Phase 4
N=88
Lung Function and Patient Preference With QVA149 vs. Tiotropium in COPD Patients
Chronic Obstructive Pulmonary Disease · COPD
Bottom Line
View on ClinicalTrials.gov: NCT02125734 ↗Enrolled (actual)
88
Serious AEs
0.6%
Results posted
Jan 2016
Primary outcome: Primary: Forced Expiratory Volume in One Second (FEV1) at 1 h Post-inhalation — 1.676; 1.595 Liters — p=0.0017
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- QVA149 (Drug); Tiotropium (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Forced Expiratory Volume in One Second (FEV1) at 1 h Post-inhalation |
1.676; 1.595 | 0.0017 sig |
| SECONDARY Patient Preference After Experiencing Both Treatments Was Assessed at the End of Treatment Period 2 With a Patient Preference Questionnaire. |
59; 26 | — |
| SECONDARY Investigator Preference Per Patient After Experiencing Both Treatments for Future Suggestions. |
71; 16 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02125734). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.