chronic obstructive pulmonary disease (COPD) MedDRA version: 14.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Sponsors
Novartis Pharma GmbH
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 moderate to severe stable COPD (Stage II or Stage III) according to the GOLD Guidelines 2010. 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 etc.) 4. Patients with a post-bronchodilator FEV1 =30% and =65 years) yes F.1.3.1 Number of subjects for this age range 550
Exclusion criteria
Exclusion criteria: 1. Women who are pregnant or breast feeding 2. Women of child-bearing potential must use effective contraception 3. Patients with conditions 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 • anticholinergics • long and short acting beta-2 agonists • sympathomimetic amines • lactose or any of the other excipients 4. Patients with a history of long QT syndrome or whose QTc measured at Visit 2 is prolonged (>450 ms for males and females). 5. Patients who have a clinically significant abnormality on the ECG at Visit 2, who in the judgment of the investigator would be at potential risk if enrolled into the study. (These patients should not be re-screened). 6. Patients with paroxysmal (e.g. intermittent) atrial fibrillation are excluded. 7. Patients with Type I or uncontrolled Type II diabetes including patients with a history of blood glucose levels consistently outside the normal range or HbA1c> 8.0% of a total Hb measured at screening (Visit 2). 8. Patients with 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 the study. Patients who have undergone full re-section of the prostate may be considered for the study, as well as patients who are asymptomatic and stable on pharmacological treatment for the condition). 9. Patients with a 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. Patients with non-melanoma skin carcinoma may be considered for the study. 10. 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 (NYHA Class III & IV), 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. • uncontrolled hypo-or hyperthyroidism, hypokalemia or hyperadrenergic state • any condition which might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study 11. Patients who are, in the opinion of the investigator known to be unreliable or non-compliant. 12. Patients with a body mass index (BMI) of more than 40 kg/m2. COPD specific exclusion 13. Patients requiring long term oxygen therapy (> 15 h a day) on a daily basis for chronic hypoxemia. 14. 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 pre-screening. 15. Patients who develop a COPD exacerbation between the pre-screening and the randomization visit 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. 16. Patients who have had a respiratory tract infection within 6 weeks prior to pre-screening (Visit 1). 17. Patients who develop a respiratory tract infection between pre-screening and randomization (up to Visit 3)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate non-inferiority of QVA149 110/50 µg to tiotropium 18 µg q.d. plus formoterol 12µg b.i.d. in terms of health related quality of life as assessed by St George’s Respiratory Questionnaire (SGRQ-C) after 26 weeks of treatment in moderate to severe COPD patients. ;Secondary Objective: To evaluate QVA149 110/50 µg q.d. as compared to tiotropium 18 µg q.d. plus formoterol 12µg b.i.d. following 26 weeks of treatment in terms of improvement of dyspnea as assessed by BDI/TDI. To evaluate QVA149 110/50 µg q.d. as compared to tiotropium plus formoterol during 26 weeks of treatment in terms of • Rate of moderate/severe COPD exacerbations requiring systemic corticosteroids and/or antibiotics or hospitalization • Time to first moderate/severe COPD exacerbation during the treatment period • Lung function assessed by trough FEV1 • Lung function assessed by FEV1 30 min • Symptoms reported by the patients using component score of Part I “Symptoms” of the St George’s Respiratory Questionnaire (SGRQ-C). ;Primary end point(s): The primary efficacy variable, is the change from baseline of quality of life as assessed St George’s Respiratory Questionnaire (SGRQ-C) at the end of the study.;Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): All continuous secondary endpoints BDI/TDI, CAT, Part I “Symptoms” of the St George’s Respiratory Questionnaire (SGRQ-C) and FEV1 (pre- and post-dose measurements) will be analyzed analogous to the primary endpoint (i.e. ANCOVA models with factors treatment, center and baseline). Rates of exacerbations will be displayed descriptively (# (%) of Pts with- # of exacerbations), the same display will be used for patients requiring corticosteroids/antibiotics. Time to exacerbation will be displayed using Kaplan-Meier plots.;Timepoint(s) of evaluation of this end point: 6 months | — |
Countries
Germany
Contacts
Public ContactMedizinischer Infoservice
Novartis Pharma GmbH
Outcome results
None listed