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

Novartis

Status and phase: Completed; Phase 4

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: Tiotropium; Drug: QVA149; Drug: Salmeterol/fluticasone

Study type: Interventional

Funder types: Industry

Identifiers

NCT02603393

2015-000114-22 (EudraCT Number)

CQVA149A2316

Details and patient eligibility

About

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

Enrollment: 1,053 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

1,053 participants in 2 patient groups

QVA149

Experimental group

Treatment:

Drug: QVA149

Tiotropium + salmeterol/fluticasone

Active Comparator group

Treatment:

Drug: Tiotropium

Drug: Salmeterol/fluticasone