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)

• Register: ClinicalTrials.gov
• Last refreshed on: 3 December 2012
• Main ID: NCT00558285
• Date of registration: 12/11/2007
• Primary sponsor: Novartis
• Public title: 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)
• Scientific 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)
• Date of first enrolment: November 2007
• Target sample size: 257
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00558285
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Countries of recruitment

Australia, Belgium, Canada, France, Germany, Italy, Spain, Turkey

Contacts

• Name: Novartis Pharma AG
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion 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confirms no longer active) or clinically significant bronchiectasis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



Age minimum: 40 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Obstructive Pulmonary Disease (COPD)

Intervention(s)

Drug: glycopyrrolate

Drug: indacaterol

Drug: indacaterol/glycopyrrolate

Drug: placebo

Primary Outcome(s)

Change From Baseline in Mean 24 Hour Heart Rate at Day 14 [Time Frame: Baseline, Day 14]

Secondary Outcome(s)

Change From Baseline in Mean 24 Hour Heart Rate at Day 1 [Time Frame: Baseline, Day 1]

Change From Baseline in QTc (Fridericia's Formula) at Day 1 [Time Frame: Baseline, Day 1]

Change From Baseline in QTc (Fridericia's Formula) at Day 14 [Time Frame: Baseline, Day 14]

Change From Baseline in QTc (Fridericia's Formula) at Day 7 [Time Frame: Baseline, Day 7]

Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 1 and Day 14 [Time Frame: Day 1, Day 14]

Trough Forced Vital Capacity (FVC) at Day 1 and Day 14 [Time Frame: Day 1 and Day 14]

Secondary ID(s)

CQVA149A2203

Source(s) of Monetary Support

Please refer to primary and secondary sponsors