The response to combination therapy treatment regimens in severe/difficult-to-treat asthma

¹ University of Washington, Seattle, Washington
² University of Virginia Health Systems, Charlottesville, Virginia
³ Genentech Inc., South San Francisco, California
⁴ ICON Clinical Research, San Francisco, California
⁵ University of Pittsburgh, Pittsburgh, Pennsylvania
⁶ The TENOR study is sponsored by Genentech, Inc. and Novartis Pharmaceutical Corporation. For a complete list of TENOR Study Group members, please contact Genentech Inc.

^* To whom correspondence should be addressed. E-mail: campbelj{at}u.washington.edu.

	Abstract

Our objective was to assess response to high-dose salmeterol/fluticasone combination (SFC) and low-dose SFC compared to regimens without inhaled corticosteroid (ICS) plus long-acting beta-agonist (LABA) in a large cohort with severe or difficult-to-treat asthma.

Adult cohorts were on low-dose SFC (100/50 or 250/50 µg), high-dose SFC (500/50 µg), and a control group on medications that could include ICS or LABA but not both ICS and LABA. We computed unadjusted and propensity score–adjusted differences in outcomes consistent with components of asthma control, comparing high-dose and low-dose SFC cohorts with controls.

The low-dose SFC cohort had higher asthma-related quality of life (p=0.046) and fewer asthma control problems (p=0.002) compared with controls. The high-dose SFC cohort had higher forced expiratory volume in one second (p=0.046), but higher odds of having severe asthma (p=0.001) compared with controls.

Results support evidence that some asthmatics achieve better outcomes while taking low-dose SFC, but also suggest that those on high-dose SFC fail to achieve significant improvement in many control-related health outcomes as compared with similar patients not taking SFC. These findings suggest limited value of high-dose SFC compared to its alternatives. While additional studies are needed, these findings call for alternative therapeutic approaches in severe/difficult-to-treat asthma.

This article has been cited by other articles:

				M. Humbert Biologics in severe difficult-to-treat asthma: find the right niche! Eur. Respir. Rev., June 1, 2009; 18(112): 51 - 53. [Full Text] [PDF]

				M. Gaga, E. Zervas, and P. Chanez Update on severe asthma: what we know and what we need Eur. Respir. Rev., June 1, 2009; 18(112): 58 - 65. [Full Text] [PDF]