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Bronchodilator Efficacy of a Single-Dose 12/400-µg Formoterol/Budesonide Combination as a Dry Powder for Inhalation Delivered by Discair® in Adult Patients with Moderate-to-Severe Stable COPD: Open-Label, Single-Arm, Phase IV Trial.
Clin Drug Investig. 2019 Oct; 39(10):991-1001.CD

Abstract

BACKGROUND AND OBJECTIVES

A patient-friendly and easy-to-use multi-dose dry powder inhaler, Discair®, has been recently developed. The objective of this study was to evaluate the bronchodilator efficacy of a single-dose 12/400-µg formoterol plus budesonide combination as a dry powder for inhalation delivered by Discair® in adult patients with moderate-to-severe, stable, chronic obstructive pulmonary disease.

METHODS

A total of 33 male patients with moderate-to-severe, chronic obstructive pulmonary disease were included in this single-arm, open-label, phase IV trial. The primary efficacy parameters were the average maximum change in forced expiratory volume in 1 s (FEV1, in L) and time to maximum FEV1 response. Absolute and percent change from baseline in FEV1 and forced vital capacity, maximum change and time to peak forced vital capacity response were also evaluated.

RESULTS

The mean post-bronchodilator FEV1 maximum value was significantly higher than the pre-bronchodilator baseline FEV1 value [1.66 (standard deviation 0.43) vs. 1.32 (standard deviation 0.35), p < 0.001], with an absolute change of 0.34 (standard deviation 0.18) and a percent change of 26.0 (standard deviation 0.14) from baseline to maximum response. The average time to peak FEV1 response was 3.94 h (standard deviation 2.75), while the standardized area under the response-time curve from 0 to 12 h for FEV1 was 2.72 (standard deviation 1.84). The FEV1 and forced vital capacity values recorded at each time point during the 12-h post-bronchodilator period were also significantly higher than the baseline values (p < 0.001 for each).

CONCLUSIONS

Our findings revealed significant changes from baseline in post-bronchodilator peak and average FEV1 and forced vital capacity responses, indicating bronchodilator efficacy of a single-dose 12/400 µg formoterol plus budesonide dry powder formulation delivered by Discair® in patients with chronic obstructive pulmonary disease.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier NCT03028701.

Authors+Show Affiliations

University of Health Sciences, Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital, Istanbul, Turkey. pinary70@yahoo.com.University of Health Sciences, Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital, Istanbul, Turkey.University of Health Sciences, Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital, Istanbul, Turkey.Center for Drug Research and Development and Pharmacokinetic Applications (ARGEFAR), Ege University, Izmir, Turkey.

Pub Type(s)

Clinical Trial, Phase IV
Journal Article

Language

eng

PubMed ID

31332649

Citation

Yildiz, Pinar, et al. "Bronchodilator Efficacy of a Single-Dose 12/400-µg Formoterol/Budesonide Combination as a Dry Powder for Inhalation Delivered By Discair® in Adult Patients With Moderate-to-Severe Stable COPD: Open-Label, Single-Arm, Phase IV Trial." Clinical Drug Investigation, vol. 39, no. 10, 2019, pp. 991-1001.
Yildiz P, Bayraktaroglu M, Gorgun D, et al. Bronchodilator Efficacy of a Single-Dose 12/400-µg Formoterol/Budesonide Combination as a Dry Powder for Inhalation Delivered by Discair® in Adult Patients with Moderate-to-Severe Stable COPD: Open-Label, Single-Arm, Phase IV Trial. Clin Drug Investig. 2019;39(10):991-1001.
Yildiz, P., Bayraktaroglu, M., Gorgun, D., & Yuksel, K. (2019). Bronchodilator Efficacy of a Single-Dose 12/400-µg Formoterol/Budesonide Combination as a Dry Powder for Inhalation Delivered by Discair® in Adult Patients with Moderate-to-Severe Stable COPD: Open-Label, Single-Arm, Phase IV Trial. Clinical Drug Investigation, 39(10), 991-1001. https://doi.org/10.1007/s40261-019-00828-y
Yildiz P, et al. Bronchodilator Efficacy of a Single-Dose 12/400-µg Formoterol/Budesonide Combination as a Dry Powder for Inhalation Delivered By Discair® in Adult Patients With Moderate-to-Severe Stable COPD: Open-Label, Single-Arm, Phase IV Trial. Clin Drug Investig. 2019;39(10):991-1001. PubMed PMID: 31332649.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Bronchodilator Efficacy of a Single-Dose 12/400-µg Formoterol/Budesonide Combination as a Dry Powder for Inhalation Delivered by Discair® in Adult Patients with Moderate-to-Severe Stable COPD: Open-Label, Single-Arm, Phase IV Trial. AU - Yildiz,Pinar, AU - Bayraktaroglu,Mesut, AU - Gorgun,Didem, AU - Yuksel,Kivanc, PY - 2019/7/25/pubmed PY - 2019/12/24/medline PY - 2019/7/24/entrez SP - 991 EP - 1001 JF - Clinical drug investigation JO - Clin Drug Investig VL - 39 IS - 10 N2 - BACKGROUND AND OBJECTIVES: A patient-friendly and easy-to-use multi-dose dry powder inhaler, Discair®, has been recently developed. The objective of this study was to evaluate the bronchodilator efficacy of a single-dose 12/400-µg formoterol plus budesonide combination as a dry powder for inhalation delivered by Discair® in adult patients with moderate-to-severe, stable, chronic obstructive pulmonary disease. METHODS: A total of 33 male patients with moderate-to-severe, chronic obstructive pulmonary disease were included in this single-arm, open-label, phase IV trial. The primary efficacy parameters were the average maximum change in forced expiratory volume in 1 s (FEV1, in L) and time to maximum FEV1 response. Absolute and percent change from baseline in FEV1 and forced vital capacity, maximum change and time to peak forced vital capacity response were also evaluated. RESULTS: The mean post-bronchodilator FEV1 maximum value was significantly higher than the pre-bronchodilator baseline FEV1 value [1.66 (standard deviation 0.43) vs. 1.32 (standard deviation 0.35), p < 0.001], with an absolute change of 0.34 (standard deviation 0.18) and a percent change of 26.0 (standard deviation 0.14) from baseline to maximum response. The average time to peak FEV1 response was 3.94 h (standard deviation 2.75), while the standardized area under the response-time curve from 0 to 12 h for FEV1 was 2.72 (standard deviation 1.84). The FEV1 and forced vital capacity values recorded at each time point during the 12-h post-bronchodilator period were also significantly higher than the baseline values (p < 0.001 for each). CONCLUSIONS: Our findings revealed significant changes from baseline in post-bronchodilator peak and average FEV1 and forced vital capacity responses, indicating bronchodilator efficacy of a single-dose 12/400 µg formoterol plus budesonide dry powder formulation delivered by Discair® in patients with chronic obstructive pulmonary disease. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT03028701. SN - 1179-1918 UR - https://www.unboundmedicine.com/medline/citation/31332649/Bronchodilator_Efficacy_of_a_Single_Dose_12/400_µg_Formoterol/Budesonide_Combination_as_a_Dry_Powder_for_Inhalation_Delivered_by_Discair®_in_Adult_Patients_with_Moderate_to_Severe_Stable_COPD:_Open_Label_Single_Arm_Phase_IV_Trial_ L2 - https://dx.doi.org/10.1007/s40261-019-00828-y DB - PRIME DP - Unbound Medicine ER -