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Safety and Tolerability of 28 Days Treatment With Glycopyrrolate(NVA237) (100 or 200µg Once a Day) in Patients With Moderate to Severe COPD
This study has been completed.
First Received: August 1, 2007   Last Updated: January 15, 2008   History of Changes
Sponsor: Novartis
Information provided by: Novartis
ClinicalTrials.gov Identifier: NCT00510510
  Purpose

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).


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
Drug: Glycopyrrolate
Phase II

Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
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)

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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 Measures:
  • • 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

Estimated Enrollment: 240
Study Start Date: August 2007
Study Completion Date: January 2008
  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00510510

  Show 21 Study Locations
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: novartis ( external affairs )
Study ID Numbers: CNVA237A2206
Study First Received: August 1, 2007
Last Updated: January 15, 2008
ClinicalTrials.gov Identifier: NCT00510510     History of Changes
Health Authority: United States: Food and Drug Administration;   Germany: Federal Institute for Drugs and Medical Devices;   France: Afssaps - French Health Products Safety Agency;   Netherlands: Medicines Evaluation Board (MEB);   Spain: Spanish Agency of Medicines;   Turkey: Ministry of Health

Keywords provided by Novartis:
COPD, Glycopyrrolate, antimuscarinic

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Physiological Effects of Drugs
Respiration Disorders
Cholinergic Agents
Pharmacologic Actions
Adjuvants, Anesthesia
Muscarinic Antagonists
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Glycopyrrolate
Therapeutic Uses
Central Nervous System Agents
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on November 09, 2009