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

Overview

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).

Full Title of Study: “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)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: January 2008

Interventions

  • Drug: NVA237 100 µg
    • Dry powder inhalation once a day for up to 28 days
  • Drug: Placebo
    • Placebo to NVA237 dry powder inhalation once a day for up to 28 days
  • Drug: NVA237 200 µg
    • Dry powder inhalation once a day for up to 28 days

Arms, Groups and Cohorts

  • Experimental: NVA237 100 µg
  • Experimental: NVA237 200 µg
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Safety of Treatment With NVA237 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
    • Time Frame: 28 days
    • 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 Measures

  • Least Squares Means of Trough Forced Expiratory Volume in One Second (FEV1), by Day
    • Time Frame: 28 Days
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Novartis
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Novartis Pharmaceuticals, Study Chair, Novartis Pharmaceuticals

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