Lung Function and Patient Preference With QVA149 vs. Tiotropium in COPD Patients (FAVOR)

Novartis

Status and phase

Completed

Phase 4

Conditions

Chronic Obstructive Pulmonary Disease

COPD

Treatments

Drug: QVA149

Drug: Tiotropium

Study type

Interventional

Funder types

Industry

Identifiers

NCT02125734

2013-004223-37 (EudraCT Number)

CQVA149ADE04

Details and patient eligibility

About

The study is a multicenter, randomized, 2-period, open-label, two arm, cross-over study to show the superior effect of a 4 week treatment each with QVA149 versus tiotropium on lung function. Similarly, this study aims to evaluate patient preference after experiencing both treatment regimens in patients with a clinical diagnosis of COPD (GOLD 2013) and a moderate to severe airflow limitation who are symptomatic (defined as CAT score of at least 10) at screening despite being treated with tiotropium

Enrollment

88 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

signed an Informed Consent Form
stable COPD according to current guidelines (GOLD 2013)
airflow limitation indicated by a post-bronchodilator FEV1/FVC ratio of <0.70 and a post-bronchodilator FEV1 of ≥30% and <80% of predicted normal values at Visit 2.
current or ex-smokers who have a smoking history of at least 10 pack years
Patients on stable tiotropium (18 µg/d) monotherapy for at least 8 weeks before Visit 1
Symptomatic patients defined as patients with CAT score ≥ 10 at Visit 1 (Screening).

Exclusion criteria

Pregnant or breast feeding mothers
Patients with conditions contraindicated for treatment
Patients with a history of clinically significant diseases
Patients who have a clinically significant renal disease
Patients with myocardial infarctions less than 6 months prior to study entry
Patients with recent (less than 1 year) history of NYHA Class III/IV left ventricular failure.
Patients with narrow-angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or urinary retention
Patients with a history of malignancy of any organ system
Patients who have had a COPD exacerbation that required treatment with antibiotics, and/or systemic steroids (oral or intravenous) and/or hospitalization in the 6 weeks prior to Screening
Patients who have had a respiratory tract infection within 6 weeks prior to Screening
Patients with any history of asthma.