Chronic Obstructive Pulmonary Disease (COPD) MedDRA version: 12.1 Level: LLT Classification code 10010952 Term: COPD MedDRA version: 12.1 Level: LLT Classification code 10010953 Term: COPD exacerbation
Conditions
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 pack-years 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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 (NOTE: Reliable contraception should be maintained throughout the study): • 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. 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, systemic steroids (oral or intravenous) 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). Patients with such events not considered clinically significant by the investigator may be considered for inclusion in the study. • 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. (Patients with a transurethral resection of prostate (TURP) are excluded from
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate that QVA149 (110/50 µg o.d.) is superior to NVA237 (50 µg o.d.) with regard to the rate of moderate to severe COPD exacerbations during the treatment period.;Secondary Objective: To demonstrate that QVA149 (110/50 µg o.d.) is superior to open-label tiotropium (18 µg o.d.) with regard to the rate of moderate to severe COPD exacerbations during the treatment period. For other secondary objectives, please consult the protocol ;Primary end point(s): To demonstrate that QVA149 (110/50 µg o.d.) is superior to NVA237 (50 µg o.d.) with regard to the rate of moderate to severe COPD exacerbations during the treatment period | — |
Countries
Austria, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Netherlands, Poland, Spain, United Kingdom
Outcome results
None listed