The study is designed to provide long-term safety data for QVA149 in patients with moderate to severe chronic obstructive pulmonary disease (COPD).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
339
Number of Participants With Adverse Events, Serious Adverse Events or Death
Adverse events are defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal lab finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events are any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgments of the investigators represent significant hazards.
Time frame: 52 weeks + Follow-up (Up to Day 394)
Pre-dose FEV1
Pre-dose FEV1 is defined as the average of the FEV1 15 minutes pre-dose and FEV1 45 minutes pre-dose. A mixed model was used with treatment as a fixed effect, average of 15 min and 45 min pre-dose FEV1 at visit 3 as the baseline measurement, and FEV1 prior to inhalation and FEV1 60 min post inhalation of two short acting bronchodialators as covariates. The model also included smoking status at baseline, history of ICS use and country as fixed effects with center nested within country as a random effect.
Time frame: 52 weeks
Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period
Clinically notable hematology values were: hemoglobin - male \<115g/L, female \<95 g/L; hematocrit - male \<0.37v/v, female \<0.32v/v; white cell count - \<2.8 10E9/L or \>16.0 10E9/L; platelets - \<75 10E9/L or \>700 10E9/L
Time frame: 52 weeks
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period
Clinically notable biochemistry values were: sodium \<125mmol/L or \>160mmol/L; potassium \<3.0mmol/L or \>6.0mmol/L; BUN \>9.99mmol/L; creatinine \>176.8µmol/L; total protein (serum) \<40g/L or \>95g/L; albumin \<25g/L; bilirubin (total) \>34.2µmol/L; SGPT \>3 x ULN; SGOT \> 3 x ULN; gamma glutamyltransferase \>3 x ULN; alkaline phosphatase (serum) \>3 x ULN; glucose \<2.78mmol/L or \>9.99mmol/L
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Novartis Investigative Site
Toronto, Ontario, Canada
Novartis Investigative Site
Mirabel, Quebec, Canada
Novartis Investigative Site
Québec, Quebec, Canada
Novartis Investigative Site
Québec, Quebec, Canada
Novartis Investigative Site
Beuvry, France, France
Novartis Investigative Site
Ferolles-Attily, France, France
Novartis Investigative Site
Montpellier, France
Novartis Investigative Site
Nantes, France
Novartis Investigative Site
Pessac, France
Novartis Investigative Site
Aszód, Hungary
...and 43 more locations
Time frame: 52 weeks
Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Timepoint Over the Whole Treatment Period
Clinically notable vital sign values were: pulse rate - low, \<40 bpm or \<=50 bpm and decrease from baseline \>=15bpm; pulse rate high, \>130 bpm or \>=120bpm and increase from baseline \>=15 bpm. Systolic blood pressure - low, \<75 mmHg or \<=90 mmHg and decrease from baseline \>=20 mmHg; high, \>200 mmHg or \>=180 mmHg and increase from baseline \>=20 mmHg. Diastolic blood pressure - low, \<40 mmHg or \<=50 mmHg and decrease from baseline \>=15 mmHg; high, \>115 mmHg or \>=105 mmHg and increase from baseline \>=15 mmHg.
Time frame: 52 weeks
Number of Patients With Notable Change From Baseline in Fridericia's QTc Values at Any Timepoint Over the Whole Treatment Period
Clinically notable change from baseline was and increase from baseline of 30 or greater milliseconds (ms).
Time frame: 52 weeks