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

Chronic Obstructive Pulmonary Disease Clinical Trial

— FAVOR  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02125734
• Other study ID #: CQVA149ADE04
• Secondary ID: 2013-004223-37
• Status: Completed
• Phase: Phase 4
• First received: April 24, 2014
• Last updated: December 14, 2015
• Start date: April 2014
• Est. completion date: January 2015

Study information

• Verified date: December 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Bundesamt für Arzneimittel und Medizinprodukte
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• COPD
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• QVA149
QVA149 capsules 110/50 µg for inhalation via Concep-1-inhaler device, taken once a day
• Tiotropium
Tiotropium 18 µg capsules for inhalation via HandiHaler device taken once a day

Locations

Country	Name	City	State
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	Hannover
Germany	Novartis Investigative Site	Ibbenbüren	Rheinland Pfalz
Germany	Novartis Investigative Site	Kassel
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	München
Germany	Novartis Investigative Site	Münster
Germany	Novartis Investigative Site	Neu Isenburg
Germany	Novartis Investigative Site	Rheine
Germany	Novartis Investigative Site	Siegen
Germany	Novartis Investigative Site	Solingen
Germany	Novartis Investigative Site	Sonneberg
Germany	Novartis Investigative Site	Warendorf

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Forced Expiratory Volume in One Second (FEV1) at 1 h Post-inhalation	Forced Expiratory Volume in one second (FEV1) will be calculated as the volume of air forcibly exhaled in one second as measured by a spirometer.	week 4	No
Secondary	Patient Preference After Experiencing Both Treatments Was Assessed at the End of Treatment Period 2 With a Patient Preference Questionnaire.	Patient preference after experiencing both treatments. The patient's preference questionnaire was a two-choice question (preference for QVA149 OR Tiotropium.	8 weeks	No
Secondary	Investigator Preference Per Patient After Experiencing Both Treatments for Future Suggestions.	The investigator preference for future treatment suggestion after experiencing both treatments was assessed at the end of treatment period 2 with the Investigator Preference Questionnaire	8 weeks	No