{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,4]],"date-time":"2026-05-04T15:30:50Z","timestamp":1777908650828,"version":"3.51.4"},"reference-count":13,"publisher":"SAGE Publications","issue":"1","license":[{"start":{"date-parts":[[2019,1,29]],"date-time":"2019-01-29T00:00:00Z","timestamp":1548720000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"},{"start":{"date-parts":[[2019,1,29]],"date-time":"2019-01-29T00:00:00Z","timestamp":1548720000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.sagepub.com\/page\/policies\/text-and-data-mining-license"}],"content-domain":{"domain":["journals.sagepub.com"],"crossmark-restriction":true},"short-container-title":["Journal of Aerosol Medicine and Pulmonary Drug Delivery"],"published-print":{"date-parts":[[2019,2,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background:<\/jats:title>\n                    <jats:p>\n                      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\n                      <jats:sup>\u00ae<\/jats:sup>\n                      dose indicator when used by patients with chronic obstructive pulmonary disease (COPD).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Patients and Methods:<\/jats:title>\n                    <jats:p>The study enrolled subjects (40\u201380 years of age) with an established clinical history (\u22656 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 (\u00b120 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results:<\/jats:title>\n                    <jats:p>\n                      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                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      \u2009=\u2009137) 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                      <jats:italic toggle=\"yes\">n<\/jats:italic>\n                      \u2009=\u2009112) were 116.8 (8.7) and 119.7 (8.1), respectively. There were no unexpected safety findings.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions:<\/jats:title>\n                    <jats:p>This study supported the accuracy, reliability, and utility of the dose indicator integrated into the GFF MDI device when used by patients with COPD.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1089\/jamp.2018.1466","type":"journal-article","created":{"date-parts":[[2018,10,18]],"date-time":"2018-10-18T15:16:21Z","timestamp":1539875781000},"page":"40-46","update-policy":"https:\/\/doi.org\/10.1177\/sage-journals-update-policy","source":"Crossref","is-referenced-by-count":3,"title":["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"],"prefix":"10.1177","volume":"32","author":[{"given":"Krishna","family":"Pudi","sequence":"first","affiliation":[{"name":"Upstate Pharmaceutical Research, Greenville, South Carolina."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Gregory","family":"Feldman","sequence":"additional","affiliation":[{"name":"South Carolina Pharmaceutical Research, Spartanburg, South Carolina."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Faisal","family":"Fakih","sequence":"additional","affiliation":[{"name":"Florida Premier Research Institute, LLC, Winter Park, Florida."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Peter","family":"Mack","sequence":"additional","affiliation":[{"name":"Pearl\u2014a member of the AstraZeneca Group, Durham, North Carolina."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrea","family":"Maes","sequence":"additional","affiliation":[{"name":"Pearl\u2014a member of the AstraZeneca Group, Morristown, New Jersey."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Shahid","family":"Siddiqui","sequence":"additional","affiliation":[{"name":"AstraZeneca, Gaithersburg, Maryland."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Earl","family":"St. Rose","sequence":"additional","affiliation":[{"name":"Pearl\u2014a member of the AstraZeneca Group, Morristown, New Jersey."}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Colin","family":"Reisner","sequence":"additional","affiliation":[{"name":"Pearl\u2014a member of the AstraZeneca Group, Morristown, New Jersey."},{"name":"AstraZeneca, Gaithersburg, Maryland."}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"179","published-online":{"date-parts":[[2019,1,29]]},"reference":[{"key":"e_1_3_4_2_2","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(12)61729-2"},{"key":"e_1_3_4_3_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.0030442"},{"key":"e_1_3_4_4_2","unstructured":"Global Initiative for Chronic Obstructive Lung Disease: Global Strategy for the Diagnosis Management and Prevention of COPD. 2018. Available at http:\/\/goldcopd.org Accessed February5 2018."},{"key":"e_1_3_4_5_2","unstructured":"AstraZeneca Pharmaceuticals LP: Bevespi Aerosphere\u2122 Prescribing Information. 2017. Available at http:\/\/azpicentral.com\/bevespi\/bevespi_pi.pdf Accessed February5 2018."},{"key":"e_1_3_4_6_2","unstructured":"U.S. Department of Health and Human Services Food and Drug Administration and Center for Drug Evaluation and Research (CDER): Guidance for Industry: Integration of Dose-Counting Mechanisms into MDI Drug Products. 2003. Available at https:\/\/fda.gov\/downloads\/Drugs\/GuidanceComplianceRegulatoryInformation\/Guidances\/UCM071731.pdf Accessed February8 2018."},{"key":"e_1_3_4_7_2","doi-asserted-by":"publisher","DOI":"10.1183\/09031936.04.00014304"},{"key":"e_1_3_4_8_2","doi-asserted-by":"publisher","DOI":"10.1164\/ajrccm.159.1.9712108"},{"key":"e_1_3_4_9_2","unstructured":"CDC National Center for Health Statistics. Third National Health and Nutrition Examination Survey III Spirometry Procedure Manual. 1988. https:\/\/wwwn.cdc.gov\/nchs\/nhanes\/nhanes3\/manualsandreports.aspx Accessed June21 2018"},{"key":"e_1_3_4_10_2","first-page":"A","article-title":"Evaluation of count accuracy of a top-mounted dose indicator for a pressurized metered-dose inhaler (pMDI): A study involving adult participants na\u00efve to the product","volume":"28","author":"Scarrott P","year":"2015","unstructured":"Scarrott P, , Suggett J, , Sieffert M, , Armstrong K, , and Mitchell J: Evaluation of count accuracy of a top-mounted dose indicator for a pressurized metered-dose inhaler (pMDI): A study involving adult participants na\u00efve to the product. J Aerosol Med Pulm Drug Deliv. 2015; 28:A-7.","journal-title":"J Aerosol Med Pulm Drug Deliv"},{"key":"e_1_3_4_11_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.rmed.2017.03.015"},{"key":"e_1_3_4_12_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.chest.2016.11.028"},{"key":"e_1_3_4_13_2","doi-asserted-by":"publisher","DOI":"10.1186\/s12931-017-0636-4"},{"key":"e_1_3_4_14_2","doi-asserted-by":"publisher","DOI":"10.7326\/M15-0288"}],"container-title":["Journal of Aerosol Medicine and Pulmonary Drug Delivery"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.sagepub.com\/doi\/full-xml\/10.1089\/jamp.2018.1466","content-type":"application\/xml","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1089\/jamp.2018.1466","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.sagepub.com\/doi\/pdf\/10.1089\/jamp.2018.1466","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,5,1]],"date-time":"2026-05-01T14:10:24Z","timestamp":1777644624000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.sagepub.com\/doi\/10.1089\/jamp.2018.1466"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,1,29]]},"references-count":13,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2019,2,1]]}},"alternative-id":["10.1089\/jamp.2018.1466"],"URL":"https:\/\/doi.org\/10.1089\/jamp.2018.1466","relation":{},"ISSN":["1941-2711","1941-2703"],"issn-type":[{"value":"1941-2711","type":"print"},{"value":"1941-2703","type":"electronic"}],"subject":[],"published":{"date-parts":[[2019,1,29]]}}}