Table 4.
Exacerbations And CIDa (China ITT Population)
| GFF MDI 18/9.6 µg n=146 |
GP MDI 18 µg n=122 |
FF MDI 9.6 µg n=135 |
Placebo MDI n=63 |
|
|---|---|---|---|---|
| Exacerbations | ||||
| Patients with a moderate or severe exacerbation | ||||
| n (%) | 22 (15.1) | 23 (18.9) | 31 (23.0) | 15 (23.8) |
| Time to first moderate or severe COPD exacerbation | ||||
| GFF MDI vs monocomponents and placebo MDI | ||||
| Hazard ratio | NA | 0.71 | 0.57 | 0.57 |
| 95% CI | NA | 0.39, 1.28 | 0.33, 1.00 | 0.29, 1.10 |
| P-value | NA | 0.2543 | 0.0501 | 0.0950 |
| Rate of moderate or severe COPD exacerbations (per year)b | ||||
| Rate | 0.44 | 0.47 | 0.62 | 0.65 |
| Model-estimated rate | 0.38 | 0.46 | 0.58 | 0.60 |
| GFF MDI vs monocomponents and placebo MDI | ||||
| Model-estimated rate ratio | NA | 0.82 | 0.65 | 0.63 |
| 95% CI | NA | 0.46, 1.49 | 0.38, 1.12 | 0.32, 1.22 |
| P-value | NA | 0.5200 | 0.1224 | 0.1689 |
| CID | ||||
| Patients with a CID | ||||
| n (%) | 73 (50.0) | 80 (65.6) | 77 (57.0) | 51 (81.0) |
| Median time to CIDc (weeks) | 24.1 | 16.3 | 16.1 | 12.0 |
| Time to first CID | ||||
| GFF MDI vs monocomponents and placebo MDI | ||||
| Hazard ratio | NA | 0.65 | 0.71 | 0.36 |
| 95% CI | NA | 0.47, 0.90 | 0.52, 0.99 | 0.25, 0.52 |
| P-value | NA | 0.0095 | 0.0428 | <0.0001 |
Notes: aCID is defined as the first occurrence of one of the following events: ≥100 mL decline in trough FEV1; a treatment-emergent moderate or severe COPD exacerbation; or ≥4-unit increase in SGRQ total score. bRate of exacerbations per year = total number of exacerbations/total years of exposure across all patients for the treatment. cTime to CID (weeks) = (date of CID – first treatment administration date + 1)/7. All p-values <0.05 should only be interpreted in terms of nominal significance as the analyses in the Chinese subgroup were considered exploratory.
Abbreviations: CI, confidence interval; CID, clinically important deterioration; COPD, chronic obstructive pulmonary disease; FEV1, forced expiratory volume in 1 second; FF, formoterol fumarate; GFF, glycopyrrolate/formoterol fumarate; GP, glycopyrrolate; ITT, intent-to-treat; MDI, metered dose inhaler; NA, not applicable; SGRQ, St George’s Respiratory Questionnaire.