8 weeks and evaluated every 2 weeks. A composite clinical score (0 to 3) comprising lung function, symptoms, and “as-needed” β -agonist use was calculated at each visit. Based on this score, the ICS dose was either tapered, increased, or maintained at each visit. The minimum ICS dose that maintained clinical stability was defined as the last tolerated dose. The results showed that mean percent change from baseline (1523 μg/day, SD = 536) in the last tolerated dose was 49.8% (SD = 37.4). Sixteen patients tolerated at least one taper; of these, 12 tolerated 2 or more tapers. Seven patients tapered completely off ICS. In contrast, six patients did not tolerate a single taper. Ten patients required rescue from mild worsening with an increase in ICS dose, of which nine were successful and one achieved stability with a second ICS dose increase two weeks later. Overall, patients remained clinically stable during tapering. It is concluded that tapering of ICS guided by the clinical composite score was well tolerated. The rescue protocol was effective in restabilizing patients. The results of this study thus support the use of a composite clinical score in larger clinical trials.