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

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)

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

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease; COPD
• Intervention / Treatment: Drug: QVA149; Drug: Tiotropium

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 12203
    • Novartis Investigative Site
  • Berlin, Germany, 13057
    • Novartis Investigative Site
  • Bonn, Germany, 53119
    • Novartis Investigative Site
  • Frankfurt, Germany, 60389
    • Novartis Investigative Site
  • Frankfurt, Germany, 60318
    • Novartis Investigative Site
  • Garmisch-Partenkirchen, Germany, 82467
    • Novartis Investigative Site
  • Hannover, Germany, 30173
    • Novartis Investigative Site
  • Kassel, Germany, 34121
    • Novartis Investigative Site
  • Leipzig, Germany, 04275
    • Novartis Investigative Site
  • München, Germany, 80686
    • Novartis Investigative Site
  • Münster, Germany, 48147
    • Novartis Investigative Site
  • Neu Isenburg, Germany, 63263
    • Novartis Investigative Site
  • Rheine, Germany, 48431
    • Novartis Investigative Site
  • Siegen, Germany, 57072
    • Novartis Investigative Site
  • Solingen, Germany, 42665
    • Novartis Investigative Site
  • Sonneberg, Germany, 96515
    • Novartis Investigative Site
  • Warendorf, Germany, 48231
    • Novartis Investigative Site
  • Rheinland Pfalz
    • Ibbenbüren, Rheinland Pfalz, Germany, 49477
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment sequence 1; QVA149 from day 1 to day 28 and tiotropium from day 29 to day 56	Drug: QVA149; QVA149 capsules 110/50 µg for inhalation via Concep-1-inhaler device, taken once a day; Other Names: indacaterol maleate/glycoporromium bromide; Drug: Tiotropium; Tiotropium 18 µg capsules for inhalation via HandiHaler device taken once a day
Experimental: Treatment sequence 2; Tiotropium from day 1 to day 28 and QVA149 from day 29 to day 56	Drug: QVA149; QVA149 capsules 110/50 µg for inhalation via Concep-1-inhaler device, taken once a day; Other Names: indacaterol maleate/glycoporromium bromide; Drug: Tiotropium; Tiotropium 18 µg capsules for inhalation via HandiHaler device taken once a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: April 1, 2014
• Primary Completion (Actual): January 1, 2015
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: April 24, 2014
• First Submitted That Met QC Criteria: April 25, 2014
• First Posted (Estimate): April 29, 2014

Study Record Updates

• Last Update Posted (Actual): April 12, 2017
• Last Update Submitted That Met QC Criteria: March 14, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Anticonvulsants; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Tiotropium Bromide; Bromides
• Other Study ID Numbers: CQVA149ADE04; 2013-004223-37 (EudraCT Number)