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

August 1, 2007
May 14, 2012
August 2007
January 2008   (final data collection date for primary outcome measure)
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.
Safety and tolerability of 28 days of treatment, based on all safety data including vital signs, ECGs, laboratory evaluations, spirometry and adverse events.
Complete list of historical versions of study NCT00510510 on ClinicalTrials.gov Archive Site
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.
• 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
Not Provided
Not Provided
 
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
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)

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).

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease (COPD)
  • Drug: NVA237 100 µg
    Dry powder inhalation once a day for up to 28 days
    Other Name: Glycopyrronium Bromide
  • 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
    Other Name: Glycopyrronium Bromide
  • Experimental: NVA237 100 µg
    Intervention: Drug: NVA237 100 µg
  • Experimental: NVA237 200 µg
    Intervention: Drug: NVA237 200 µg
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Vogelmeier C, Verkindre C, Cheung D, Galdiz JB, Güçlü SZ, Spangenthal S, Overend T, Henley M, Mizutani G, Zeldin RK. Safety and tolerability of NVA237, a once-daily long-acting muscarinic antagonist, in COPD patients. Pulm Pharmacol Ther. 2010 Oct;23(5):438-44. doi: 10.1016/j.pupt.2010.04.005. Epub 2010 Apr 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
281
January 2008
January 2008   (final data collection date for primary outcome measure)

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

Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Turkey,   France,   Germany,   Netherlands,   Spain
 
NCT00510510
CNVA237A2206
Not Provided
Novartis
Novartis
Not Provided
Study Chair: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP