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Completed

NCT Number: NCT02125734

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

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

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Key information

Conditions

Chronic Obstructive Pulmonary Disease COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site, Ibbenbüren, Rhineland-Palatinate, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

QVA149

Drug

QVA149 capsules 110/50 µg for inhalation via Concep-1-inhaler device, taken once a day

Other names: indacaterol maleate/glycoporromium bromide

Tiotropium

Drug

Tiotropium 18 µg capsules for inhalation via HandiHaler device taken once a day

Primary outcomes

  1. Forced Expiratory Volume in One Second (FEV1) at 1 h Post-inhalation

    Time frame: week 4

    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 outcomes

  1. Patient Preference After Experiencing Both Treatments Was Assessed at the End of Treatment Period 2 With a Patient Preference Questionnaire.

    Time frame: 8 weeks

    Patient preference after experiencing both treatments. The patient's preference questionnaire was a two-choice question (preference for QVA149 OR Tiotropium.

  2. Investigator Preference Per Patient After Experiencing Both Treatments for Future Suggestions.

    Time frame: 8 weeks

    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

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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)

Acronym: FAVOR

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 29, 2014
Registry last updated
Apr 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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