Safety and Tolerability of 28 Days Treatment With Glycopyrrolate(NVA237) (100 or 200µg Once a Day) in Patients With Moderate to Severe COPD
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Obstructive Pulmonary Disease (COPD)
Intervention: Glycopyrrolate (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis Pharmaceuticals, Study Chair, Affiliation: Novartis
Summary
This study will assess the safety/tolerability of 28 days of treatment with NVA237 100 and
200µg once a day, compared to placebo in patients with moderate or severe Chronic Obstructive
Pulmonary Disease (COPD).
Clinical Details
Official title: A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multi-Center Study, to Assess the Safety and Tolerability of 28 Days Treatment With NVA237 (100 or 200µg Once a Day) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Safety and tolerability of 28 days of treatment, based on all safety data including vital signs, ECGs, laboratory evaluations, spirometry and adverse events.
Secondary outcome: • Mean trough forced expiratory volume in 1 second (FEV1)at Day 28 and Day 1
• FEV1 over time for 8 time points on Day 1, Day 14 and Day 28
• Forced vital capacity (FVC) over time for 10 time points on Day 1 and Day 28 and 8 time points post-dosin
Eligibility
Minimum age: 40 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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 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
Exclusion Criteria:
- 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 1is
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
Locations and Contacts
Novartis, Rueil-Malmaison, France
Novartis, Nurnberg, Germany
Netherlands, Arnhem, Netherlands
Novartis, Barcelona, Spain
Novartis, Istanbul, Turkey
Pulmonary Associates, Phoenix, Arizona 85006, United States
Pulmonary Associates,, Glendale, Arizona 85306, United States
Rocky Mountain Center for Clinical Research, Wheat Ridge, Colorado 80033, United States
Lung Health & Sleep Enhancement Center, Newark, Delaware 19713, United States
Elite Research Institute, Miami, Florida 33169, United States
South Miami Clinical Research, Miami, Florida 33143, United States
Central Medical Group, Tamarac, Florida 33321, United States
Asthma and Allergy Center of Chicago, River Forest, Illinois 60305, United States
College Park Family Care Center., Overland Park, Kansas 66210-2761, United States
Midwest Chest Consultants., St. Chares, Missouri 63301, United States
American Health Research, Charlotte, North Carolina 28207, United States
Allergy Associates Research Center, Portland, Oregon 97213, United States
S Carolina Pharmaceutical Research, Spartanburg, South Carolina 29303, United States
Union Pharmaceutical Research, Union, South Carolina 29379, United States
F. Adam Kawley MD, Houston, Texas 77024, United States
Texas Pulmonary & Critical Care Consultants, Ft Worth, Texas 76104, United States
Additional Information
Starting date: August 2007
Ending date: January 2008
Last updated: January 15, 2008
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