Clinical trial NCT00558285: Safety and Tolerability of QVA149 (Indacaterol/Glycopyrrolate) Compared to Placebo and to Indacaterol in Patients With Moderate to Severe Stable Chronic Obstructive Pulmonary Disease (COPD)
Official title: A Randomized, Double Blind, Placebo Controlled, Multicenter Study to Determine the Effect of QVA149 on Mean 24-hours Heart Rate in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD
Chronic Obstructive Pulmonary Disease
Indacaterol
QVA149
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-11-14
Enrollment: 257
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An investigational inhalation product (QVA149) for the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD) is being developed. This 14 day study will investigate the effect on heart rate and cardiovascular effects to ensure the product is safe.


Eligibility criteria: Inclusion Criteria:

* Consented male or female adults aged ≥40 years
* Moderate to severe stable Chronic Obstructive Pulmonary Disease (COPD) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines (2006)
* Patients who have smoking history of at least 10 pack years
* Patients with a post-bronchodilator Forced Expiratory Volume in one second (FEV1) ≥30% and \<80% of the predicted normal and post-bronchodilator FEV1/Forced vital capacity (FVC) \<0.70 at Visit 1 and Visit 3

Exclusion Criteria:

* Pregnant or nursing (lactating) women
* Patients requiring long term oxygen therapy (\> 15 hours a day) on a daily basis for chronic hypoxemia, or who have been hospitalized or visited an emergency room for a COPD exacerbation in the 6 weeks prior to screening (Visit 1) or during the screening period
* Patients who had a respiratory tract infection within 6 weeks of Visit 1 or at screening
* Concomitant pulmonary disease, pulmonary tuberculosis (TB) (unless chest x-ray confirms no longer active) or clinically significant bronchiectasis
* Any history of asthma
* Patients who have clinically relevant lab abnormalities / conditions such as (but not limited to) long term prednisone therapy, unstable ischemic heart disease, left ventricular failure, history of myocardial infarction, arrhythmia (excluding stable atrial fibrillation \[AF\]), uncontrolled hypertension, narrow-angle glaucoma, symptomatic prostatic hyperplasia or bladder-neck obstruction or moderate to severe renal impairment, uncontrolled hypo- and hyperthyroidism, hypokalemia, hyperadrenergic state or any condition which might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study
* Patients with a history of cardiac failure, life threatening arrhythmias (screening Holter) and acute ischemic changes (screening ECG)
* Patients with a history of long QT syndrome or whose QTc (Fridericia method) interval measured at screening (Visit 1) is prolonged (\>450 ms for males or \>470 for females)
* History of malignancy of any organ system, treated or untreated within the past 5 years
* Uncontrolled Type I / Type II Diabetes or blood glucose outside the normal range or Hemoglobin A1C (HbA1c) \>8.0% of total hemoglobin measured at Visit 1

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Change From Baseline in Mean 24 Hour Heart Rate at Day 14
timeFrame: Baseline, Day 14
Secondary outcomes:
measure: Change From Baseline in Mean 24 Hour Heart Rate at Day 1
timeFrame: Baseline, Day 1
measure: Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 1 and Day 14
timeFrame: Day 1, Day 14
measure: Trough Forced Vital Capacity (FVC) at Day 1 and Day 14
timeFrame: Day 1 and Day 14
measure: Change From Baseline in QTc (Fridericia's Formula) at Day 1
timeFrame: Baseline, Day 1
measure: Change From Baseline in QTc (Fridericia's Formula) at Day 7
timeFrame: Baseline, Day 7
measure: Change From Baseline in QTc (Fridericia's Formula) at Day 14
timeFrame: Baseline, Day 14
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: Novartis Investigator Site
city: Clayton
country: Australia
facility: Novartis Investigator Site
city: Daw Park
country: Australia
facility: Novartis Investigator Site
city: Heidelberg
country: Australia
facility: Novartis Investigator site
city: Nedlands
country: Australia
facility: Novartis Investigator Site
city: Brussels
country: Belgium
facility: Novartis Investigator Site
city: Jambes
country: Belgium
facility: Novartis Investigator Site
city: Jette
country: Belgium
facility: Novartis Investigator Site
city: Liege
country: Belgium
facility: Novartis Investigator site
city: Oostende
country: Belgium
facility: Novartis Investigator Site
city: Mississauga
country: Canada
facility: Novartis Investigator Site
city: Newmarket
country: Canada
facility: Novartis Investigator Site
city: Ottawa
country: Canada
facility: Novartis Investigator Site
city: Pointe-Claire
country: Canada
facility: Novartis Investigator Site
city: Quebec
country: Canada
facility: Novartis Investigator Site
city: Sainte-Foy
country: Canada
facility: Novartis Investigator Site
city: Ambroise
country: France
facility: Novartis Investigator Site
city: Lille
country: France
facility: Novartis Investigator Site
city: Marseille
country: France
facility: Novartis Investigator Site
city: Martigues
country: France
facility: Novartis investigator site
city: Nantes
country: France
facility: Novartis Investigator Site
city: Nice
country: France
facility: Novartis Investigator site
city: Perpignan
country: France
facility: Novartis Investigator Site
city: Berlin
country: Germany
facility: Novartis Investigator Site
city: Dortmund
country: Germany
facility: Novartis Investigator Site
city: Erfurt
country: Germany
facility: Novartis Investigator Site
city: Hannover
country: Germany
facility: Novartis Investigator Site
city: Mainz
country: Germany
facility: Novartis Investigator Site
city: Marburg
country: Germany
facility: Novartis Investigator Site
city: Firenze
country: Italy
facility: Novartis Investigator Site
city: Modena
country: Italy
facility: Novartis Investigator site
city: Trieste
country: Italy
facility: Novartis Investigator Site
city: Badalona
country: Spain
facility: Novartis Investigator Site
city: Baracaldo
country: Spain
facility: Novartis Investigator Site
city: Caceres
country: Spain
facility: Novartis Investigator Site
city: Centelles
country: Spain
facility: Novartis Investigator Site
city: Mataro
country: Spain
facility: Novartis Investigator Site
city: Valencia
country: Spain
facility: Novartis Investigator Site
city: Istanbul
country: Turkey
facility: Novartis Investigator Site
city: Izmir
country: Turkey
facility: Novartis Investigator Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharma AG
role: STUDY_CHAIR
References: