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Table 1 Baseline characteristics

From: Long-term safety and exploratory efficacy of fevipiprant in patients with inadequately controlled asthma: the SPIRIT randomised clinical trial

 

Fevipiprant 150 mg N = 1092

Fevipiprant 450 mg N = 1084

Placebo N = 361

Total N = 2537

Demographic characteristics

 Age, years, mean (SD)

50.1 (14.95)

50.1 (15.55)

49.9 (14.99)

50.1 (15.21)

 Female sex, n (%)

659 (60.3)

666 (61.4)

229 (63.4)

1554 (61.3)

Disease characteristics

 Duration of asthma, years, n

1090

1084

361

2535

 Mean (SD)

21.01 (14.974)

21.03 (15.243)

19.75 (14.023)

20.84 (14.960)

 Number of asthma exacerbations in the previous year, n

1092

1084

361

2357

 Mean (SD)

1.39 (1.315)

1.41 (1.264)

1.45 (1.512)

1.41 (1.323)

 Atopic status—n (%)

    

  Yes

670 (61.4)

632 (58.3)

218 (60.4)

1520 (59.9)

  No

418 (38.3)

450 (41.5)

142 (39.3)

1010 (39.8)

  Missing

4 (0.4)

2 (0.2)

1 (0.3)

7 (0.3)

Prior participation in a fevipiprant phase 3 study, n (%)

 LUSTER-1/LUSTER-2

449 (41.1)

442 (40.8)

149 (41.3)

1040 (41.0)

  150 mg QD

254 (23.3)

53 (4.9)

51 (14.1)

358 (14.1)

  450 mg QD

48 (4.4)

241 (22.2)

47 (13.0)

336 (13.2)

  Placebo

148 (13.6)

148 (13.7)

50 (13.9)

346 (13.6)

 ZEAL-1/ZEAL-2

330 (30.2)

329 (30.4)

107 (29.6)

766 (30.2)

  150 mg QD

218 (20.0)

112 (10.3)

53 (14.7)

383 (15.1)

  Placebo

112 (10.3)

217 (20.0)

54 (15.0)

383 (15.1)

  Newly randomised

313 (28.7)

313 (28.9)

105 (29.1)

731 (28.8)

 Smoking history—n (%)

  Never

892 (81.7)

906 (83.6)

298 (82.5)

2096 (82.6)

  Former

200 (18.3)

178 (16.4)

63 (17.5)

441 (17.4)

 Blood eosinophil at screening—n (%)

  ˂250 cells/μL

434 (39.7)

427 (39.4)

149 (41.3)

1010 (39.8)

  ≥ 250 cells/μL

635 (58.2)

641 (59.1)

202 (56.0)

1478 (58.3)

  Missing

23 (2.1)

16 (1.5)

10 (2.8)

49 (1.9)

Baseline spirometry

 Percent predicted FEV1 (%) (Pre-bronchodilator)

    

  n

1079

1069

354

2502

  Mean

61.0

60.5

60.9

60.8

  SD

13.86

13.98

14.37

13.98

 FEV1 reversibility (%)

    

  n

1069

1064

353

2486

  Mean

21.9

22.9

24.0

22.6

  SD

17.97

18.82

16.56

18.16

  1. Age is calculated from date of screening and July 1st of the year of birth for adults. For adolescents, age is collected directly from Electronic Case Report Form (eCRF)
  2. For all other variables, prior study baseline is used as the baseline value in patients who completed a prior Phase 3 study, and SPIRIT baseline is used as the baseline value in new patients
  3. Duration of asthma is calculated as date of asthma first diagnosed until Visit 1. Blood eosinophil count at screening visit of prior study is considered for rollover patients. FEV1 reversibility is calculated as increase of FEV1 value after inhalation of bronchodilator relative to the FEV1 value before inhalation of bronchodilator. Reversible: increase of FEV1 value ≥ 12% and ≥ 200 mL Not reversible: change of FEV1 value < 12% or < 200 mL. FEV1 reversibility demonstrated at clinic at Visit 1 are presented. Percent predicted FEV1: percentage of FEV1 relative to the predicted normal value. For patients who completed a prior Phase 3 study, prior study baseline is used as the baseline value
  4. BMI body mass index; FEV1 forced expiratory volume in one second; SD standard deviation
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Respiratory Research

ISSN: 1465-993X

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