A 52-week treatment, multi-center, randomized, double-blind,parallel-group, active controlled study to evaluate the effect ofQVA149 (110/50 µg o.d.) vs NVA237 (50 µg o.d.) and open-labeltiotropium (18 µg o.d.) on COPD exacerbations in patients withsevere to very severe chronic obstructive pulmonary disease(COPD)
- Conditions
- Chronic Obstructive Pulmonary Disease (COPD)MedDRA version: 12.1Level: LLTClassification code 10010952Term: COPDMedDRA version: 12.1Level: LLTClassification code 10010953Term: COPD exacerbation
- Registration Number
- EUCTR2009-013256-69-NL
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 2200
1. Male or female adults aged =40 years, who have signed an Informed Consent Form prior
to initiation of any study-related procedure.
2. Patients with severe to very severe COPD (Stage III or IV) according to the (GOLD
Guidelines, 2008).
3. 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).
4. Patients with a post-bronchodilator FEV1 < 50% of the predicted normal value, and postbronchodilator
FEV1/FVC < 0.70 at Visit 2 (day -14).
(Post refers to 1 h after sequential inhalation of 84 µg (or equivalent dose) of ipratropium
bromide and 400 µg of salbutamol).
5. A documented history of at least 1 COPD exacerbation in the previous 12 months that
required treatment with systemic glucocorticosteroids and/or antibiotics.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Pregnant women or nursing mothers (pregnancy confirmed by positive urine pregnancy
test).
2. Women of child-bearing potential (WOCBP), defined as all women physiologically
capable of becoming pregnant, including women whose career, lifestyle, or sexual
orientation precludes intercourse with a male partner and women whose partners have
been sterilized by vasectomy or other means, UNLESS they meet the following definition
of post-menopausal: 12 months of natural (spontaneous) amenorrhea, OR 6 weeks after
surgical bilateral oophorectomy (with or without hysterectomy) OR are using one or more
of the following acceptable methods of contraception:
• surgical sterilization (e.g. bilateral tubal ligation)
• hormonal contraception (implantable, patch, oral, IM), and copper coated IUD (if
accepted by local regulatory authority and ethics committee)
• double barrier method (diaphragm plus condom)
• At the discretion of the investigator, total abstinence is acceptable in cases where the
age, career, lifestyle, or sexual orientation of the patient ensures compliance
• Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation
methods) and withdrawal are not acceptable methods of contraception. NOTE:
Reliable contraception should be maintained throughout the study.
3. Patients requiring long term oxygen therapy (> 15 h a day) on a daily basis for chronic
hypoxemia.
4. Patients who have had a COPD exacerbation that required treatment with antibiotics, oral
steroids or hospitalization in the 6 weeks prior to Visit 1 or between Visit 1 (Day -21) and
Visit 3 (Day 1).
5. Patients who develop a COPD exacerbation during a period between Visit 1 and 3 will not
be eligible but will be permitted to be re-screened after a minimum of 6 weeks after the
resolution of the COPD exacerbation.
6. Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1 (Day -
21)
• Patients who develop an upper or lower respiratory tract infection during the
screening period (up to Visit 3 (Day 1) will not be eligible, but will be permitted to be
re-screened 4 weeks after the resolution of the respiratory tract infection
7. Patients with concomitant pulmonary disease, e.g. pulmonary tuberculosis (unless
confirmed by chest x-ray to be no longer active), clinically significant bronchiectasis,
sarcoidosis, interstitial lung disorder or pulmonary hypertension.
8. Patients with lung lobectomy, or lung volume reduction or lung transplantation.
9. Patients who, in the judgment of the investigator, have a clinically relevant laboratory
abnormality or a clinically significant condition such as (but not limited to):
• unstable ischemic heart disease, left ventricular failure, history of myocardial
infarction, arrhythmia (excluding chronic stable AF)
• history of malignancy of any organ system (including lung cancer), treated or
untreated, within the past 5 years whether or not there is evidence of local recurrence
or metastases, with the exception of localized basal cell carcinoma of the skin
• uncontrolled hypo- or hyperthyroidism, hypokalemia or hyperadrenergic state
• narrow-angle glaucoma
• symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe
renal impairment or urinary retention
• any condition which might compromise patient safety or compliance, interfere with
evaluation, or preclude completion of the study
10. Patients with any history of asthma indicated by (but not limited to) a blood eosinophil
count > 60
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate that QVA149 (110/50 µg o.d.) is superior to NVA237 (50 µg o.d.) with<br>regard to the rate of moderate to severe COPD exacerbations during 52 weeks of treatment.;Secondary Objective: 2.2 Key secondary objective<br>• To demonstrate that QVA149 (110/50 µg o.d.) is superior to open-label tiotropium (18 µg<br>o.d.) with regard to the rate of moderate to severe COPD exacerbations during 52 weeks<br>of treatment<br>Other secondary objectives<br>• To demonstrate that QVA149 (110/50 µg o.d.) is superior to NVA237 (50 µg o.d.) with<br>regard to the time to first moderate to severe COPD exacerbation during 52 weeks of<br>treatment<br>• To demonstrate that QVA149 (110/50 µg o.d.) is superior to open-label tiotropium (18 µg<br>o.d.) with regard to the time to first moderate to severe COPD exacerbation during 52<br>weeks of treatment;Primary end point(s): the rate of moderate to severe COPD exacerbations during 52 weeks of treatment
- Secondary Outcome Measures
Name Time Method