Table 5.
Important ongoing or recently completed clinical trials assessing fixed dose combination dual bronchodilators
| Fixed dose combination | Identifier and study name | Comparator | Patients | n | Evaluation |
|---|---|---|---|---|---|
| QVA149 | NCT01709903* LANTERN | Salmeterol/fluticasone 500/50 μg twice daily | Moderate to severe COPD | 679 | QVA149 vs. SFC for lung function and rate of exacerbations |
| NCT01574651† QUANTIFY | Tiotropium 18 μg once daily plus formoterol 12 mg twice daily | Moderate to severe COPD | 934 | QVA149 vs. LABA and LAMA co-prescribing for lung function and dyspnoea | |
| UMEC/VI | NCT01822899‡ | Salmeterol/fluticasone twice daily | Moderate to severe COPD without recent history of exacerbation | 716 | UMEC/VI vs. SFC for lung function |
| NCT02014480¶ | Crossover study, | COPD | 389 | Effect of UMEC/VI vs. mono-components in responders/non-responders | |
| and | UMEC 62.5 μg once daily, | ||||
| NCT01716520 | VI 25 μg once daily | ||||
| Tiotropium/olodaterol | NCT01525615§ TORRACTO | Placebo | Moderate to severe COPD | 404 | Impact on exercise tolerance vs. placebo |
| NCT01431274** (TONADO 1) | O 5 μg, T 2.5 μg, T 5 μg, T + O 2.5/5 μg or T + O 5/5 μg | Moderate to very severe COPD | 5162 | T + O 5/5 μg vs. monotherapy for lung function and symptoms | |
| and | |||||
| NCT01431287†† (TONADO 2) | |||||
| FF/UMEC/VI | NCT02164513‡‡ IMPACT | FF/UMEC/VI 100/62.5/25 μg, FF/VI 100/25 μg or UMEC/VI 62.5/25 μg | COPD with CAT score >10 | 10,000 | Superiority of triple therapy over dual therapy for moderate/severe exacerbations |
Clinicaltrials.gov. A 26 week treatment randomized, double-blind, double dummy study to assess the efficacy and safety of QVA149 (LANTERN). NCT01709903. http://clinicaltrials.gov/ct2/show/NCT01709903 [Accessed 23 Sept 2014].
ClinicalTrials.gov. The Effect of QVA149 on Health Related Quality of Life in Patients With Chronic Obstructive Pulmonary Disease (COPD) (QUANTIFY). http://clinicaltrials.gov/ct2/show/NCT01574651 [Accessed 22 Sept 2014].
ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Umeclidinium Bromide/Vilanterol Compared With Fluticasone Propionate/Salmeterol Over 12 Weeks in Subjects With Chronic Obstructive Pulmonary Disease (COPD). http://clinicaltrials.gov/ct2/show/NCT01822899 [Accessed 22 Sept 2014].
ClinicalTrials.gov. A Cross-Over Study to Evaluate Lung Function Response After Treatment With Umeclidinium (UMEC) 62.5 Micrograms (Mcg), Vilanterol (VI) 25 Mcg, and Umeclidinium/Vilanterol (UMEC/VI) 62.5/25 Mcg Once-Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD). http://clinicaltrials.gov/ct2/show/NCT02014480 [Accessed 22 Sept 2014].
ClinicalTrials.gov. A Study to Determine the Effect of Tiotropium + Olodaterol Fixed Dose Combination on Exercise Endurance Time During Constant Work Load Cycle Test in COPD. http://clinicaltrials.gov/ct2/show/NCT01525615 [Accessed 22 Sept 2014].
ClinicalTrials.gov. Tiotropium + Olodaterol Fixed Dose Combination (FDC) Versus Tiotropium and Olodaterol in Chronic Obstructive Pulmonary Disease (COPD). http://clinicaltrials.gov/ct2/show/NCT01431274 [Accessed 22 Sept 2014].
ClinicalTrials.gov. Tiotropium + Olodaterol Fixed Dose Combination (FDC) Versus Tiotropium and Olodaterol in Chronic Obstructive Pulmonary Disease (COPD). http://clinicaltrials.gov/ct2/show/NCT01431287 [Accessed 22 Sept 2014].
ClinicalTrials.gov. A Study Comparing the Efficacy, Safety and Tolerability of Fixed Dose Combination (FDC) of FF/UMEC/VI With the FDC of FF/VI and UMEC/VI; Administered Once-daily Via a Dry Powder Inhaler (DPI) in Subjects With Chronic Obstructive Pulmonary Disease (COPD) http://clinicaltrials.gov/ct2/show/NCT02164513 [Accessed 22 Sept 2014].