- ICH GCP
- US Clinical Trials Registry
- 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)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Adelaide, Australia
- Novartis Investigator Site
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Clayton, Australia
- Novartis Investigator Site
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Daw Park, Australia
- Novartis Investigator Site
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Heidelberg, Australia
- Novartis Investigator Site
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Nedlands, Australia
- Novartis Investigator Site
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Brussels, Belgium
- Novartis Investigator Site
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Jambes, Belgium
- Novartis Investigator Site
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Jette, Belgium
- Novartis Investigator Site
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Liege, Belgium
- Novartis Investigator Site
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Oostende, Belgium
- Novartis Investigator Site
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Mississauga, Canada
- Novartis Investigator Site
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Newmarket, Canada
- Novartis Investigator Site
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Ottawa, Canada
- Novartis Investigator Site
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Pointe-Claire, Canada
- Novartis Investigator Site
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Quebec, Canada
- Novartis Investigator Site
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Sainte-Foy, Canada
- Novartis Investigator Site
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Ambroise, France
- Novartis Investigator Site
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Lille, France
- Novartis Investigator Site
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Marseille, France
- Novartis Investigator Site
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Martigues, France
- Novartis Investigator Site
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Nantes, France
- Novartis Investigator Site
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Nice, France
- Novartis Investigator Site
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Perpignan, France
- Novartis Investigator Site
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Berlin, Germany
- Novartis Investigator Site
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Dortmund, Germany
- Novartis Investigator Site
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Erfurt, Germany
- Novartis Investigator Site
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Hannover, Germany
- Novartis Investigator Site
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Mainz, Germany
- Novartis Investigator Site
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Marburg, Germany
- Novartis Investigator Site
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Firenze, Italy
- Novartis Investigator Site
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Modena, Italy
- Novartis Investigator Site
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Trieste, Italy
- Novartis Investigator Site
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Badalona, Spain
- Novartis Investigator Site
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Baracaldo, Spain
- Novartis Investigator Site
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Caceres, Spain
- Novartis Investigator Site
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Centelles, Spain
- Novartis Investigator Site
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Mataro, Spain
- Novartis Investigator Site
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Valencia, Spain
- Novartis Investigator Site
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Istanbul, Turkey
- Novartis Investigator Site
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Izmir, Turkey
- Novartis Investigator Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: indacaterol/glycopyrrolate 600/100 μg
Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study. |
Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.
Other Names:
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EXPERIMENTAL: indacaterol/glycopyrrolate 300/100 μg
One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study. |
Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.
Other Names:
Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.
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EXPERIMENTAL: indacaterol/glycopyrrolate 150/100 μg
One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study. |
Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.
Other Names:
Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.
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ACTIVE_COMPARATOR: indacaterol 300 μg
One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study. |
Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.
Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.
Other Names:
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PLACEBO_COMPARATOR: placebo
Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days. The use of salbutamol/albuterol as rescue medication was permitted throughout the study. |
Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change From Baseline in Mean 24 Hour Heart Rate at Day 14
Time Frame: Baseline, Day 14
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Heart rate was assessed by Holter monitoring and was measured over a 24 hour period at day 14.
Heart rate was defined as the average value over the 24 hour monitoring period.
The baseline measurement was the average heart rate taken from the 24 hour Holter monitoring period performed at screening or the last 24-hour period before taking the first dose of study drug.
Least square means are based on the analysis of covariance: 24 hours mean heart rate = center + treatment + baseline value + Forced Expiratory Volume in one second (FEV1) before inhalation of salbutamol/albuterol + FEV1 30 min post salbutamol/albuterol + error.
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Baseline, Day 14
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change From Baseline in Mean 24 Hour Heart Rate at Day 1
Time Frame: Baseline, Day 1
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Heart rate was assessed by Holter monitoring and was measured over a 24 hour period at day 1.
Heart rate was defined as the average value over the 24 hour monitoring period.
The baseline measurement was the average heart rate taken from the 24 hour Holter monitoring period performed at screening or the last 24-hour period before taking the first dose of study drug.
Least squares means are based on the analysis of covariance: 24 hours mean heart rate = center + treatment + baseline value + Forced Expiratory Volume in one second (FEV1) before inhalation of salbutamol/albuterol + FEV1 30 min after inhalation of salbutamol/albuterol + error.
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Baseline, Day 1
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Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 1 and Day 14
Time Frame: Day 1, Day 14
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Spirometry testing was performed in accordance with American Thoracic Society standards.
Trough FEV1 was defined as the mean of two measurements at 23 hours 15 minutes and 23 hour 45 minutes post dosing.
Baseline is defined as the mean of the two values taken at 45 minutes and 15 minutes prior to dosing at day 1.
Least square means are based on the analysis of covariance: response variable=center + treatment + baseline value + Forced Expiratory Volume in one second (FEV1) before inhalation of salbutamol/albuterol + FEV1 30 minutes post inhalation of salbutamol/albuterol.
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Day 1, Day 14
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Trough Forced Vital Capacity (FVC) at Day 1 and Day 14
Time Frame: Day 1 and Day 14
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Spirometry testing was performed in accordance with American Thoracic Society standards.
Trough FVC was defined as the mean of two measurements at 23 hours 15 minutes and the 23 hours 45 minutes post dosing.
Baseline was defined as the mean of the two values taken at 45 minutes and 15 minutes prior to dosing at day 1.
Analysis of covariance: FVC parameter = center + treatment + baseline FVC + FEV1 before inhalation of salbutamol/albuterol + FEV1 30 min after inhalation of salbutamol/albuterol + error.
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Day 1 and Day 14
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Change From Baseline in QTc (Fridericia's Formula) at Day 1
Time Frame: Baseline, Day 1
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The change from baseline in QTc at 30 minutes, 4 hours and 23 hours 45 minutes post dose on day 1.
QT calculated (QTc) was calculated from the QT interval and RR (in seconds) using Fridericia's formula: QTc = QT / 3√ RR.
Least square means are based on the analysis of covariance: response variable = center + treatment + baseline value + FEV1 before inhalation of salbutamol/albuterol + FEV1 30 min post inhalation of salbutamol/albuterol.
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Baseline, Day 1
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Change From Baseline in QTc (Fridericia's Formula) at Day 7
Time Frame: Baseline, Day 7
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The change from baseline in QTc at 30 minutes and 2 hours post dose on day 7. QT calculated (QTc) was calculated from the QT interval and RR (in seconds) using Fridericia's formula: QTc = QT / 3√ RR.
Least square means are based on the analysis of covariance: response variable = center + treatment + baseline value + FEV1 before inhalation of salbutamol/albuterol + FEV1 30 min post inhalation of salbutamol/albuterol.
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Baseline, Day 7
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Change From Baseline in QTc (Fridericia's Formula) at Day 14
Time Frame: Baseline, Day 14
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The change from baseline in QTc at 30 minutes, 4 hours and 23 hours 45 minutes post dose on day 14.
QT calculated (QTc) was calculated from the QT interval and RR (in seconds) using Fridericia's formula: QTc = QT / 3√ RR.
Least square means are based on the analysis of covariance: response variable = center + treatment + baseline value + FEV1 before inhalation of salbutamol/albuterol + FEV1 30 minutes post inhalation of salbutamol/albuterol.
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Baseline, Day 14
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Lung Diseases
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Adjuvants, Anesthesia
- Glycopyrrolate
Other Study ID Numbers
- CQVA149A2203
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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