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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT00510510
First received: August 1, 2007
Last updated: May 14, 2012
Last verified: May 2012
  Purpose

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).


Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
Drug: NVA237 100 µg
Drug: Placebo
Drug: NVA237 200 µg
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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 200 µg 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 of Treatment With NVA237 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    The assessment of safety was based on adverse events, particularly those adverse events known to be associated to treatment with muscarinic antagonists. A summary of adverse events is presented with this outcome, additional details are provided in Adverse Events Sections.


Secondary Outcome Measures:
  • Least Squares Means of Trough Forced Expiratory Volume in One Second (FEV1), by Day [ Time Frame: 28 Days ] [ Designated as safety issue: No ]
    Forced expiratory volume maneuvers recorded using a calibrated spirometer. Trough forced expiratory volume in one second (FEV1) on Days 1 & 28 defined as the mean of the FEV1 values measured at 23 hours 15 minutes and 23 hours 45 minutes post-dose.


Enrollment: 281
Study Start Date: August 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NVA237 100 µg Drug: NVA237 100 µg
Dry powder inhalation once a day for up to 28 days
Other Name: Glycopyrronium Bromide
Experimental: NVA237 200 µg Drug: NVA237 200 µg
Dry powder inhalation once a day for up to 28 days
Other Name: Glycopyrronium Bromide
Placebo Comparator: Placebo Drug: Placebo
Placebo to NVA237 dry powder inhalation once a day for up to 28 days

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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

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 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

  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 by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00510510     History of Changes
Other Study ID Numbers: CNVA237A2206
Study First Received: August 1, 2007
Results First Received: December 23, 2010
Last Updated: May 14, 2012
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Netherlands: Medicines Evaluation Board (MEB)
Spain: Spanish Agency of Medicines
Turkey: Ministry of Health

Keywords provided by Novartis:
COPD
glycopyrronium bromide
antimuscarinic

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

ClinicalTrials.gov processed this record on April 23, 2014