Skip to main content

Table 1 Patient demographics and clinical characteristics (pooled ITT, exacerbation history, and CAT ≥15 populations)

From: Benefits of glycopyrrolate/formoterol fumarate metered dose inhaler (GFF MDI) in improving lung function and reducing exacerbations in patients with moderate-to-very severe COPD: a pooled analysis of the PINNACLE studies

 

Pooled ITT

(n = 4983)

Exac. historya

(n = 1246)

CAT ≥15

(n = 3082)

Mean age, years (SD)

63.3 (8.1)

62.8 (8.1)

62.1 (8.2)

Age ≥65 years, n (%)

2339 (46.9)

551 (44.2)

1243 (40.3)

Male, n (%)

3086 (61.9)

705 (56.6)

1774 (57.6)

Race, n (%)

 White

3944 (79.1)

958 (76.9)

2653 (86.1)

 Asian

711 (14.3)

203 (16.3)

192 (6.2)

 Black

302 (6.1)

80 (6.4)

218 (7.1)

 Other

26 (0.5)

5 (0.4)

19 (0.6)

Current smoker, n (%)

2528 (50.7)

588 (47.2)

1824 (59.2)

Mean number of pack-years smokedb (SD)

49.3 (26.1)

48.6 (25.8)

50.7 (26.3)

Mean number of years smoked (SD)

39.4 (10.3)

38.8 (10.3)

40.2 (9.9)

Mean total CAT scorec (SD)

17.3 (7.5)

18.1 (7.6)

22.0 (5.2)

 CAT ≥10, n (%)

4166 (83.6)

1064 (85.4)

3082 (100.0)

 CAT ≥15, n (%)

3082 (61.9)

823 (66.1)

3082 (100.0)

 CAT ≥20, n (%)

1879 (37.7)

519 (41.7)

1879 (61.0)

ICS use at baseline, n (%)

1723 (34.6)

589 (47.3)

1104 (35.8)

Exacerbation history in the past year, n (%)

  ≥1 moderate or severe exacerbation

1246 (25.0)

1246 (100.0)

823 (26.7)

  ≥1 severe exacerbation

302 (6.1)

302 (24.2)

211 (6.8)

COPD severity, n (%)

 Mildd

30 (0.6)

6 (0.5)

8 (0.3)

 Moderate

2764 (55.5)

619 (49.7)

1558 (50.6)

 Severe

1971 (39.6)

551 (44.2)

1344 (43.6)

 Very severe

218 (4.4)

70 (5.6)

172 (5.6)

GOLD 2017 Category, n (%)

 A

729 (14.6)

105 (8.4)

0

 B

3693 (74.1)

591 (47.4)

2705 (87.8)

 C

73 (1.5)

73 (5.9)

0

 D

473 (9.5)

473 (38.0)

377 (12.2)

 Missing

15 (0.3)

4 (0.3)

0

Mean COPD duration, yearse (SD)

7.2 (6.3)

7.4 (6.1)

7.6 (6.4)

Mean pre-bronchodilator FEV1, % predicted (SD)

45.1 (13.8)

43.2 (13.6)

43.5 (13.7)

Mean post-bronchodilator FEV1, % predicted (SD)

52.5 (13.9)f

50.8 (14.0)

50.9 (13.9)

Mean pre-bronchodilator FVC, % predicted (SD)

71.2 (16.2)

70.0 (15.9)

68.6 (15.7)

Mean post-bronchodilator FVC, % predicted (SD)

80.0 (16.3)f

79.5 (16.3)

77.5 (15.8)

  1. aThe exacerbation history population includes patients with ≥1 moderate or severe exacerbation in the previous year
  2. bPack-years smoked = (number of cigarettes per day/20)* number of years smoked
  3. cn = 4968 (pooled ITT), n = 1242 (Exac. history)
  4. dCharacterized as mild COPD due to the application of an Asian correction factor in PINNACLE-4, and were identified as protocol deviations
  5. en = 4970 (pooled ITT), n = 1243 (Exac. history), n = 3076 (CAT ≥15)
  6. fn = 4981
  7. CAT COPD assessment test, COPD chronic obstructive pulmonary disease, Exac. exacerbation, FEV1 forced expiratory volume in 1 s, FVC forced vital capacity, GOLD Global Initiative for Chronic Obstructive Lung Disease, ICS inhaled corticosteroid, ITT intent-to-treat, SD standard deviation
Back to article page

Respiratory Research

ISSN: 1465-993X

Contact us