Study of efficacy and safety of QVA149 compared to salmeterol/fluticasone active comparator in patients with COPD.

• Conditions: subjects with moderate to very severe COPD; MedDRA version: 14.1Level: LLTClassification code 10010953Term: COPD exacerbationSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2012-004966-16-LV
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-02
• Last Update Posted: 12 October 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 3332

Inclusion Criteria

1. Written informed consent must be obtained before any assessment is performed.
2. Male or female adults aged =40 years.
3. Patients with stable COPD according to the current GOLD strategy (GOLD 2011).
4. Current or ex-smokers who have a smoking history of at least 10 pack years. (Ten packyears
are defined as 20 cigarettes a day for 10 years, or 10 cigarettes a day for 20 years).
5. Patients with a post-bronchodilator FEV1 =25 and < 60% of the predicted normal value,
and post-bronchodilator FEV1/FVC < 0.70 at Visit 101 (day -28).
(Post refers to 1 h after sequential inhalation of 84 µg (or equivalent dose) of ipratropium
bromide and 400 µg of salbutamol).
6. A documented history of at least 1 COPD exacerbation in the previous 12 months that
required treatment with systemic glucocorticosteroids and/or antibiotics.
7. Patients taking stable COPD medication (at least 60 days) prior to Visit 101.
8. Patients with an mMRC grade of at least 2 at Visit 101 (day -28).
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 1800
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 1532

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 include:
• Total abstinence when this is in line with the preferred and usual lifestyle of the
subject (periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation
methods) and withdrawal are not acceptable methods of contraception).
• Female sterilization defined as surgical hysterectomy, bilateral oophorectomy, or
tubal ligation at least six weeks before taking the study treatment (Single
oophorectomy does not meet the definition of female sterilization).
• Male sterilization (at least 6 months prior to screening). For female subjects on the
study, the vasectomized male partner should be the sole partner for that subject.
• Barrier methods of contraception: condom or occlusive cap (diaphragm or
cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository.
• Use of oral, injected or implanted hormonal methods of contraception or other forms
of hormonal contraception that have comparable efficacy (failure rate <1%), for
example hormone vaginal ring or transdermal hormone contraception. In case of use
of oral contraception women should have been stable on the same pill for a minimum
of 3 months before taking study treatment.
• Placement of an intrauterine device (IUD) or intrauterine system (IUS).
Women are considered post-menopausal and not of child bearing potential if they have
had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical
profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical
bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six
weeks ago. In the case of oophorectomy alone, only when the reproductive status of
the woman has been confirmed by follow up hormone level assessment is she
considered not of child bearing potential.
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 201.
(These patients should not be re-screened)
6. Patients who have a clinically significant laboratory abnormality at Visit 101.
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., selective bet

Study & Design

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