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

Primary Purpose

Chronic Obstructive Pulmonary Disease, COPD

Status
Completed
Phase
Phase 4
Locations
Germany
Study Type
Interventional
Intervention
QVA149
Tiotropium
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Treatment sequence 1

Treatment sequence 2

Arm Description

QVA149 from day 1 to day 28 and tiotropium from day 29 to day 56

Tiotropium from day 1 to day 28 and QVA149 from day 29 to day 56

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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

Full Information

First Posted
April 24, 2014
Last Updated
March 14, 2017
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02125734
Brief Title
Lung Function and Patient Preference With QVA149 vs. Tiotropium in COPD Patients
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
January 2015 (Actual)
Study Completion Date
January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, COPD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment sequence 1
Arm Type
Experimental
Arm Description
QVA149 from day 1 to day 28 and tiotropium from day 29 to day 56
Arm Title
Treatment sequence 2
Arm Type
Experimental
Arm Description
Tiotropium from day 1 to day 28 and QVA149 from day 29 to day 56
Intervention Type
Drug
Intervention Name(s)
QVA149
Other Intervention Name(s)
indacaterol maleate/glycoporromium bromide
Intervention Description
QVA149 capsules 110/50 µg for inhalation via Concep-1-inhaler device, taken once a day
Intervention Type
Drug
Intervention Name(s)
Tiotropium
Intervention Description
Tiotropium 18 µg capsules for inhalation via HandiHaler device taken once a day
Primary Outcome Measure Information:
Title
Forced Expiratory Volume in One Second (FEV1) at 1 h Post-inhalation
Description
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.
Time Frame
week 4
Secondary Outcome Measure Information:
Title
Patient Preference After Experiencing Both Treatments Was Assessed at the End of Treatment Period 2 With a Patient Preference Questionnaire.
Description
Patient preference after experiencing both treatments. The patient's preference questionnaire was a two-choice question (preference for QVA149 OR Tiotropium.
Time Frame
8 weeks
Title
Investigator Preference Per Patient After Experiencing Both Treatments for Future Suggestions.
Description
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
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Ibbenbüren
State/Province
Rheinland Pfalz
ZIP/Postal Code
49477
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
13057
Country
Germany
Facility Name
Novartis Investigative Site
City
Bonn
ZIP/Postal Code
53119
Country
Germany
Facility Name
Novartis Investigative Site
City
Frankfurt
ZIP/Postal Code
60318
Country
Germany
Facility Name
Novartis Investigative Site
City
Frankfurt
ZIP/Postal Code
60389
Country
Germany
Facility Name
Novartis Investigative Site
City
Garmisch-Partenkirchen
ZIP/Postal Code
82467
Country
Germany
Facility Name
Novartis Investigative Site
City
Hannover
ZIP/Postal Code
30173
Country
Germany
Facility Name
Novartis Investigative Site
City
Kassel
ZIP/Postal Code
34121
Country
Germany
Facility Name
Novartis Investigative Site
City
Leipzig
ZIP/Postal Code
04275
Country
Germany
Facility Name
Novartis Investigative Site
City
München
ZIP/Postal Code
80686
Country
Germany
Facility Name
Novartis Investigative Site
City
Münster
ZIP/Postal Code
48147
Country
Germany
Facility Name
Novartis Investigative Site
City
Neu Isenburg
ZIP/Postal Code
63263
Country
Germany
Facility Name
Novartis Investigative Site
City
Rheine
ZIP/Postal Code
48431
Country
Germany
Facility Name
Novartis Investigative Site
City
Siegen
ZIP/Postal Code
57072
Country
Germany
Facility Name
Novartis Investigative Site
City
Solingen
ZIP/Postal Code
42665
Country
Germany
Facility Name
Novartis Investigative Site
City
Sonneberg
ZIP/Postal Code
96515
Country
Germany
Facility Name
Novartis Investigative Site
City
Warendorf
ZIP/Postal Code
48231
Country
Germany

12. IPD Sharing Statement

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

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