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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 (%)
 White3944 (79.1)958 (76.9)2653 (86.1)
 Asian711 (14.3)203 (16.3)192 (6.2)
 Black302 (6.1)80 (6.4)218 (7.1)
 Other26 (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 exacerbation1246 (25.0)1246 (100.0)823 (26.7)
  ≥1 severe exacerbation302 (6.1)302 (24.2)211 (6.8)
COPD severity, n (%)
 Mildd30 (0.6)6 (0.5)8 (0.3)
 Moderate2764 (55.5)619 (49.7)1558 (50.6)
 Severe1971 (39.6)551 (44.2)1344 (43.6)
 Very severe218 (4.4)70 (5.6)172 (5.6)
GOLD 2017 Category, n (%)
 A729 (14.6)105 (8.4)0
 B3693 (74.1)591 (47.4)2705 (87.8)
 C73 (1.5)73 (5.9)0
 D473 (9.5)473 (38.0)377 (12.2)
 Missing15 (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)f50.8 (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)f79.5 (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