Effect of Gender on Lung Function and Patient-Reported Outcomes in Patients with COPD Receiving Nebulized Glycopyrrolate

Jill A Ohar1 Department of Internal Medicine, Wake Forest University, Winston-Salem, NC, USACorrespondence[email protected]

https://orcid.org/0000-0002-2757-6806

Ayca Ozol-Godfrey2 Sunovion Pharmaceuticals Inc., Marlborough, MA, USA

Thomas Goodin2 Sunovion Pharmaceuticals Inc., Marlborough, MA, USA

Shahin Sanjar2 Sunovion Pharmaceuticals Inc., Marlborough, MA, USA

https://orcid.org/0000-0003-1462-436X

Figures & data

Figure 1 GOLDEN 3 and GOLDEN 4 study designs: 12-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter studies.^Citation36

Notes: ^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 but were used in the modeling and in defining the gender subgroups studied in this analysis; inclusion of the 50 μg BID data in the modeling does not confound the interpretation of the GLY 25 μg BID dose.
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.

Table 1 Patient Demographics and Baseline Characteristics, by Gender

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Figure 2 Pooled analysis of trough FEV₁ at 12 weeks, by gender (ITT population).

Note: ***p<0.001 vs placebo.
Abbreviations: 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 trough FEV1 at 12 weeks, by gender (ITT population).

Figure 3 Pooled analysis of (A) SGRQ total score, (B) EXACT-RS total score at 12 weeks, by gender (ITT population).

Notes: **p<0.01 vs placebo; ^†p<0.01 vs male
Abbreviations: BID, twice daily; EXACT-RS, EXAcerbations of COPD Tool-Respiratory Symptoms; GLY, nebulized glycopyrrolate; ITT, intent-to-treat; LS, least squares; SE, standard error; SGRQ, St George’s Respiratory Questionnaire.

Figure 4 Pooled analysis of (A) SGRQ responder rates, (B) EXACT-RS responder rates at 12 weeks, by gender (ITT population).

Note: *p<0.05 vs placebo.
Abbreviations: BID, twice daily; CI, confidence interval; EXACT-RS, EXAcerbations of COPD Tool-Respiratory Symptoms; GLY, nebulized glycopyrrolate; ITT, intent-to-treat; OR, odds ratio; SGRQ, St George’s Respiratory Questionnaire.

Figure 5 Pooled analysis of rescue medication use over 12 weeks, by gender (ITT population).

Abbreviations: BID, twice daily; GLY, nebulized glycopyrrolate; ITT, intent-to-treat; LS, least squares; SE, standard error.

Table 2 Summary of AEs and SAEs, Including Individual AEs with Incidence ≥3% in Any Treatment Group, by Gender (Safety Population)

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Effect of Gender on Lung Function and Patient-Reported Outcomes in Patients with COPD Receiving Nebulized Glycopyrrolate

Table 1 Patient Demographics and Baseline Characteristics, by Gender

Table 2 Summary of AEs and SAEs, Including Individual AEs with Incidence ≥3% in Any Treatment Group, by Gender (Safety Population)

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Effect of Gender on Lung Function and Patient-Reported Outcomes in Patients with COPD Receiving Nebulized Glycopyrrolate

Figures & data

Table 1 Patient Demographics and Baseline Characteristics, by Gender

Table 2 Summary of AEs and SAEs, Including Individual AEs with Incidence ≥3% in Any Treatment Group, by Gender (Safety Population)

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