Clinical trial NCT02125734: Lung Function and Patient Preference With QVA149 vs. Tiotropium in COPD Patients
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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease
COPD
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2014-04-29
Enrollment: 88
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Forced Expiratory Volume in One Second (FEV1) at 1 h Post-inhalation
timeFrame: week 4
Secondary outcomes:
measure: Patient Preference After Experiencing Both Treatments Was Assessed at the End of Treatment Period 2 With a Patient Preference Questionnaire.
timeFrame: 8 weeks
measure: Investigator Preference Per Patient After Experiencing Both Treatments for Future Suggestions.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Ibbenbüren
country: Germany
facility: Novartis Investigative Site
state: Rheinland Pfalz
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Bonn
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Garmisch-Partenkirchen
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Kassel
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: München
country: Germany
facility: Novartis Investigative Site
city: Münster
country: Germany
facility: Novartis Investigative Site
city: Neu Isenburg
country: Germany
facility: Novartis Investigative Site
city: Rheine
country: Germany
facility: Novartis Investigative Site
city: Siegen
country: Germany
facility: Novartis Investigative Site
city: Solingen
country: Germany
facility: Novartis Investigative Site
city: Sonneberg
country: Germany
facility: Novartis Investigative Site
city: Warendorf
country: Germany
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: