Table 2.
Summary of the efficacy results of triple therapy versus LABA/LAMA.
| BDP/FOR/GB | FF/UMEC/VI | BUD/FOR/GB | Open triples | ||
|---|---|---|---|---|---|
| Lung function | Trough FVC (ml) | NS | – | – | – |
| Trough FEV1 (ml) | NS | 54 (39, 69) | NS | NS | |
| Trough FEV1 ⩾100 ml (OR) | NS | – | – | – | |
| FEV1 5 min post morning dose (ml) | – | – | – | – | |
| Peak FEV1 (ml) | – | – | – | – | |
| FEV1 AUC0-24 | – | – | – | – | |
| Total lung capacity (ml) | – | – | – | – | |
| Forced residual capacity (ml) | – | – | – | – | |
| Residual volume (ml) | – | – | – | – | |
| IC (ml) | – | – | – | – | |
| Symptoms | Dyspnea (TDI) | – | – | – | – |
| TDI increase ⩾1 point (OR) | – | 1.33 (1.13, 1.57) | – | – | |
| HRQL (SGRQ) | −1.68 (not reported) | −1.8 (–2.4, –1.1) |
– | NS | |
| SGRQ increase ⩾4 points (%) | – | – | – | – | |
| SGRQ increase ⩾4 points (OR) | NS | 1.41 (1.29, 1.55) | 1.28 (1.01, 1.61)* | – | |
| Rescue medication (puffs/day) | NS | – | NS | – | |
| Rescue medication (days without) | NS | – | – | – | |
| Exacerbations | Number of all exacerbations (RR) | – | – | – | NS |
| Time to first exacerbation, all (HR) | – | – | – | – | |
| Number of moderate-to-severe exacerbations (RR) | 0.84 (0.72, 0.99) | 0.75 (0.70, 0.81) | 0.48 (0.37, 0.64) | – | |
| Time to first moderate-to-severe exacerbation (HR) | NS | 0.84 (0.79, 0.89) | 0.59 (not reported) | – |
Results expressed as point estimates with 95% CI in parentheses when reported. *p value of 0.04, 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 vital capacity; HR, hazard ratio; HRQL, health-related quality of life; IC, inspiratory capacity; LABA, inhaled long-acting ß2 agonist; LAMA, long-acting muscarinic antagonist; NS, not significant; OR, odds ratio; RR, risk ratio; SGRQ, St. George’s Respiratory Questionnaire; TDI, transitional dyspnea index.