The efficacy of adding budesonide/formoterol to ipratropium plus theophylline in managing severe chronic obstructive pulmonary disease: an open-label, randomized study in China
| Autor: | Kewu Huang, Yanfei Guo, Jian Kang, Li An, Zeguang Zheng, Lijun Ma, Liping Peng, Hongyang Wang, Rong Su, Yohji Itoh, Chen Wang |
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| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: | |
| Zdroj: | Therapeutic Advances in Respiratory Disease, Vol 13 (2019) |
| Druh dokumentu: | article |
| ISSN: | 1753-4666 17534666 |
| DOI: | 10.1177/1753466619853500 |
| Popis: | Background: Patients diagnosed with chronic obstructive pulmonary disease (COPD) in China are commonly prescribed ipratropium plus theophylline (I+T) therapy. Studies have shown that an inhaled corticosteroid (ICS)/long-acting β 2 -agonist (LABA) combination is also efficacious in reducing symptoms and exacerbations. This study evaluated the efficacy and tolerability of adding budesonide/formoterol (BUD/FORM) to I+T in Chinese patients with severe COPD. Methods: A randomized, parallel-group, open-label, multicenter phase IV study (Clinical Trials.gov identifier: NCT01415518) was conducted in China. Patients received either BUD/FORM (160/4.5 µg; two inhalations twice daily [bid] via Turbuhaler ® ) + I (20 µg per inhalation, two inhalations four times daily) + T (100 mg bid) or I+T alone for 12 weeks. The primary efficacy variable was change from baseline in predose forced expiratory volume in 1 s (FEV 1 ). Results: A total of 584 patients were randomized equally between treatment groups. At the end of the study, the BUD/FORM plus I+T group displayed significant improvements in predose FEV 1 versus the I+T group (between-group difference 6.9%; 95% confidence interval [CI]: 4.3, 9.6; p < 0.0001). Forced vital capacity, inspiratory capacity, peak expiratory flow and health-related quality of life (HRQoL) scores were significantly improved (all p |
| Databáze: | Directory of Open Access Journals |
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