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)
NCT ID: NCT00558285
Last Updated: 2012-11-30
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
257 participants
INTERVENTIONAL
2007-11-30
2008-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
indacaterol/glycopyrrolate
Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.
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.
indacaterol/glycopyrrolate
Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.
placebo
Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.
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.
indacaterol/glycopyrrolate
Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.
glycopyrrolate
Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.
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.
indacaterol
Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.
placebo
Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.
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.
placebo
Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.
Interventions
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indacaterol/glycopyrrolate
Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.
indacaterol
Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.
glycopyrrolate
Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.
placebo
Inhalation capsule delivered via a single dose dry powder inhaler in the morning for 14 days.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharma AG
Role: STUDY_CHAIR
Novartis Pharmaceuticals
Locations
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Novartis Investigator Site
Adelaide, , Australia
Novartis Investigator Site
Clayton, , Australia
Novartis Investigator Site
Daw Park, , Australia
Novartis Investigator site
Heidelberg, , Australia
Novartis Investigator Site
Nedlands, , Australia
Novartis Investigator Site
Brussels, , Belgium
Novartis Investigator Site
Jambes, , Belgium
Novartis Investigator Site
Jette, , Belgium
Novartis Investigator site
Liège, , Belgium
Novartis Investigator Site
Ostend, , Belgium
Novartis Investigator Site
Mississauga, , Canada
Novartis Investigator Site
Newmarket, , Canada
Novartis Investigator Site
Ottawa, , Canada
Novartis Investigator Site
Pointe-Claire, , Canada
Novartis Investigator Site
Québec, , Canada
Novartis Investigator Site
Sainte-Foy, , Canada
Novartis Investigator Site
Ambroise, , France
Novartis Investigator Site
Lille, , France
Novartis Investigator Site
Marseille, , France
Novartis investigator site
Martigues, , France
Novartis Investigator Site
Nantes, , France
Novartis Investigator site
Nice, , France
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Perpignan, , France
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Berlin, , Germany
Novartis Investigator Site
Dortmund, , Germany
Novartis Investigator Site
Erfurt, , Germany
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Hanover, , Germany
Novartis Investigator Site
Mainz, , Germany
Novartis Investigator Site
Marburg, , Germany
Novartis Investigator Site
Florence, , Italy
Novartis Investigator site
Modena, , Italy
Novartis Investigator Site
Trieste, , Italy
Novartis Investigator Site
Badalona, , Spain
Novartis Investigator Site
Barakaldo, , Spain
Novartis Investigator Site
Cáceres, , Spain
Novartis Investigator Site
Centelles, , Spain
Novartis Investigator Site
Mataró, , Spain
Novartis Investigator Site
Valencia, , Spain
Novartis Investigator Site
Istanbul, , Turkey (Türkiye)
Novartis Investigator Site
Izmir, , Turkey (Türkiye)
Countries
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Other Identifiers
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CQVA149A2203
Identifier Type: -
Identifier Source: org_study_id