Study of efficacy and safety of QVA149 compared to standard of care, a combination of fluticasone/salmeterol, in patients with moderate to severe COPD

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 554

Inclusion Criteria

- Patients who have signed an Informed Consent Form prior to initiation of any study-related procedure
- Male and female adults aged =40 years
- Patients with stable COPD according to the current GOLD strategy (GOLD 2011)
- Patients with airflow limitation indicated by a post-bronchodilator FEV1 = 30% and < 80% of the predicted normal, and a post-bronchodilator
FEV1/FVC < 0.7 at run-in (Visit 101)
- 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
- 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 288
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 266

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 laboratory. 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.

For more exclusion criteria, please refer to the protocol.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials