Safety and Tolerability of 28 Days Treatment With Glycopyrronium Bromide (NVA237) (100 or 200 µg Once a Day) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease (COPD)

In brief

This study assessed the safety/tolerability of 28 days of treatment with NVA237 100 µg and 200 µg once a day, compared to placebo in patients with moderate or severe Chronic Obstructive Pulmonary Disease (COPD).

Key facts

Study ID

NCT00510510

Run by

Novartis

People needed

281

Starts

2007-08-01

Expected to finish

2008-01-01

Last updated by the study team

2012-05-21

Who can join

Age: 40 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female adults aged 40 years or older
• Patients with moderate to severe COPD according to the 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) equal or greater than 30% of the predicted normal value and less than 80% of the predicted normal value, and post-bronchodilator FEV1/FVC less than 0.7 at visit 2
• Written informed consent by the patient prior to initiation of any study-related procedure

You may not qualify if…

• Patients requiring oxygen therapy on a daily basis for chronic hypoxemia, or who have been hospitalized for an exacerbation of their airways disease in the 6 weeks prior to visit 1 or during the screening period (up to visit 3).
• Patients who have had a respiratory tract infection within 6 weeks prior to visit 1 or during the screening period (up to visit 3).
• Patients with a history of asthma indicated by (but not limited to):
• Blood eosinophil count > 400/mm3, onset of symptoms prior to age 40 years.
• Patients with a history of long QT syndrome or whose QTc measured at visit 1 is prolonged (more than 440 ms for males or more than 460 ms for females).
• Patients with a history of untoward reactions to sympathomimetic amines or inhaled medication or any component thereof.
• Patients who, in the judgment of the investigator have a clinically relevant laboratory abnormality or a clinically significant condition such as (but not limited to) unstable ischemic heart disease, left ventricular failure, long term prednisone therapy, history of myocardial infarction, arrhythmia, narrow-angle glaucoma, symptomatic prostatic hyperplasia, bladder-neck obstruction or moderate to severe renal impairment that might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study.
• History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin.
• Other protocol-defined inclusion/exclusion criteria may apply

Where it is running

• Novartis investigative site — Glendale, Arizona, United States
• Novartis investigative site — Phoenix, Arizona, United States
• Novartis investigative site — Wheat Ridge, Colorado, United States
• Novartis investigative site — Newark, Delaware, United States
• Novartis investigative site — Miami, Florida, United States
• Novartis investigative site — Miami, Florida, United States
• Novartis investigative site — Tamarac, Florida, United States
• Novartis investigative site — River Forest, Illinois, United States
• Novartis investigative site — Overland Park, Kansas, United States
• Novartis investigative site — Saint Chares, Missouri, United States
• Novartis investigative site — Charlotte, North Carolina, United States
• Novartis investigative site — Portland, Oregon, United States
• Novartis investigative site — Spartanburg, South Carolina, United States
• Novartis investigative site — Union, South Carolina, United States
• Novartis investigative site — Fort Worth, Texas, United States
• Novartis investigative site — Houston, Texas, United States
• Novartis investigative site — Rueil-Malmaison, France
• Novartis investigative site — Nuremberg, Germany
• Novartis investigative site — Arnhem, Netherlands
• Novartis investigative site — Barcelona, Spain
• Novartis investigative site — Istanbul, Turkey (Türkiye)

Full record on ClinicalTrials.gov

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