Phase 4
Completed N=1,053
Evaluation of the Efficacy and Safety of QVA149 (110/50 μg o.d.) vs Tiotropium (18 µg o.d.) + Salmeterol/Fluticasone Propionate FDC (50/500 µg b.i.d.) in Patients With Moderate to Severe COPD
Source: ClinicalTrials.gov NCT02603393 ↗Enrolled (actual)
1,053
Serious AEs
6.3%
Results posted
Apr 2019
Primary outcomePrimary: Mean Change From Baseline in Post-dose Trough FEV1 — -0.029; -0.003 Liters — p=0.0404
◆ Published Evidence
Highly cited
261citations · ~33 / year
Long-Term Triple Therapy De-escalation to Indacaterol/Glycopyrronium in Patients with Chronic Obstructive Pulmonary Disease (SUNSET): A Randomized, Double-Blind, Triple-Dummy Clinical Trial.
Summary
This study will evaluate the efficacy and safety of QVA149 (110/50 μg o.d.) vs tiotropium (18 µg o.d.) + salmeterol/fluticasone propionate FDC (50/500 µg b.i.d.) in patients with moderate to severe COPD
Linked Publications
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Long-Term Triple Therapy De-escalation to Indacaterol/Glycopyrronium in Patients with Chronic Obstructive Pulmonary Disease (SUNSET): A Randomized, Double-Blind, Triple-Dummy Clinical Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Change From Baseline in Post-dose Trough FEV1 |
-0.029; -0.003 | 0.0404 sig |
| SECONDARY Annualized Rate of Moderate or Severe COPD Exacerbations |
0.52; 0.48 | 0.5802 |
| SECONDARY Annualized Rate of COPD Exacerbations Requiring Treatment With Systemic Glucocorticosteroids and/or Antibiotics, Moderate Exacerbations Only |
0.47; 0.44 | 0.5651 |
| SECONDARY Annualized Rate of COPD Exacerbations Requiring Hospitalisation |
0.001; 0.001 | 0.9665 |
| SECONDARY Mean Change From Baseline in Pre-dose Trough FEV1 |
-0.029; -0.003 | 0.0573 |
| SECONDARY Mean Change From Baseline in St. George's Respiratory Questionnaire |
-1.0; -2.5 | 0.0221 sig |
| SECONDARY Mean Change From Baseline in St. George's Respiratory Questionnaire |
-1.0; -2.5 | 0.0221 sig |
| SECONDARY Transition Dyspnea Index (TDI) Score |
1.382; 1.671 | 0.1055 |
| SECONDARY Transition Dyspnea Index (TDI) Score |
1.382; 1.671 | 0.1055 |
| SECONDARY Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication |
-0.307; -0.484 | 0.0641 |
| SECONDARY Mean Change From Baseline in Forced Vital Capacity (FVC) |
-0.030; -0.048 | 0.4107 |
Eligibility Criteria
Inclusion Criteria
- Patients who have signed Informed Consent Form prior to initiation of any study-related procedure.
- Male and female adults aged ≥ 40 years.
- Patients with moderate to severe airflow obstruction with stable COPD (Stage 2 or Stage 3) according to the 2014 GOLD Guidelines.
- Patients with a post-bronchodilator FEV1 ≥40 and < 80% of the predicted normal value, and post-bronchodilator FEV1/FVC < 0.70 at run-in Visit 101. (Post refers to 15 min after inhalation of 400 µg of salbutamol).
- Current or ex-smokers who have a smoking history of at least 10 pack years (e.g. 10 pack years = 1 pack /day x 10 years, or ½ pack/day x 20 years). An ex-smoker is defined as a patient who has not smoked for ≥ 6 months at screening.
- Patients who are on triple treatment at least for the last 6 months (LAMA +LABA/ICS).
Exclusion Criteria
- Patients who have not achieved acceptable spirometry results at Visit 101 in accordance with ATS (American Thoracic Society)/ERS (European Respiratory Society) criteria for acceptability (one retest may be performed for patients that don't meet the acceptability criteria) .
- Patients who have had more than one COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the last year prior to Visit 1.
- Patients who developed a COPD exacerbation of any severity either 6 weeks before the screening (Visit 1) or between screening (Visit 1) and treatment (Visit 201) will not be eligible but will be permitted to be re-screened after a minimum of 6 weeks after the resolution of the COPD exacerbation.
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT02603393) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.