Table 3.
Summary of the efficacy results of triple therapy versus LABA/ICS.
| BDP/FOR/GB | FF/UMEC/VI | BUD/FOR/GB | Open triples | ||
|---|---|---|---|---|---|
| Lung function | Trough FVC (ml) | – | – | – | NS to 243 (178, 308) |
| Trough FEV1 (mL) | 63 (32, 94) | 97 (85, 109) to 171 (148, 194) | 74 (47, 102)‡ | NS to 147 | |
| Trough FEV1 ⩾100 ml (OR) | 2.06 (1.62, 2.62) | 4.03 (3.27, 4.97) | – | 4.1 to 5.6 | |
| FEV1 5 min post morning dose (ml) | – | – | – | – | |
| Peak FEV1 (ml) | – | – | – | 90 (not reported) to 186 (145, 226) | |
| FEV1 AUC0-24 | – | – | – | – | |
| Total lung capacity (ml) | – | – | – | NS to 105 (12, 221)$ | |
| Forced residual capacity (ml) | – | – | – | NS | |
| Residual volume (ml) | – | – | – | NS to 189 (46, 332) $ | |
| IC (ml) | – | – | – | NS to 58 (not reported) | |
| Symptoms | Dyspnea (TDI) | NS | – | – | NS |
| TDI increase ⩾1 point (OR) | NS | 1.36 (1.19, 1.55) | – | – | |
| HRQL (SGRQ) | −1.69 (–3.20, –0.17) | −1.8 (−2.4, −1.1) to −2.2 (−1.0, −3.5) | – | NS to −2.16 (−0.49, −3.83) | |
| SGRQ increase ⩾4 points (%) | – | – | – | – | |
| SGRQ increase ⩾4 points (OR) | 1.33 (1.06, 1.66) | 1.41 (1.29, 1.55) to 1.41 (1.16, 1.70)* | NS | NS to 2.01 (1.28, 3.14) | |
| Rescue medication (puffs/day) | NS | – | NS | NS to −0.72 (−1.08, −0.34) | |
| Rescue medication (% days without) | NS | – | – | NS to 8.1 (3.6, 12.6) | |
| Exacerbations | Number of all exacerbations (RR) | – | 0.65 | – | – |
| Time to first exacerbation, all (HR) | – | – | – | ||
| Number of moderate-to-severe exacerbations (RR) | 0.77 (0.65, 0.92) | 0.65 (0.49, 0.86) to 0.85 (0.80, 0.90) | NS | NS | |
| Time to first moderate-to-severe exacerbation (HR) | 0.80 (0.67, 0.97) | 0.85 (0.80, 0.90) | NS | – |
Results expressed as point estimates with 95% CI in parentheses when reported. *Both trials FULFIL and IMPACT reported the same point estimates with different confidence intervals. $97.5% confidence interval reported. ‡p value <0.0001, but referred to as nominally significant which denotes p < 0.05 but not statistically significant after type I error control or not included in the type I error control strategy.19
BDP/FOR/GB, fixed dose combination of beclomethasone, formoterol, and glycopyrronium; FEV1, forced expiratory volume in the first second; FF/UMEC/VI, fixed dose combination of fluticasone furoate, umeclidinium, and vilanterol; FVC, forced volume capacity; HR, hazard ratio; HRQL, health-related quality of life; IC, inspiratory capacity; ICS, inhaled corticosteroids; LABA, long-acting ß2 agonist; NS, not significant; OR, odds ratio; RR, risk ratio; SGRQ, St. George’s Respiratory Questionnaire; TDI, transitional dyspnea index.