The efficacy of adding budesonide/formoterol to ipratropium plus theophylline in managing severe chronic obstructive pulmonary disease: an open-label, randomized study in China
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...
| Main Authors: | , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
SAGE Publishing
2019-06-01
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| Series: | Therapeutic Advances in Respiratory Disease |
| Online Access: | https://doi.org/10.1177/1753466619853500 |
| _version_ | 1828433167663497216 |
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| author | Kewu Huang Yanfei Guo Jian Kang Li An Zeguang Zheng Lijun Ma Liping Peng Hongyang Wang Rong Su Yohji Itoh Chen Wang |
| author_facet | Kewu Huang Yanfei Guo Jian Kang Li An Zeguang Zheng Lijun Ma Liping Peng Hongyang Wang Rong Su Yohji Itoh Chen Wang |
| author_sort | Kewu Huang |
| collection | DOAJ |
| description | 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 < 0.0001) and exacerbation frequency was reduced (43.5% reduction; rate ratio 0.565, 95% CI 0.325, 0.981; p = 0.0425) with BUD/FORM plus I+T versus I+T alone. Conclusion: Patients with severe COPD in China treated with BUD/FORM plus I+T showed significant improvements in lung function and HRQoL and a reduction in exacerbations compared with I+T alone. Both treatments were well tolerated and no safety concerns were noted. The reviews of this paper are available via the supplemental material section . |
| first_indexed | 2024-12-10T18:31:19Z |
| format | Article |
| id | doaj.art-4d759f5c3b9a481e8bed1cafaabcd7f5 |
| institution | Directory Open Access Journal |
| issn | 1753-4666 |
| language | English |
| last_indexed | 2024-12-10T18:31:19Z |
| publishDate | 2019-06-01 |
| publisher | SAGE Publishing |
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| series | Therapeutic Advances in Respiratory Disease |
| spelling | doaj.art-4d759f5c3b9a481e8bed1cafaabcd7f52022-12-22T01:37:56ZengSAGE PublishingTherapeutic Advances in Respiratory Disease1753-46662019-06-011310.1177/1753466619853500The efficacy of adding budesonide/formoterol to ipratropium plus theophylline in managing severe chronic obstructive pulmonary disease: an open-label, randomized study in ChinaKewu HuangYanfei GuoJian KangLi AnZeguang ZhengLijun MaLiping PengHongyang WangRong SuYohji ItohChen WangBackground: 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 < 0.0001) and exacerbation frequency was reduced (43.5% reduction; rate ratio 0.565, 95% CI 0.325, 0.981; p = 0.0425) with BUD/FORM plus I+T versus I+T alone. Conclusion: Patients with severe COPD in China treated with BUD/FORM plus I+T showed significant improvements in lung function and HRQoL and a reduction in exacerbations compared with I+T alone. Both treatments were well tolerated and no safety concerns were noted. The reviews of this paper are available via the supplemental material section .https://doi.org/10.1177/1753466619853500 |
| spellingShingle | Kewu Huang Yanfei Guo Jian Kang Li An Zeguang Zheng Lijun Ma Liping Peng Hongyang Wang Rong Su Yohji Itoh Chen Wang The efficacy of adding budesonide/formoterol to ipratropium plus theophylline in managing severe chronic obstructive pulmonary disease: an open-label, randomized study in China Therapeutic Advances in Respiratory Disease |
| title | The efficacy of adding budesonide/formoterol to ipratropium plus theophylline in managing severe chronic obstructive pulmonary disease: an open-label, randomized study in China |
| title_full | The efficacy of adding budesonide/formoterol to ipratropium plus theophylline in managing severe chronic obstructive pulmonary disease: an open-label, randomized study in China |
| title_fullStr | The efficacy of adding budesonide/formoterol to ipratropium plus theophylline in managing severe chronic obstructive pulmonary disease: an open-label, randomized study in China |
| title_full_unstemmed | The efficacy of adding budesonide/formoterol to ipratropium plus theophylline in managing severe chronic obstructive pulmonary disease: an open-label, randomized study in China |
| title_short | The efficacy of adding budesonide/formoterol to ipratropium plus theophylline in managing severe chronic obstructive pulmonary disease: an open-label, randomized study in China |
| title_sort | efficacy of adding budesonide formoterol to ipratropium plus theophylline in managing severe chronic obstructive pulmonary disease an open label randomized study in china |
| url | https://doi.org/10.1177/1753466619853500 |
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