A 26-week, randomized, double blind, parallel-group multicenter study to assess the efficacy and safety of QVA149 (110/50 mcg o.d.) vs tiotropium (18 mcg o.d.) + salmeterol/fluticasone propionate FDC (50/500 mcg b.i.d.) in patients with moderate to severe COPD
- Conditions
- airflow limitationCOPD10024970
- Registration Number
- NL-OMON43821
- Lead Sponsor
- TFS Trial Form Support BV
- Brief Summary
Trial is onging in other countries
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 28
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 < 80% of the predicted normal value,
and post-bronchodilator FEV1/FVC < 0.70 at run-in Visit 101.
(Post refers to 15 min after inhalation of 400 *g of salbutamol) (Readings assessed by site
and checked centrally).
5. Current or ex-smokers who have a smoking history of at least 10 pack years (e.g. 10 pack
years <= 1 pack /day x 10 years, or * pack/day x 20 years). An ex-smoker is defined as a
patient who has not smoked for * 6 months at screening.
6. Patients who are on triple treatment at least for the last 6 months (LAMA +LABA/ICS).
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Patients who have signed Informed Consent Form prior to<br /><br>initiation of any study-related procedure.<br /><br>* Male and female adults aged * 40 years.<br /><br>* Patients with moderate to severe airflow obstruction with stable<br /><br>COPD according to the 2014 GOLD Guidelines.<br /><br>* Patients with a post-bronchodilator FEV1 *40 and < 80% of the<br /><br>predicted normal value, and post-bronchodilator FEV1/FVC <<br /><br>0.70 at run-in Visit 101.<br /><br>(Post refers to 15 min after inhalation of 400 *g of salbutamol).<br /><br>* Current or ex-smokers who have a smoking history of at least 10<br /><br>pack years (e.g. 10 pack years = 1 pack /day x 10 years, or *<br /><br>pack/day x 20 years). An ex-smoker is defined as a patient who<br /><br>has not smoked for * 6 months at screening.<br /><br>* Patients who are on triple treatment at least for the last 6 months<br /><br>(LAMA +LABA/ICS).</p><br>
- Secondary Outcome Measures
Name Time Method