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Table 1 Patient demographics and baseline characteristics (mITT population)

From: 24-h bronchodilation and inspiratory capacity improvements with glycopyrrolate/formoterol fumarate via co-suspension delivery technology in COPD

 

PT003011

PT003012

GFF MDI

18/9.6 μg

(n = 73)

Placebo

MDI

(n = 69)

TIO SMI

5 μg

(n = 73)

GFF MDI

18/9.6 μg

(n = 35)

Placebo

MDI

(n = 35)

Mean age, years (SD)

61.9 (9.1)

61.7 (9.1)

61.9 (8.9)

61.3 (9.2)

61.3 (9.2)

Male, n (%)

26 (35.6)

24 (34.8)

27 (37.0)

20 (57.1)

20 (57.1)

White, n (%)

66 (90.4)

63 (91.3)

66 (90.4)

27 (77.1)

27 (77.1)

Current smokers, n (%)

45 (61.6)

43 (62.3)

45 (61.6)

20 (57.1)

20 (57.1)

Mean smoking history, pack-years (SD)

56.4 (29.2)

57.6 (29.3)

55.9 (29.3)

49.0 (25.2)

49.0 (25.2)

Use of ICS at baseline, n (%)

23 (31.5)

20 (29.0)

22 (30.1)

10 (28.6)

10 (28.6)

COPD severity, n (%)

 Moderate

53 (72.6)

47 (68.1)

51 (69.9)

20 (57.1)

20 (57.1)

 Severe

20 (27.4)

22 (31.9)

22 (30.1)

14 (40.0)

14 (40.0)

 Very severe

0

0

0

1 (2.9)

1 (2.9)

Mean COPD duration, years (SD)

6.8 (5.9)

7.2 (6.1)

7.1 (6.0)

6.3 (4.7)

6.3 (4.7)

Mean pre-bronchodilator FEV1

 mL (SD)

1410 (461)

1396 (466)

1414 (460)

1406 (542)

1406 (542)

 % predicted (SD)

52.54 (13.97)

51.70 (14.20)

52.33 (14.11)

48.34 (16.20)

48.34 (16.20)

Mean post-bronchodilator FEV1

 mL (SD)

1542 (435)

1521 (434)

1546 (434)

1525 (538)

1525 (538)

 % predicted (SD)

57.69 (13.50)

56.61 (13.61)

57.44 (13.68)

52.51 (15.35)

52.51 (15.35)

Baseline ICa, mL (SD)

1877 (527)

1913 (560)

1925 (546)

1979 (656)

1942 (632)

Average daily rescue medication use at baselineb, puffs/day (SD)

2.5 (3.5)

2.6 (3.7)

2.6 (3.6)

3.4 (3.4)

3.4 (3.4)

Patients with a moderate or severe COPD exacerbationc within the past 12 monthsd, n (%)

13 (17.3)

12 (16.7)

12 (16.4)

10 (25.0)

10 (25.0)

Patients hospitalized/ER room treatment within the past 12 monthsd, n (%)

4 (5.3)

5 (6.9)

5 (6.8)

0

0

  1. COPD chronic obstructive pulmonary disease, FEV 1 forced expiratory volume in 1 s, GFF glycopyrrolate/formoterol fumarate, IC inspiratory capacity, ICS inhaled corticosteroids, MDI metered dose inhaler, mITT modified intent-to-treat, SD standard deviation, SMI Soft Mist™ inhaler, TIO open-label tiotropium
  2. aBaseline IC was defined as the mean of the pre-dose values on the first day of each treatment period, where the mean of the 30- and 60-min values for each visit day was obtained, and then the visit means were averaged
  3. bBaseline rescue medication use was defined as the average daily number of puffs used over the 7 days prior to the date of first dose in Treatment Period 1
  4. cA COPD exacerbation was defined as a change in the subject’s baseline dyspnea, cough, and/or sputum (increase in volume or change in color towards purulence) that lasted ≥3 days, was beyond normal day to day variations, was acute in onset, and may have warranted a change in regular medication
  5. dSafety population. PT003011: GFF MDI, n = 75; Placebo MDI, n = 72; TIO SMI, n = 73. PT003012: GFF MDI, n = 40; Placebo MDI, n = 40
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Respiratory Research

ISSN: 1465-993X

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