A Study to Assess the Long-term Safety of QVA149

Phase 3

Completed

Conditions: Chronic Obstructive Pulmonary Disease

Interventions: Drug: QVA149
Drug: Placebo

Registration Number: NCT01120717

Lead Sponsor: Novartis Pharmaceuticals

Brief Summary: The study is designed to provide long-term safety data for QVA149 in patients with moderate to severe chronic obstructive pulmonary disease (COPD).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 339

Inclusion Criteria

Male or female adults aged ≥40 yrs
Smoking history of at least 10 pack years
Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2008)
Post-bronchodilator FEV1 < 80% and ≥ 30% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) <70%

Exclusion Criteria

Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1
Patients with concomitant pulmonary disease
Patients with a history of asthma
Any patient with lung cancer or a history of lung cancer
Patients with a history of certain cardiovascular co-morbid conditions
Patients with a known history and diagnosis of alpha-1 antitrypsin deficiency
Patients in the active phase of a supervised pulmonary rehabilitation program
Patients contraindicated for inhaled anticholinergic agents and β2 agonists
Other protocol-defined inclusion/exclusion criteria may apply

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
QVA149	QVA149	110µg/50µg capsule for oral inhalation, once daily, delivered by a single dose dry powder inhaler (SDDPI)
Placebo	Placebo	Placebo to match QVA149, capsules for inhalation once daily, delivered by an SDDPI

Primary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events, Serious Adverse Events or Death	52 weeks + Follow-up (Up to Day 394)	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.

Secondary Outcome Measures

Name	Time	Method
Pre-dose FEV1	52 weeks	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.
Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period	52 weeks	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
Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Timepoint Over the Whole Treatment Period	52 weeks	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
Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Timepoint Over the Whole Treatment Period	52 weeks	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.
Number of Patients With Notable Change From Baseline in Fridericia's QTc Values at Any Timepoint Over the Whole Treatment Period	52 weeks	Clinically notable change from baseline was and increase from baseline of 30 or greater milliseconds (ms).