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

NCT00510510 | Completed Phase 2 Results

• 1 other identifier: CNVA237A2206
• Study Type: interventional
• Target: 281
• Locations: 6 countries
• Sites: 21

Brief Summary

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).

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

COPD; glycopyrronium bromide; antimuscarinic

Outcome Measures

Primary Outcomes (1)

• Safety of Treatment With NVA237 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

  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.

  28 days

Secondary Outcomes (1)

• Least Squares Means of Trough Forced Expiratory Volume in One Second (FEV1), by Day

  28 Days

Study Arms (3)

NVA237 100 µg

EXPERIMENTAL

Drug: NVA237 100 µg

NVA237 200 µg

EXPERIMENTAL

Drug: NVA237 200 µg

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

NVA237 100 µg DRUG

Dry powder inhalation once a day for up to 28 days

Also known as: Glycopyrronium Bromide

NVA237 100 µg

Placebo DRUG

Placebo to NVA237 dry powder inhalation once a day for up to 28 days

Placebo

NVA237 200 µg DRUG

Dry powder inhalation once a day for up to 28 days

Also known as: Glycopyrronium Bromide

NVA237 200 µg

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis: lead

Study Sites (21)

Novartis investigative site

Glendale, Arizona, 85306, United States

Location

Novartis investigative site

Phoenix, Arizona, 85006, United States

Location

Novartis investigative site

Wheat Ridge, Colorado, 80033, United States

Location

Novartis investigative site

Newark, Delaware, 19713, United States

Location

Novartis investigative site

Miami, Florida, 33143, United States

Location

Novartis investigative site

Miami, Florida, 33169, United States

Location

Novartis investigative site

Tamarac, Florida, 33321, United States

Location

Novartis investigative site

River Forest, Illinois, 60305, United States

Location

Novartis investigative site

Overland Park, Kansas, 66210-2761, United States

Location

Novartis investigative site

Saint Chares, Missouri, 63301, United States

Location

Novartis investigative site

Charlotte, North Carolina, 28207, United States

Location

Novartis investigative site

Portland, Oregon, 97213, United States

Location

Novartis investigative site

Spartanburg, South Carolina, 29303, United States

Location

Novartis investigative site

Union, South Carolina, 29379, United States

Location

Novartis investigative site

Fort Worth, Texas, 76104, United States

Location

Novartis investigative site

Houston, Texas, 77024, United States

Location

Novartis investigative site

Rueil-Malmaison, France

Location

Novartis investigative site

Nuremberg, Germany

Location

Novartis investigative site

Arnhem, Netherlands

Location

Novartis investigative site

Barcelona, Spain

Location

Novartis investigative site

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• Vogelmeier C, Verkindre C, Cheung D, Galdiz JB, Guclu 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.

  PMID: 20416390 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Glycopyrrolate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2007
• First Posted: August 2, 2007
• Study Start: August 1, 2007
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: May 21, 2012
• Results First Posted: January 21, 2011

Record last verified: 2012-05

Locations

NL (1); US (16); DE (1); FR (1); TU (1); ES (1)