{"doi":"10.17615/md2j-3z93","title":"A randomized, seven-day study to assess the efficacy and safety of a glycopyrrolate/formoterol fumarate fixed-dose combination metered dose inhaler using novel Co-Suspension™ Delivery Technology in patients with moderate-to-very severe chronic obstructive pulmonary disease","abstract":"Abstract Background Long-acting muscarinic antagonist/long-acting β 2 -agonist combinations are recommended for patients whose chronic obstructive pulmonary disease (COPD) is not managed with monotherapy. We assessed the efficacy and safety of glycopyrrolate (GP)/formoterol fumarate (FF) fixed-dose combination delivered via a Co-Suspension™ Delivery Technology-based metered dose inhaler (MDI) (GFF MDI). Methods This was a Phase IIb randomized, multicenter, placebo-controlled, double-blind, chronic-dosing (7 days), crossover study in patients with moderate-to-very severe COPD (NCT01085045). Treatments included GFF MDI twice daily (BID) (GP/FF 72/9.6 μg or 36/9.6 μg), GP MDI 36 μg BID, FF MDI 7.2 and 9.6 μg BID, placebo MDI, and open-label formoterol dry powder inhaler (FF DPI) 12 μg BID or tiotropium DPI 18 μg once daily. The primary endpoint was forced expiratory volume in 1 s area under the curve from 0 to 12 h (FEV 1 AUC 0–12 ) on Day 7 relative to baseline FEV 1 . Secondary endpoints included pharmacokinetics and safety. Results GFF MDI 72/9.6 μg or 36/9.6 μg led to statistically significant improvements in FEV 1 AUC 0–12 after 7 days’ treatment versus monocomponent MDIs, placebo MDI, tiotropium, or FF DPI (p ≤ 0.0002). GFF MDI 36/9.6 μg was non-inferior to GFF MDI 72/9.6 μg and monocomponent MDIs were non-inferior to open-label comparators. Pharmacokinetic results showed glycopyrrolate and formoterol exposure were decreased following administration via fixed-dose combination versus monocomponent MDIs; however, this was not clinically meaningful. GFF MDI was well tolerated. Conclusions GFF MDI 72/9.6 μg and 36/9.6 μg BID improve lung function and are well tolerated in patients with moderate-to-very severe COPD. Trial registration ClinicalTrials.gov NCT01085045. Registered 9 March 2010.","journal":"UNC Libraries","year":2020,"id":143106,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":0,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9515,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2020-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":610144,"name":"James F. Donohue","orcid":"0000-0002-4439-6866","position":1,"is_corresponding":false},{"id":610763,"name":"Sarvajna Dwivedi","orcid":null,"position":2,"is_corresponding":false},{"id":28436,"name":"Klaus F. Rabe","orcid":"0000-0002-7020-1401","position":3,"is_corresponding":false},{"id":610145,"name":"Patrick Darken","orcid":"0000-0002-5608-2717","position":4,"is_corresponding":false},{"id":610764,"name":"Chad Orevillo","orcid":null,"position":5,"is_corresponding":false},{"id":443474,"name":"Leonardo M. Fabbri","orcid":"0000-0001-8894-1689","position":6,"is_corresponding":false},{"id":610146,"name":"Edward Kerwin","orcid":"0000-0002-1697-9036","position":7,"is_corresponding":false},{"id":607479,"name":"Michael A. Golden","orcid":null,"position":8,"is_corresponding":false},{"id":464808,"name":"Charles Fogarty","orcid":null,"position":9,"is_corresponding":false},{"id":610147,"name":"Colin Reisner","orcid":"0000-0003-1856-9863","position":10,"is_corresponding":false},{"id":610765,"name":"St Rose, Earl","orcid":null,"position":11,"is_corresponding":false},{"id":610766,"name":"Selwyn Spangenthal","orcid":null,"position":12,"is_corresponding":false},{"id":237298,"name":"Tracy Fischer","orcid":"0000-0003-4859-3776","position":13,"is_corresponding":false},{"id":33125,"name":"Fernando J. Martínez","orcid":"0000-0002-2412-3182","position":14,"is_corresponding":false},{"id":464057,"name":"Gary T. Ferguson","orcid":"0000-0002-3277-4110","position":15,"is_corresponding":false},{"id":610143,"name":"Shannon Strom","orcid":"0009-0001-2305-0604","position":0,"is_corresponding":true}],"reference_count":0,"raw_metadata":{"citation_network_status":"fetched"},"created_at":"2026-07-18T23:17:34.768426Z","pmid":null,"pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}