Evaluation of inhaler technique and achievement and maintenance of mastery of budesonide/formoterol Spiromax® compared with budesonide/formoterol Turbuhaler® in adult patients with asthma: the Easy Low Instruction Over Time (ELIOT) study
Abstract Background Incorrect inhaler technique is a common cause of poor asthma control. This two-phase pragmatic study evaluated inhaler technique mastery and maintenance of mastery with DuoResp® (budesonide-formoterol [BF]) Spiromax® compared with Symbicort® (BF) Turbuhaler® in patients with asth...
| Main Authors: | , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2018-06-01
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| Series: | BMC Pulmonary Medicine |
| Subjects: | |
| Online Access: | http://link.springer.com/article/10.1186/s12890-018-0665-x |
| _version_ | 1819034210192588800 |
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| author | David B. Price Vicky Thomas P. N. Richard Dekhuijzen Sinthia Bosnic-Anticevich Nicolas Roche Federico Lavorini Priyanka Raju Daryl Freeman Carole Nicholls Iain R. Small Erika Sims Guilherme Safioti Janice Canvin Henry Chrystyn |
| author_facet | David B. Price Vicky Thomas P. N. Richard Dekhuijzen Sinthia Bosnic-Anticevich Nicolas Roche Federico Lavorini Priyanka Raju Daryl Freeman Carole Nicholls Iain R. Small Erika Sims Guilherme Safioti Janice Canvin Henry Chrystyn |
| author_sort | David B. Price |
| collection | DOAJ |
| description | Abstract Background Incorrect inhaler technique is a common cause of poor asthma control. This two-phase pragmatic study evaluated inhaler technique mastery and maintenance of mastery with DuoResp® (budesonide-formoterol [BF]) Spiromax® compared with Symbicort® (BF) Turbuhaler® in patients with asthma who were receiving inhaled corticosteroids/long-acting β2-agonists. Methods In the initial cross-sectional phase, patients were randomized to a 6-step training protocol with empty Spiromax and Turbuhaler devices. Patients initially demonstrating ≥1 error with their current device, and then achieving mastery with both Spiromax and Turbuhaler (absence of healthcare professional [HCP]-observed errors), were eligible for the longitudinal phase. In the longitudinal phase, patients were randomized to BF Spiromax or BF Turbuhaler. Co-primary endpoints were the proportions of patients achieving device mastery after three training steps and maintaining device mastery (defined as the absence of HCP-observed errors after 12 weeks of use). Secondary endpoints included device preference, handling error frequency, asthma control, and safety. Exploratory endpoints included assessment of device mastery by an independent external expert reviewing video recordings of a subset of patients. Results Four hundred ninety-three patients participated in the cross-sectional phase, and 395 patients in the longitudinal phase. In the cross-sectional phase, more patients achieved device mastery after three training steps with Spiromax (94%) versus Turbuhaler (87%) (odds ratio [OR] 3.77 [95% confidence interval (CI) 2.05–6.95], p < 0.001). Longitudinal phase data indicated that the odds of maintaining inhaler mastery at 12 weeks were not statistically significantly different (OR 1.26 [95% CI 0.80–1.98], p = 0.316). Asthma control improved in both groups with no significant difference between groups (OR 0.11 [95% CI -0.09–0.30]). An exploratory analysis indicated that the odds of maintaining independent expert-verified device mastery were significantly higher for patients using Spiromax versus Turbuhaler (OR 2.11 [95% CI 1.25–3.54]). Conclusions In the cross-sectional phase, a significantly greater proportion of patients using Spiromax versus Turbuhaler achieved device mastery; in the longitudinal phase, the proportion of patients maintaining device mastery with Spiromax versus Turbuhaler was similar. An exploratory independent expert-verified analysis found Spiromax was associated with higher levels of device mastery after 12 weeks. Asthma control was improved by treatment with both BF Spiromax and BF Turbuhaler. Trial registration EudraCT 2013-004630-14 (registration date 23 January 2014); NCT02570425. |
| first_indexed | 2024-12-21T07:30:06Z |
| format | Article |
| id | doaj.art-1eb7e737e3754e89b0c19246ad5d9519 |
| institution | Directory Open Access Journal |
| issn | 1471-2466 |
| language | English |
| last_indexed | 2024-12-21T07:30:06Z |
| publishDate | 2018-06-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Pulmonary Medicine |
| spelling | doaj.art-1eb7e737e3754e89b0c19246ad5d95192022-12-21T19:11:35ZengBMCBMC Pulmonary Medicine1471-24662018-06-0118111410.1186/s12890-018-0665-xEvaluation of inhaler technique and achievement and maintenance of mastery of budesonide/formoterol Spiromax® compared with budesonide/formoterol Turbuhaler® in adult patients with asthma: the Easy Low Instruction Over Time (ELIOT) studyDavid B. Price0Vicky Thomas1P. N. Richard Dekhuijzen2Sinthia Bosnic-Anticevich3Nicolas Roche4Federico Lavorini5Priyanka Raju6Daryl Freeman7Carole Nicholls8Iain R. Small9Erika Sims10Guilherme Safioti11Janice Canvin12Henry Chrystyn13Observational and Pragmatic Research Institute Pte LtdObservational and Pragmatic Research Institute Pte LtdRadboud University Nijmegen Medical CenterWoolcock Institute, University of Sydney and Sydney Local Health DistrictUniversity Paris DescartesUniversity of FlorenceObservational and Pragmatic Research Institute Pte LtdObservational and Pragmatic Research Institute Pte LtdObservational and Pragmatic Research Institute Pte LtdObservational and Pragmatic Research Institute Pte LtdObservational and Pragmatic Research Institute Pte LtdTeva Pharmaceuticals Europe BVTeva Pharmaceuticals Europe BVObservational and Pragmatic Research Institute Pte LtdAbstract Background Incorrect inhaler technique is a common cause of poor asthma control. This two-phase pragmatic study evaluated inhaler technique mastery and maintenance of mastery with DuoResp® (budesonide-formoterol [BF]) Spiromax® compared with Symbicort® (BF) Turbuhaler® in patients with asthma who were receiving inhaled corticosteroids/long-acting β2-agonists. Methods In the initial cross-sectional phase, patients were randomized to a 6-step training protocol with empty Spiromax and Turbuhaler devices. Patients initially demonstrating ≥1 error with their current device, and then achieving mastery with both Spiromax and Turbuhaler (absence of healthcare professional [HCP]-observed errors), were eligible for the longitudinal phase. In the longitudinal phase, patients were randomized to BF Spiromax or BF Turbuhaler. Co-primary endpoints were the proportions of patients achieving device mastery after three training steps and maintaining device mastery (defined as the absence of HCP-observed errors after 12 weeks of use). Secondary endpoints included device preference, handling error frequency, asthma control, and safety. Exploratory endpoints included assessment of device mastery by an independent external expert reviewing video recordings of a subset of patients. Results Four hundred ninety-three patients participated in the cross-sectional phase, and 395 patients in the longitudinal phase. In the cross-sectional phase, more patients achieved device mastery after three training steps with Spiromax (94%) versus Turbuhaler (87%) (odds ratio [OR] 3.77 [95% confidence interval (CI) 2.05–6.95], p < 0.001). Longitudinal phase data indicated that the odds of maintaining inhaler mastery at 12 weeks were not statistically significantly different (OR 1.26 [95% CI 0.80–1.98], p = 0.316). Asthma control improved in both groups with no significant difference between groups (OR 0.11 [95% CI -0.09–0.30]). An exploratory analysis indicated that the odds of maintaining independent expert-verified device mastery were significantly higher for patients using Spiromax versus Turbuhaler (OR 2.11 [95% CI 1.25–3.54]). Conclusions In the cross-sectional phase, a significantly greater proportion of patients using Spiromax versus Turbuhaler achieved device mastery; in the longitudinal phase, the proportion of patients maintaining device mastery with Spiromax versus Turbuhaler was similar. An exploratory independent expert-verified analysis found Spiromax was associated with higher levels of device mastery after 12 weeks. Asthma control was improved by treatment with both BF Spiromax and BF Turbuhaler. Trial registration EudraCT 2013-004630-14 (registration date 23 January 2014); NCT02570425.http://link.springer.com/article/10.1186/s12890-018-0665-xBudesonide/formoterolDry-powder inhalerInhaler techniqueInhaler masteryIntuitivePragmatic clinical trial |
| spellingShingle | David B. Price Vicky Thomas P. N. Richard Dekhuijzen Sinthia Bosnic-Anticevich Nicolas Roche Federico Lavorini Priyanka Raju Daryl Freeman Carole Nicholls Iain R. Small Erika Sims Guilherme Safioti Janice Canvin Henry Chrystyn Evaluation of inhaler technique and achievement and maintenance of mastery of budesonide/formoterol Spiromax® compared with budesonide/formoterol Turbuhaler® in adult patients with asthma: the Easy Low Instruction Over Time (ELIOT) study BMC Pulmonary Medicine Budesonide/formoterol Dry-powder inhaler Inhaler technique Inhaler mastery Intuitive Pragmatic clinical trial |
| title | Evaluation of inhaler technique and achievement and maintenance of mastery of budesonide/formoterol Spiromax® compared with budesonide/formoterol Turbuhaler® in adult patients with asthma: the Easy Low Instruction Over Time (ELIOT) study |
| title_full | Evaluation of inhaler technique and achievement and maintenance of mastery of budesonide/formoterol Spiromax® compared with budesonide/formoterol Turbuhaler® in adult patients with asthma: the Easy Low Instruction Over Time (ELIOT) study |
| title_fullStr | Evaluation of inhaler technique and achievement and maintenance of mastery of budesonide/formoterol Spiromax® compared with budesonide/formoterol Turbuhaler® in adult patients with asthma: the Easy Low Instruction Over Time (ELIOT) study |
| title_full_unstemmed | Evaluation of inhaler technique and achievement and maintenance of mastery of budesonide/formoterol Spiromax® compared with budesonide/formoterol Turbuhaler® in adult patients with asthma: the Easy Low Instruction Over Time (ELIOT) study |
| title_short | Evaluation of inhaler technique and achievement and maintenance of mastery of budesonide/formoterol Spiromax® compared with budesonide/formoterol Turbuhaler® in adult patients with asthma: the Easy Low Instruction Over Time (ELIOT) study |
| title_sort | evaluation of inhaler technique and achievement and maintenance of mastery of budesonide formoterol spiromax r compared with budesonide formoterol turbuhaler r in adult patients with asthma the easy low instruction over time eliot study |
| topic | Budesonide/formoterol Dry-powder inhaler Inhaler technique Inhaler mastery Intuitive Pragmatic clinical trial |
| url | http://link.springer.com/article/10.1186/s12890-018-0665-x |
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