A multi-centre randomized double blind 12-week study to assess the efficacy, safety and tolerability of QVA149 in patients with COPD who have moderate to severe airflow limitatio

• Conditions: Chronic Obstructive Pulmonary Disease (COPD); MedDRA version: 16.1Level: LLTClassification code 10010952Term: COPDSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2012-003347-30-SK
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08-14
• Last Update Posted: 23 February 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

1. Patients who have signed an Informed Consent Form prior to initiation
of any studyrelated procedure.
2. Male and female adults aged =40 years.
3. Patients with stable COPD according to the current GOLD strategy.
4. Patients with airflow limitation indicated by a post-bronchodilator
FEV1 = 30% and <80% of the predicted normal, and a postbronchodilator
FEV1/FVC < 0.70 at run-in (Visit 101). Post
bronchodilator refers to 1 hour after sequential inhalation of 84 µg
ipratropium bromide (or equivalent dose) and 400 µg salbutamol (or 360
µg albuterol). Spacer devices are not permitted during reversibility
testing.
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 ½ pack/day x 20
years). An ex-smoker may be defined as a subject who has not smoked
for = 6 months at screening.
6. Patients with an mMRC grade 2 or greater at Visit 101.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 520
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 480

Exclusion Criteria

1. Pregnant or nursing (lactating) women, where pregnancy is defined
as the state of a female after conception and until the termination of
gestation, confirmed by a positive hCG (human Chorionic Gonadotropin)
laboratory test.
2. Women of child-bearing potential, defined as all women
physiologically capable of becoming pregnant, unless they are using
effective methods of contraception during dosing of study treatment.
Effective contraception methods are described in the protocol.
3. Patients with Type I or uncontrolled Type II diabetes.
4. Patients with a history of long QT syndrome or whose QTc measured
at Visit 101 (Fridericia method) is prolonged (>450 ms for males and
females) and confirmed by a central assessor. These patients should not
be re-screened.
5. Patients who have a clinically significant ECG abnormality at Visit 101
or Visit 102. (These patients should not be re-screened)
6. Patients who have a clinically significant laboratory abnormality at
Visit 101.
7. Patients with a body mass index (BMI) of more than 40 kg/m2.
8. 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.
9. 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., selective 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 the atrial fibrillation must be
confirmed by central reading.
10. 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:
• anticholinergic agents
• long and short acting beta-2 agonists
• sympathomimetic amines
• lactose or any of the other excipients of trial medication
For a full list of esclusion criteria, please refer to the protocol

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified