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Your search keyword '"co-suspension delivery technology"' showing total 2 results
Start Over Descriptor "co-suspension delivery technology" Journal journal of aerosol medicine and pulmonary drug delivery
2 results on '"co-suspension delivery technology"'

1. An Open-Label Study Evaluating the Performance of the Dose Indicator in a Metered Dose Inhaler Delivering Glycopyrrolate and Formoterol Fumarate in Patients with Moderate-to-Very Severe Chronic Obstructive Pulmonary Disease

Author

Earl St Rose, Shahid Siddiqui, Gregory Feldman, Peter Mack, Colin Reisner, Krishna Pudi, Faisal Fakih, and Andrea Maes

Subjects
Pulmonary and Respiratory Medicine, Adult, Male, Pharmaceutical Science, Muscarinic Antagonists, 030226 pharmacology & pharmacy, Severe chronic obstructive pulmonary disease, Severity of Illness Index, chronic obstructive pulmonary disease, 03 medical and health sciences, Pulmonary Disease, Chronic Obstructive, 0302 clinical medicine, Open label study, Formoterol Fumarate, Administration, Inhalation, Medicine, Humans, Pharmacology (medical), In patient, GFF MDI, Metered Dose Inhalers, Adrenergic beta-2 Receptor Agonists, Lung, Glycopyrrolate, Original Research, dose indicator, Aged, Aged, 80 and over, business.industry, co-suspension delivery technology, Equipment Design, Middle Aged, Metered-dose inhaler, United States, Bronchodilator Agents, Drug Combinations, Treatment Outcome, 030228 respiratory system, Anesthesia, Female, business
Abstract

Background: GFF MDI is a glycopyrrolate/formoterol fumarate fixed-dose combination metered dose inhaler formulated using co-suspension delivery technology. This open-label, single-arm multicenter study (NCT02268396) evaluated the accuracy, reliability, and functionality of the GFF MDI AeroCount® dose indicator when used by patients with chronic obstructive pulmonary disease (COPD). Patients and Methods: The study enrolled subjects (40–80 years of age) with an established clinical history (≥6 months) of COPD, who completed an electronic diary twice daily to record study-drug administration time, the number of actuations used, and pre- and post-dose dose indicator readings. The primary endpoint was the percentage of devices for which the number of subject-reported actuations was consistent (±20 actuations) with the dose indicator-based actuation count (equal to 130 minus the dose indicator reading) at the end of the treatment period (4 weeks). Safety was monitored throughout the study. Results: A total of 138 subjects with moderate-to-very severe COPD (50.7% male; mean [standard deviation (SD)] age 62.1 [8.3] years) were enrolled and treated. Subject-reported actuation count and dose indicator-based actuation counts were consistent for 96.4% (132/137) of devices at the end of the treatment period (4 weeks) in the intent-to-treat (ITT) population and for all devices in the per-protocol (PP) population. The mean (SD) dose indicator-based actuation and subject-reported actuation counts in the ITT population (n = 137) were 113.4 (18.9) and 117.0 (19.0), respectively, with a mean (SD) difference of 3.6 (7.9). The mean (SD) dose indicator-based actuation and subject-reported actuation counts in the PP population (n = 112) were 116.8 (8.7) and 119.7 (8.1), respectively. There were no unexpected safety findings. Conclusions: This study supported the accuracy, reliability, and utility of the dose indicator integrated into the GFF MDI device when used by patients with COPD.

Published
2019

2. An Open-Label Study Evaluating the Performance of the Dose Indicator in a Metered Dose Inhaler Delivering Glycopyrrolate and Formoterol Fumarate in Patients with Moderate-to-Very Severe Chronic Obstructive Pulmonary Disease.

Author

Pudi K, Feldman G, Fakih F, Mack P, Maes A, Siddiqui S, St Rose E, and Reisner C

Subjects
Administration, Inhalation, Adrenergic beta-2 Receptor Agonists adverse effects, Adult, Aged, Aged, 80 and over, Bronchodilator Agents adverse effects, Drug Combinations, Equipment Design, Female, Formoterol Fumarate adverse effects, Glycopyrrolate adverse effects, Humans, Lung physiopathology, Male, Middle Aged, Muscarinic Antagonists adverse effects, Pulmonary Disease, Chronic Obstructive diagnosis, Pulmonary Disease, Chronic Obstructive physiopathology, Severity of Illness Index, Treatment Outcome, United States, Adrenergic beta-2 Receptor Agonists administration & dosage, Bronchodilator Agents administration & dosage, Formoterol Fumarate administration & dosage, Glycopyrrolate administration & dosage, Lung drug effects, Metered Dose Inhalers, Muscarinic Antagonists administration & dosage, Pulmonary Disease, Chronic Obstructive drug therapy
Abstract

Background: GFF MDI is a glycopyrrolate/formoterol fumarate fixed-dose combination metered dose inhaler formulated using co-suspension delivery technology. This open-label, single-arm multicenter study (NCT02268396) evaluated the accuracy, reliability, and functionality of the GFF MDI AeroCount ® dose indicator when used by patients with chronic obstructive pulmonary disease (COPD)., Patients and Methods: The study enrolled subjects (40-80 years of age) with an established clinical history (≥6 months) of COPD, who completed an electronic diary twice daily to record study-drug administration time, the number of actuations used, and pre- and post-dose dose indicator readings. The primary endpoint was the percentage of devices for which the number of subject-reported actuations was consistent (±20 actuations) with the dose indicator-based actuation count (equal to 130 minus the dose indicator reading) at the end of the treatment period (4 weeks). Safety was monitored throughout the study., Results: A total of 138 subjects with moderate-to-very severe COPD (50.7% male; mean [standard deviation (SD)] age 62.1 [8.3] years) were enrolled and treated. Subject-reported actuation count and dose indicator-based actuation counts were consistent for 96.4% (132/137) of devices at the end of the treatment period (4 weeks) in the intent-to-treat (ITT) population and for all devices in the per-protocol (PP) population. The mean (SD) dose indicator-based actuation and subject-reported actuation counts in the ITT population (n = 137) were 113.4 (18.9) and 117.0 (19.0), respectively, with a mean (SD) difference of 3.6 (7.9). The mean (SD) dose indicator-based actuation and subject-reported actuation counts in the PP population (n = 112) were 116.8 (8.7) and 119.7 (8.1), respectively. There were no unexpected safety findings., Conclusions: This study supported the accuracy, reliability, and utility of the dose indicator integrated into the GFF MDI device when used by patients with COPD.

Published
2019
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