Symptom Improvement Following Treatment with the Inhaled Dual Phosphodiesterase 3 and 4 Inhibitor Ensifentrine in Patients with Moderate to Severe COPD – A Detailed Analysis

Figures & data

Table 1 E-RS™:COPD Subscales, TDI Focal Score, and SGRQ-C Total Score Responder Analyses at Week 4 (Full Analysis Set)

	Ensifentrine				Placebo (N=79)
	0.75 mg (N=81)	1.5 mg (N=81)	3 mg (N=82)	6 mg (N=80)
E-RS™:COPD
Breathlessness subscale, patients n/N (%)^a	28/71 (39.4)	28/74 (37.8)	26/76 (34.2)	21/74 (28.4)	11/76 (14.5)
Odds ratio vs placebo (95% CI); p value	3.77 (1.67, 8.47); 0.001	3.53 (1.58, 7.90); 0.002	3.02 (1.34, 6.77); 0.007	2.23 (0.97, 5.11); 0.059
Cough/sputum subscale, patientsn/N (%)^b	27/71 (38.0)	25/74 (33.8)	19/76 (25.0)	19/74 (25.7)	11/76 (14.5)
Odds ratio vs placebo (95% CI); p value	3.51 (1.57, 7.86); 0.002	2.94 (1.31, 6.57); 0.009	1.91 (0.83, 4.37); 0.127	1.96 (0.85, 4.52); 0.113
Chest symptoms subscale, patientsn/N (%)^b	22/71 (31.0)	23/74 (31.1)	23/76 (30.3)	23/74 (31.1)	12/76 (15.8)
Odds ratio vs placebo (95% CI); p value	2.39 (1.06, 5.37); 0.035	2.39 (1.07, 5.32); 0.033	2.29 (1.03, 5.10); 0.042	2.29 (1.02, 5.11); 0.044
TDI
Patients n/N (%)^c	42/77 (54.5)	43/80 (53.8)	44/80 (55.0)	43/78 (55.1)	22/77 (28.6)
Odds ratio vs placebo (95% CI); p value	3.23 (1.56, 6.69); 0.002	3.04 (1.49, 6.24); 0.002	3.36 (1.63, 6.92); 0.001	3.12 (1.51, 6.46); 0.002
SGRQ-C
Patients n/N (%)^d	38/74 (51.4)	31/75 (41.3)	22/71 (31.0)	32/77 (41.6)	20/73 (27.4)
Odds ratio vs placebo (95% CI); p value	2.62 (1.29, 5.29); 0.008	1.76 (0.87, 3.56); 0.119	1.11 (0.53, 2.31); 0.791	1.75 (0.86, 3.55); 0.123

Notes: Patients with ^a≥1 unit improvement, ^b≥0.7 unit improvement, ^cfocal score of 1, ^d4 unit improvement. Abbreviations: ERS:COPD™, Evaluating Respiratory Symptoms in COPD questionnaire; TDI, Transition Dyspnea Index; SGRQ-C, St George’s Respiratory Questionnaire – chronic obstructive pulmonary disease specific.

Figure 1 E-RS™:COPD: (A) total score; (B) breathlessness subscale; (C) cough/sputum subscale; (D) chest symptoms subscale (full analysis set). Panel 1A is reproduced from Singh D, Martinez FJ, Watz H, Bengtsson T, Maurer BT. A dose-ranging study of the inhaled dual phosphodiesterase 3 and 4 inhibitor ensifentrine in COPD. Respir Res. 2020;21(1):47. Creative commons license and disclaimer available from: (http://creativecommons.org/licenses/by/4.0/).¹¹ Data are least squares means treatment–placebo differences and 95% confidence intervals. *p<0.05; ^†p<0.01; ^‡p<0.001 vs placebo. Least squares mean changes from baseline in the placebo group (N=79) were 0.38, 0.57, 1.11 and 1.19 at Weeks 1, 2, 3 and 4, respectively for the total score, 0.11, 0.25, 0.53 and 0.47 for the breathlessness subscale, 0.14, 0.13, 0.30 and 0.36 for the cough/sputum subscale, and 0.12, 0.18, 0.26 and 0.35 for the chest symptoms subscale. Data analyzed for 71, 74, 76, 74 and 76 patients in the ensifentrine 0.75, 1.5, 3 and 6 mg and placebo groups, respectively.

Abbreviation: ERS:COPD™, Evaluating Respiratory Symptoms in COPD questionnaire.

Figure 2 TDI focal score at Weeks 2 and 4 (full analysis set). Data are least squares means treatment–placebo differences and 95% confidence intervals. *p<0.05; ^†p<0.01; ^‡p<0.001 vs placebo. Least squares mean TDI total scores in the placebo group (N=79) were 0.10 and 0.31 at Weeks 2 and 4, respectively. Data analyzed for 75, 80, 80, 78 and 76 patients in the ensifentrine 0.75, 1.5, 3 and 6 mg and placebo groups, respectively.

Abbreviation: TDI, Transition Dyspnea Index.

Figure 3 SGRQ-C total score and domains at Week 4 (full analysis set). Data are least squares means treatment–placebo differences and 95% confidence intervals. *p<0.05 vs placebo. Least squares mean changes from baseline in the placebo group (N=79) were –0.33, 1.25, –2.16 and 0.11 for the total score and the symptoms, activity and impacts domains, respectively. Data analyzed for 74, 75, 71, 77 and 73 patients in the ensifentrine 0.75, 1.5, 3 and 6 mg and placebo groups, respectively.

Abbreviation: SGRQ-C, St George’s Respiratory Questionnaire – chronic obstructive pulmonary disease specific.

SinghD, MartinezFJ, WatzH, BengtssonT, MaurerBT. A dose-ranging study of the inhaled dual phosphodiesterase 3 and 4 inhibitor ensifentrine in COPD. Respir Res. 2020;21(1):47. doi:10.1186/s12931-020-1307-432041601

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