airflow limitation COPD
Conditions
Interventions
QVA149 110/50 *g capsules o.d. for inhalation, supplied in blisters
delivered via Novartis single dose dry powder inhaler Novartis single
dose dry powder inhalerNovartis single dose dry powder inhaler
Sponsors
TFS Trial Form Support BV
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients eligible for inclusion in this study have to fulfill all of the following criteria: 1. Patients who have signed Informed Consent Form prior to initiation of any study-related procedure. 2. Male and female adults aged * 40 years. 3. Patients with moderate to severe airflow obstruction with stable COPD (Stage 2 or Stage 3) according to the 2014 GOLD Guidelines. 4. Patients with a post-bronchodilator FEV1 *40 and
Exclusion criteria
Exclusion criteria: Patients fulfilling any of the following criteria are not eligible for inclusion in this study. No additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible patients. 1. Use of other investigational drugs/devices (approved or unapproved) at the time of enrollment, or within 30 days or 5 half-lives of Visit 1, whichever is longer. 2. Patients contraindicated for treatment with, or having a history of reactions/ hypersensitivity to any of the following inhaled drugs, drugs of a similar class or any component thereof: * long and short anticholinergic agents * long and short acting beta-2 agonists * sympathomimetic amines * lactose or any of the other excipients of trial medication 3. History or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study such as: * Concomitant clinically significant cardiac arrhythmias, e.g., sustained ventricular tachycardia, and clinically significant second or third degree AV block without a pacemaker * History of familial long QT syndrome or known family history of Torsades de Pointes 4. Resting QTc (Fridericia method) *450 msec for males and females at Visit 101. 5. Concomitant use of agents known to significantly prolong the QT interval unless it can be permanently discontinued for the duration of study. 6. Patients who have a clinically significant laboratory abnormality at Visit 101 and would be at potential risk if enrolled into the study. 7. Patients who have clinically significant renal, cardiovascular (such as but not limited to unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, myocardial infarction), arrhythmia (see below for patients with atrial fibrillation), neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities which could interfere with the assessment of the efficacy and safety of the study treatment. 8. Patients with paroxysmal (e.g. intermittent) atrial fibrillation are excluded. Patients with persistent atrial fibrillation as defined by continuous atrial fibrillation for at least 6 months and controlled with a rate control strategy (i.e., beta blocker, calcium channel blocker, pacemaker placement, digoxin or ablation therapy) for at least 6 months may be considered for inclusion. In such patients, atrial fibrillation must be present at Visit 101 and Visit 102) visits, with a resting ventricular rate < 100/min. At visit 101, atrial fibrillation must be confirmed by central reading. 9. Patients with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment or urinary retention (BPH patients who are stable on treatment can be considered). 10. Patients who have not achieved acceptable spirometry results at Visit 101 in accordance with ATS (American Thoracic Society)/ERS (European Respiratory Society) criteria for acceptability (one retest may be performed for patients that don*t meet the acceptability criteria). 11. Patients who have had more than one COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the last year prior to Visit 1. 12. Patients who developed
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patients who have signed Informed Consent Form prior to initiation of any study-related procedure. * Male and female adults aged * 40 years. * Patients with moderate to severe airflow obstruction with stable COPD according to the 2014 GOLD Guidelines. * Patients with a post-bronchodilator FEV1 *40 and | — |
Secondary
| Measure | Time frame |
|---|---|
| * Key exclusion criteria. Full criteria are within the protocol: * Patients contraindicated for treatment with, or having a history of reactions/ hypersensitivity to any of the following inhaled drugs, drugs of a similar class or any component thereof: * long and short acting anticholinergic agents * long and short acting beta-2 agonists * sympathomimetic amines * lactose or any of the other excipients of trial medication * History or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study such as: * Concomitant clinically significant cardiac arrhythmias, e.g., sustained ventricular tachycardia, and clinically significant second or third degree AV block without a pacemaker * History of familial long QT syndrome or known family history of Torsades de Pointes * Resting QTc (Fridericia method) *450 msec for males and females at Visit 101. * Concomitant use of agents known to significantly prolong the QT interval unless they can be permanently discontinued for the duration of study. * Patients who have clinically significant renal, cardiovascular (such as but not limited to unstable ischemic heart disease, NYHA Class III/IV left ventricular failure, myocardial infarction), arrhythmia (see below for patients with atrial fibrillation), neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological abnormalities which could interfere with the assessment of the efficacy and safety of the study treatment. * Patients who have had more than one COPD exacerbation that required treatment with antibiotics and/or oral corticosteroids and/or hospitalization in the 12 months prior to Visit 1. * Patients who developed a COPD exacerbation of any severity either 6 weeks before the screening (Visit 1) or between screening (Visit 1) and treatment (Visit 201) will not be eligible but will be permitted to be re-screened after a minimum of 6 weeks after the reso | — |
Countries
Netherlands
Outcome results
None listed