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Bronchodilator efficacy of 18 μg once-daily tiotropium inhalation via Discair® versus HandiHaler® in adults with chronic obstructive pulmonary disease: randomized, active-controlled, parallel-group, open-label, Phase IV trial.
Int J Chron Obstruct Pulmon Dis. 2016; 11:2859-2867.IJ

Abstract

PURPOSE

To compare the bronchodilator efficacy of 18 μg once-daily tiotropium inhalation administered via Discair® versus HandiHaler® in adults with moderate-to-severe chronic obstructive pulmonary disease (COPD).

PATIENTS AND METHODS

Fifty-eight patients with moderate-to-severe COPD were enrolled in this randomized, active-controlled, parallel-group, open-label, Phase IV non-inferiority trial. Patients were randomly assigned to a test group (n=29, inhalation with Discair) or a reference group (n=29, inhalation with HandiHaler). The primary efficacy parameter was the average maximum change in forced expiratory volume in 1 second (FEV1, in L). Change in forced vital capacity (FVC, in L), %FEV1 and %FVC, the standardized area under the response-time curve (AUC) for the absolute change in FEV1 and FVC, time to onset and peak of response, and safety data were also evaluated.

RESULTS

The test inhaler was non-inferior to the reference inhaler in terms of maximum change in FEV1 at 24 h (unadjusted change: 0.0017 L [95% confidence interval [CI]: -0.0777, 0.0812]; change adjusted for time to reach maximum change in FEV1 and smoking in pack-years: 0.0116 L [95% CI: -0.0699, 0.0931]), based on a non-inferiority margin of 0.100 L. There were also no significant differences between the two groups in maximum change in FVC value from baseline (0.3417 L vs 0.4438 L, P=0.113), percent change from baseline (22.235 vs 20.783 for FEV1, P=0.662; 16.719 vs 20.337 for FVC, P=0.257), and AUC0-24 h (2.949 vs 2.833 L for FEV1, P=0.891; 2.897 vs 4.729 L for FVC, P=0.178). There were no adverse events, serious adverse events, or deaths.

CONCLUSION

Our findings show that the Discair was non-inferior to the HandiHaler. More specifically, these devices had similar clinical efficacy in terms of time-dependent response over 24 h for patients with moderate-to-severe COPD.

Authors+Show Affiliations

Clinics of Chest Diseases, Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital, Istanbul, Turkey.Clinics of Chest Diseases, Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital, Istanbul, Turkey.Clinics of Chest Diseases, Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital, Istanbul, Turkey.Clinics of Chest Diseases, Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital, Istanbul, Turkey.

Pub Type(s)

Clinical Trial, Phase IV
Comparative Study
Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

27920513

Citation

Yildiz, Pinar, et al. "Bronchodilator Efficacy of 18 Μg Once-daily Tiotropium Inhalation Via Discair® Versus HandiHaler® in Adults With Chronic Obstructive Pulmonary Disease: Randomized, Active-controlled, Parallel-group, Open-label, Phase IV Trial." International Journal of Chronic Obstructive Pulmonary Disease, vol. 11, 2016, pp. 2859-2867.
Yildiz P, Bayraktaroglu M, Gorgun D, et al. Bronchodilator efficacy of 18 μg once-daily tiotropium inhalation via Discair® versus HandiHaler® in adults with chronic obstructive pulmonary disease: randomized, active-controlled, parallel-group, open-label, Phase IV trial. Int J Chron Obstruct Pulmon Dis. 2016;11:2859-2867.
Yildiz, P., Bayraktaroglu, M., Gorgun, D., & Secik, F. (2016). Bronchodilator efficacy of 18 μg once-daily tiotropium inhalation via Discair® versus HandiHaler® in adults with chronic obstructive pulmonary disease: randomized, active-controlled, parallel-group, open-label, Phase IV trial. International Journal of Chronic Obstructive Pulmonary Disease, 11, 2859-2867.
Yildiz P, et al. Bronchodilator Efficacy of 18 Μg Once-daily Tiotropium Inhalation Via Discair® Versus HandiHaler® in Adults With Chronic Obstructive Pulmonary Disease: Randomized, Active-controlled, Parallel-group, Open-label, Phase IV Trial. Int J Chron Obstruct Pulmon Dis. 2016;11:2859-2867. PubMed PMID: 27920513.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Bronchodilator efficacy of 18 μg once-daily tiotropium inhalation via Discair® versus HandiHaler® in adults with chronic obstructive pulmonary disease: randomized, active-controlled, parallel-group, open-label, Phase IV trial. AU - Yildiz,Pinar, AU - Bayraktaroglu,Mesut, AU - Gorgun,Didem, AU - Secik,Funda, Y1 - 2016/11/22/ PY - 2016/12/7/entrez PY - 2016/12/7/pubmed PY - 2017/8/9/medline KW - Discair® KW - HandiHaler® KW - bronchodilator efficacy KW - non-inferiority KW - spirometry KW - tiotropium SP - 2859 EP - 2867 JF - International journal of chronic obstructive pulmonary disease JO - Int J Chron Obstruct Pulmon Dis VL - 11 N2 - PURPOSE: To compare the bronchodilator efficacy of 18 μg once-daily tiotropium inhalation administered via Discair® versus HandiHaler® in adults with moderate-to-severe chronic obstructive pulmonary disease (COPD). PATIENTS AND METHODS: Fifty-eight patients with moderate-to-severe COPD were enrolled in this randomized, active-controlled, parallel-group, open-label, Phase IV non-inferiority trial. Patients were randomly assigned to a test group (n=29, inhalation with Discair) or a reference group (n=29, inhalation with HandiHaler). The primary efficacy parameter was the average maximum change in forced expiratory volume in 1 second (FEV1, in L). Change in forced vital capacity (FVC, in L), %FEV1 and %FVC, the standardized area under the response-time curve (AUC) for the absolute change in FEV1 and FVC, time to onset and peak of response, and safety data were also evaluated. RESULTS: The test inhaler was non-inferior to the reference inhaler in terms of maximum change in FEV1 at 24 h (unadjusted change: 0.0017 L [95% confidence interval [CI]: -0.0777, 0.0812]; change adjusted for time to reach maximum change in FEV1 and smoking in pack-years: 0.0116 L [95% CI: -0.0699, 0.0931]), based on a non-inferiority margin of 0.100 L. There were also no significant differences between the two groups in maximum change in FVC value from baseline (0.3417 L vs 0.4438 L, P=0.113), percent change from baseline (22.235 vs 20.783 for FEV1, P=0.662; 16.719 vs 20.337 for FVC, P=0.257), and AUC0-24 h (2.949 vs 2.833 L for FEV1, P=0.891; 2.897 vs 4.729 L for FVC, P=0.178). There were no adverse events, serious adverse events, or deaths. CONCLUSION: Our findings show that the Discair was non-inferior to the HandiHaler. More specifically, these devices had similar clinical efficacy in terms of time-dependent response over 24 h for patients with moderate-to-severe COPD. SN - 1178-2005 UR - https://www.unboundmedicine.com/medline/citation/27920513/Bronchodilator_efficacy_of_18_μg_once_daily_tiotropium_inhalation_via_Discair®_versus_HandiHaler®_in_adults_with_chronic_obstructive_pulmonary_disease:_randomized_active_controlled_parallel_group_open_label_Phase_IV_trial_ L2 - https://dx.doi.org/10.2147/COPD.S119114 DB - PRIME DP - Unbound Medicine ER -