Efficacy and safety of aclidinium/formoterol versus monotherapies and aclidinium versus placebo in Chinese and other Asian patients with moderate-to-severe COPD: The AVANT Phase 3 study
AVANT was a Phase 3, 24-week, randomized, parallel-group, double-blind, double-dummy, placebo-controlled study to assess the efficacy and safety of aclidinium/formoterol 400 μg/12 μg combination vs monotherapies and aclidinium vs placebo (1:1:1:1) in Asian patients (∼70% of whom were Chinese) with m...
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| Veröffentlicht in: | Respiratory medicine 2023-11, Vol.218, p.107393-107393, Article 107393 |
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| creator | Sun, Yongchang Molins, Eduard Daoud, Sami Z. Trivedi, Roopa Stewart, Catherine Lamarca, Rosa Bharali, Pranob Garcia-Gil, Esther |
| description | AVANT was a Phase 3, 24-week, randomized, parallel-group, double-blind, double-dummy, placebo-controlled study to assess the efficacy and safety of aclidinium/formoterol 400 μg/12 μg combination vs monotherapies and aclidinium vs placebo (1:1:1:1) in Asian patients (∼70% of whom were Chinese) with moderate-to-severe stable chronic obstructive pulmonary disease. Endpoints were analyzed hierarchically to incorporate type I error control. At Week 24, aclidinium/formoterol demonstrated improvements from baseline in 1-h morning post-dose forced expiratory volume in 1 s (FEV1) vs aclidinium (least squares [LS] mean 92 mL; 95% confidence interval [CI] 60, 124 mL; p |
| doi_str_mv | 10.1016/j.rmed.2023.107393 |
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•Aclidinium/formoterol and aclidinium knowledge is extended to Asian COPD patients.•Improvements in bronchodilation and QoL were clinically meaningful vs controls.•Treatment was well tolerated; safety findings were consistent with known profiles.</description><identifier>ISSN: 0954-6111</identifier><identifier>EISSN: 1532-3064</identifier><identifier>DOI: 10.1016/j.rmed.2023.107393</identifier><language>eng</language><publisher>Elsevier Ltd</publisher><subject>Asia ; Bronchodilation ; Chronic obstructive pulmonary disease ; Long-acting muscarinic antagonist ; Long-acting β2-agonist</subject><ispartof>Respiratory medicine, 2023-11, Vol.218, p.107393-107393, Article 107393</ispartof><rights>2023 The Authors</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c328t-f1356d2683efad72fcfc8630b9b0c7fe22eb7434a5539b30e9475b7aa68a1eb93</cites><orcidid>0000-0001-5049-6313 ; 0009-0002-2836-1994 ; 0000-0002-1530-3173</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://dx.doi.org/10.1016/j.rmed.2023.107393$$EHTML$$P50$$Gelsevier$$Hfree_for_read</linktohtml><link.rule.ids>315,781,785,3551,27926,27927,45997</link.rule.ids></links><search><creatorcontrib>Sun, Yongchang</creatorcontrib><creatorcontrib>Molins, Eduard</creatorcontrib><creatorcontrib>Daoud, Sami Z.</creatorcontrib><creatorcontrib>Trivedi, Roopa</creatorcontrib><creatorcontrib>Stewart, Catherine</creatorcontrib><creatorcontrib>Lamarca, Rosa</creatorcontrib><creatorcontrib>Bharali, Pranob</creatorcontrib><creatorcontrib>Garcia-Gil, Esther</creatorcontrib><title>Efficacy and safety of aclidinium/formoterol versus monotherapies and aclidinium versus placebo in Chinese and other Asian patients with moderate-to-severe COPD: The AVANT Phase 3 study</title><title>Respiratory medicine</title><description>AVANT was a Phase 3, 24-week, randomized, parallel-group, double-blind, double-dummy, placebo-controlled study to assess the efficacy and safety of aclidinium/formoterol 400 μg/12 μg combination vs monotherapies and aclidinium vs placebo (1:1:1:1) in Asian patients (∼70% of whom were Chinese) with moderate-to-severe stable chronic obstructive pulmonary disease. Endpoints were analyzed hierarchically to incorporate type I error control. At Week 24, aclidinium/formoterol demonstrated improvements from baseline in 1-h morning post-dose forced expiratory volume in 1 s (FEV1) vs aclidinium (least squares [LS] mean 92 mL; 95% confidence interval [CI] 60, 124 mL; p < 0.001), and in trough FEV1 vs formoterol (LS mean 85 mL; 95% CI 53, 117 mL; p < 0.001). Furthermore, aclidinium provided improvements in trough FEV1 vs placebo (LS mean 134 mL; 95% CI 103, 166 mL; p < 0.001). There was an improvement in transition dyspnea index focal score at Week 24 for aclidinium/formoterol vs placebo (LS mean 0.8; 95% CI 0.2, 1.3; p = 0.005) but not for aclidinium vs placebo (LS mean 0.4; 95% CI −0.1, 1.0; p = 0.132). Improvements in St George's Respiratory Questionnaire total scores occurred for aclidinium/formoterol vs placebo (LS mean −4.0; 95% CI −6.7, −1.4; p = 0.003) and aclidinium vs placebo (LS mean −2.9; 95% CI −5.5, −0.3; p = 0.031). Aclidinium/formoterol and aclidinium were well tolerated and safety findings were consistent with known profiles; rates of treatment-emergent adverse events (AEs) (aclidinium/formoterol: 54.8%; aclidinium: 47.4%; placebo: 53.9%), serious AEs (7.2, 7.9, and 7.8%, respectively), and AEs leading to discontinuation of study medication (2.3, 1.5, and 2.2%, respectively) were similar between groups.
•Aclidinium/formoterol and aclidinium knowledge is extended to Asian COPD patients.•Improvements in bronchodilation and QoL were clinically meaningful vs controls.•Treatment was well tolerated; safety findings were consistent with known profiles.</description><subject>Asia</subject><subject>Bronchodilation</subject><subject>Chronic obstructive pulmonary disease</subject><subject>Long-acting muscarinic antagonist</subject><subject>Long-acting β2-agonist</subject><issn>0954-6111</issn><issn>1532-3064</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><recordid>eNp9kctuEzEUhi0EEiHwAqy8ZDOpL3MzYhOFQitVbReBreWxjzWOZsaD7WmVR-PtcBIQu66OdPR_n3TOj9BHSjaU0PrqsAkjmA0jjOdFwwV_hVa04qzgpC5foxURVVnUlNK36F2MB0KIKEuyQr-vrXVa6SNWk8FRWUhH7C1WenDGTW4Zr6wPo08Q_ICfIMQl4tFPPvUQ1OwgnsH_8X-ZeVAaOo_dhHe9myDCOXjm8DY6NeFZJQdTivjZpT5LTTYmKJIvImQL4N3D49fPeN8D3v7c3u_xY6-yhuOYFnN8j95YNUT48Heu0Y9v1_vdTXH38P12t70rNGdtKizlVW1Y3XKwyjTMaqvbmpNOdEQ3FhiDril5qaqKi44TEGVTdY1SdasodIKv0aeLdw7-1wIxydFFDcOgJvBLlKytWtGKMn99jdglqoOPMYCVc3CjCkdJiTz1JA_y1JM89SQvPWXoywWCfMSTgyCjzm_RYFwAnaTx7iX8D-0Mn2c</recordid><startdate>202311</startdate><enddate>202311</enddate><creator>Sun, Yongchang</creator><creator>Molins, Eduard</creator><creator>Daoud, Sami Z.</creator><creator>Trivedi, Roopa</creator><creator>Stewart, Catherine</creator><creator>Lamarca, Rosa</creator><creator>Bharali, Pranob</creator><creator>Garcia-Gil, Esther</creator><general>Elsevier Ltd</general><scope>6I.</scope><scope>AAFTH</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><orcidid>https://orcid.org/0000-0001-5049-6313</orcidid><orcidid>https://orcid.org/0009-0002-2836-1994</orcidid><orcidid>https://orcid.org/0000-0002-1530-3173</orcidid></search><sort><creationdate>202311</creationdate><title>Efficacy and safety of aclidinium/formoterol versus monotherapies and aclidinium versus placebo in Chinese and other Asian patients with moderate-to-severe COPD: The AVANT Phase 3 study</title><author>Sun, Yongchang ; Molins, Eduard ; Daoud, Sami Z. ; Trivedi, Roopa ; Stewart, Catherine ; Lamarca, Rosa ; Bharali, Pranob ; Garcia-Gil, Esther</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c328t-f1356d2683efad72fcfc8630b9b0c7fe22eb7434a5539b30e9475b7aa68a1eb93</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Asia</topic><topic>Bronchodilation</topic><topic>Chronic obstructive pulmonary disease</topic><topic>Long-acting muscarinic antagonist</topic><topic>Long-acting β2-agonist</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Sun, Yongchang</creatorcontrib><creatorcontrib>Molins, Eduard</creatorcontrib><creatorcontrib>Daoud, Sami Z.</creatorcontrib><creatorcontrib>Trivedi, Roopa</creatorcontrib><creatorcontrib>Stewart, Catherine</creatorcontrib><creatorcontrib>Lamarca, Rosa</creatorcontrib><creatorcontrib>Bharali, Pranob</creatorcontrib><creatorcontrib>Garcia-Gil, Esther</creatorcontrib><collection>ScienceDirect Open Access Titles</collection><collection>Elsevier:ScienceDirect:Open Access</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Respiratory medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Sun, Yongchang</au><au>Molins, Eduard</au><au>Daoud, Sami Z.</au><au>Trivedi, Roopa</au><au>Stewart, Catherine</au><au>Lamarca, Rosa</au><au>Bharali, Pranob</au><au>Garcia-Gil, Esther</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Efficacy and safety of aclidinium/formoterol versus monotherapies and aclidinium versus placebo in Chinese and other Asian patients with moderate-to-severe COPD: The AVANT Phase 3 study</atitle><jtitle>Respiratory medicine</jtitle><date>2023-11</date><risdate>2023</risdate><volume>218</volume><spage>107393</spage><epage>107393</epage><pages>107393-107393</pages><artnum>107393</artnum><issn>0954-6111</issn><eissn>1532-3064</eissn><abstract>AVANT was a Phase 3, 24-week, randomized, parallel-group, double-blind, double-dummy, placebo-controlled study to assess the efficacy and safety of aclidinium/formoterol 400 μg/12 μg combination vs monotherapies and aclidinium vs placebo (1:1:1:1) in Asian patients (∼70% of whom were Chinese) with moderate-to-severe stable chronic obstructive pulmonary disease. Endpoints were analyzed hierarchically to incorporate type I error control. At Week 24, aclidinium/formoterol demonstrated improvements from baseline in 1-h morning post-dose forced expiratory volume in 1 s (FEV1) vs aclidinium (least squares [LS] mean 92 mL; 95% confidence interval [CI] 60, 124 mL; p < 0.001), and in trough FEV1 vs formoterol (LS mean 85 mL; 95% CI 53, 117 mL; p < 0.001). Furthermore, aclidinium provided improvements in trough FEV1 vs placebo (LS mean 134 mL; 95% CI 103, 166 mL; p < 0.001). There was an improvement in transition dyspnea index focal score at Week 24 for aclidinium/formoterol vs placebo (LS mean 0.8; 95% CI 0.2, 1.3; p = 0.005) but not for aclidinium vs placebo (LS mean 0.4; 95% CI −0.1, 1.0; p = 0.132). Improvements in St George's Respiratory Questionnaire total scores occurred for aclidinium/formoterol vs placebo (LS mean −4.0; 95% CI −6.7, −1.4; p = 0.003) and aclidinium vs placebo (LS mean −2.9; 95% CI −5.5, −0.3; p = 0.031). Aclidinium/formoterol and aclidinium were well tolerated and safety findings were consistent with known profiles; rates of treatment-emergent adverse events (AEs) (aclidinium/formoterol: 54.8%; aclidinium: 47.4%; placebo: 53.9%), serious AEs (7.2, 7.9, and 7.8%, respectively), and AEs leading to discontinuation of study medication (2.3, 1.5, and 2.2%, respectively) were similar between groups.
•Aclidinium/formoterol and aclidinium knowledge is extended to Asian COPD patients.•Improvements in bronchodilation and QoL were clinically meaningful vs controls.•Treatment was well tolerated; safety findings were consistent with known profiles.</abstract><pub>Elsevier Ltd</pub><doi>10.1016/j.rmed.2023.107393</doi><tpages>1</tpages><orcidid>https://orcid.org/0000-0001-5049-6313</orcidid><orcidid>https://orcid.org/0009-0002-2836-1994</orcidid><orcidid>https://orcid.org/0000-0002-1530-3173</orcidid><oa>free_for_read</oa></addata></record> |
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| subjects | Asia Bronchodilation Chronic obstructive pulmonary disease Long-acting muscarinic antagonist Long-acting β2-agonist |
| title | Efficacy and safety of aclidinium/formoterol versus monotherapies and aclidinium versus placebo in Chinese and other Asian patients with moderate-to-severe COPD: The AVANT Phase 3 study |
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