Asthma, Rhinitis, Other Respiratory DiseasesOmalizumab improves asthma-related quality of life in patients with severe allergic asthma☆,☆☆,★
Section snippets
Study design and patients
These analyses were conducted as part of a multicenter, 28-week, randomized, double-blind, placebo-controlled core study with an additional 24-week double-blind extension phase to assess the efficacy, safety, and tolerability of subcutaneous omalizumab in adolescents and adults with severe allergic asthma. The protocol and main clinical-tolerability findings for the core study are reported in full elsewhere.16 Briefly, patients aged 12 to 75 years who were symptomatic despite moderate-to-high
Results
A total of 525 patients were randomized to study medication in the 28-week core study (omalizumab, n = 268; placebo, n = 257). Nineteen (7.1%) patients receiving omalizumab and 34 (13.2%) placebo recipients withdrew prematurely. Unsatisfactory therapeutic effect (1 vs 14), withdrawal of consent (7 vs 11), administrative problems (4 vs 2), and loss to follow-up (4 vs 4) were the most common reasons for early termination in the omalizu-mab and placebo groups, respectively.
Some 460 patients
Discussion
Asthma is a chronic disease that can result in significant impairment of physical and psychosocial well-being in affected individuals. A thorough QOL assessment, in parallel with routine clinical evaluations, should therefore form an important aspect of determining the treatment response in asthma clinical trials. In the present trial data from a validated asthma-specific QOL instrument demonstrated clearly a significant improvement over the 1-year course of the study for patients receiving
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Cited by (0)
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Supported by a grant from Novartis Pharmaceuticals Corp, East Hanover, NJ, and Genentech, Inc, South San Francisco, Calif.
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*The additional members of the Omalizumab Study Group are listed in the Appendix.
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Reprint requests: Niroo Gupta, MD, PhD, Novartis Pharmaceuticals Corporation, 1 Health Plaza, Bldg 122/N208, East Hanover, NJ 07936-1080.