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International Journal of Chronic Obstructive Pulmonary Disease Volume 16, 2021 - Issue
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Original Research

Improvement in Lung Function and Patient-Reported Outcomes in Patients with COPD with Comorbid Anxiety and Depression Receiving Nebulized Glycopyrrolate in the GOLDEN 3 and 4 Studies

Nicola A Hanania1 Section of Pulmonary, Critical Care and Sleep Medicine, Baylor College of Medicine, Houston, TX, 77030, USACorrespondence[email protected]
,
Abebaw M Yohannes2 Department of Physical Therapy, Azusa Pacific University, Azusa, CA, USAORCID Iconhttps://orcid.org/0000-0002-8341-270X
ORCID Icon,
Ayca Ozol-Godfrey3 Sunovion Pharmaceuticals Inc., Marlborough, MA, USA
,
Michael Tocco3 Sunovion Pharmaceuticals Inc., Marlborough, MA, USA
,
Thomas Goodin3 Sunovion Pharmaceuticals Inc., Marlborough, MA, USA
,
Sanjay Sharma3 Sunovion Pharmaceuticals Inc., Marlborough, MA, USAORCID Iconhttps://orcid.org/0000-0001-5232-3272
ORCID Icon &
Shahin Sanjar3 Sunovion Pharmaceuticals Inc., Marlborough, MA, USAORCID Iconhttps://orcid.org/0000-0003-1462-436X
ORCID Icon show all
Pages 865-875 | Published online: 31 Mar 2021

Figures & data

Figure 1 GOLDEN 3 and 4 study designs.

Notes: Data from Kerwin et al.Citation17 aSAEs were monitored for 30 days after the last dose of study treatment. bData for the GLY 50 µg BID treatment arm are not presented in this post hoc analysis.
Abbreviations: BID, twice daily; CS, closed system; GLY, nebulized glycopyrrolate; ICS, inhaled corticosteroids; LABA, long-acting β2-agonist; min, minimum; SAE, serious adverse event; tx, treatment.
Figure 1 GOLDEN 3 and 4 study designs.

Table 1 Patient Distribution by Baseline Comorbid Anxiety and Depression Status

Table 2 Patient Demographics and Baseline Characteristics by Baseline Comorbid Anxiety and Depression Status

Figure 2 Pooled analysis of change from baseline in trough FEV1 at 12 weeks, by baseline comorbid anxiety and depression status (ITT population).

Notes: ****p<0.0001 vs Placebo. The n values represent the number of patients with on-treatment data at Week 12.
Abbreviations: A/D (+), comorbid anxiety and depression; A/D (–), no comorbid anxiety and depression, or anxiety or depression alone; BID, twice daily; FEV1, forced expiratory volume in 1 second; GLY, nebulized glycopyrrolate; ITT, intent-to-treat; LS, least squares; SE, standard error.
Figure 2 Pooled analysis of change from baseline in trough FEV1 at 12 weeks, by baseline comorbid anxiety and depression status (ITT population).

Figure 3 Pooled analysis of SGRQ change from baseline in (A) total score, (B) activity score, (C) impacts score, and (D) symptoms score at 12 weeks, by baseline comorbid anxiety and depression status (ITT population).

Notes: *p<0.05; **p<0.01; ***p<0.001 vs placebo. The n values represent the number of patients with on-treatment data at Week 12.
Abbreviations: A/D (+), comorbid anxiety and depression; A/D (–), no comorbid anxiety and depression, or anxiety or depression alone; BID, twice daily; GLY, nebulized glycopyrrolate; ITT, intent-to-treat; LS, least squares; SE, standard error; SGRQ, St George’s Respiratory Questionnaire.
Figure 3 Pooled analysis of SGRQ change from baseline in (A) total score, (B) activity score, (C) impacts score, and (D) symptoms score at 12 weeks, by baseline comorbid anxiety and depression status (ITT population).

Figure 4 SGRQ responder rates at 12 weeks, by baseline comorbid anxiety and depression status (ITT population).

Notes: **p<0.01 vs placebo. The n values represent the number of patients with on-treatment data at Week 12.
Abbreviations: A/D (+), comorbid anxiety and depression; A/D (–), no comorbid anxiety and depression, or anxiety or depression alone; BID, twice daily; CI, confidence interval; GLY, nebulized glycopyrrolate; ITT, intent-to-treat; OR, odds ratio; SGRQ, St George’s Respiratory Questionnaire.
Figure 4 SGRQ responder rates at 12 weeks, by baseline comorbid anxiety and depression status (ITT population).

Table 3 Summary of AEs and SAEs, Including Individual AEs with Incidence ≥5% in Any Treatment Group, by Baseline Comorbid Anxiety and Depression Status (Safety Population)

 

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