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COMPLETEDPHASE4

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

A Randomized, Multicenter, Open-label, Cross-over Study to Assess Lung Function and Patient Preference After a 4 Week Treatment Each With QVA149 vs. Tiotropium in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD) and Moderate to Severe Airflow Limitation Who Are on a Tiotropium Therapy (FAVOR Study)

NCT02125734•Novartis Pharmaceuticals

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

40 - No limit years

Sex

ALL

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
+1 more criteria

Locations (18)

Novartis Investigative Site

Ibbenbüren, Rhineland-Palatinate, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Berlin, Germany

Novartis Investigative Site

Bonn, Germany

Novartis Investigative Site

Frankfurt, Germany

Novartis Investigative Site

Frankfurt, Germany

Novartis Investigative Site

Garmisch-Partenkirchen, Germany

Novartis Investigative Site

Hanover, Germany

Novartis Investigative Site

Kassel, Germany

Novartis Investigative Site

Leipzig, Germany

Key Dates

Start Date

April 1, 2014

Primary Completion Date

January 1, 2015

Completion Date

January 1, 2015

Last Updated

April 12, 2017

Enrollment

ACTUAL participants

Conditions

Chronic Obstructive Pulmonary DiseaseCOPD

Interventions

QVA149

DRUG

Tiotropium

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 12, 2017Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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Effect of Telenursing on Oral Health

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Emotional-distress-based Integrated Care Programme in Patients With an Acute Exacerbation of COPD

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