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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NVA237 100 µg | Experimental |
| |
| NVA237 200 µg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NVA237 100 µg | Drug | Dry powder inhalation once a day for up to 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Least Squares Means of Trough Forced Expiratory Volume in One Second (FEV1), by Day | 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. | 28 Days |
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Inclusion Criteria:
Exclusion Criteria:
Blood eosinophil count > 400/mm3, onset of symptoms prior to age 40 years.
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis investigative site | Glendale | Arizona | 85306 | United States | ||
| Novartis investigative site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20416390 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | NVA237 100 µg | NVA237 100 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days. |
| FG001 | NVA237 200 µg | NVA237 200 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Placebo to NVA237 dry powder inhalation once a day for up to 28 days |
|
| NVA237 200 µg | Drug | Dry powder inhalation once a day for up to 28 days |
|
|
| Phoenix |
| Arizona |
| 85006 |
| United States |
| Novartis investigative site | Wheat Ridge | Colorado | 80033 | United States |
| Novartis investigative site | Newark | Delaware | 19713 | United States |
| Novartis investigative site | Miami | Florida | 33143 | United States |
| Novartis investigative site | Miami | Florida | 33169 | United States |
| Novartis investigative site | Tamarac | Florida | 33321 | United States |
| Novartis investigative site | River Forest | Illinois | 60305 | United States |
| Novartis investigative site | Overland Park | Kansas | 66210-2761 | United States |
| Novartis investigative site | Saint Chares | Missouri | 63301 | United States |
| Novartis investigative site | Charlotte | North Carolina | 28207 | United States |
| Novartis investigative site | Portland | Oregon | 97213 | United States |
| Novartis investigative site | Spartanburg | South Carolina | 29303 | United States |
| Novartis investigative site | Union | South Carolina | 29379 | United States |
| Novartis investigative site | Fort Worth | Texas | 76104 | United States |
| Novartis investigative site | Houston | Texas | 77024 | United States |
| Novartis investigative site | Rueil-Malmaison | France |
| Novartis investigative site | Nuremberg | Germany |
| Novartis investigative site | Arnhem | Netherlands |
| Novartis investigative site | Barcelona | Spain |
| Novartis investigative site | Istanbul | Turkey (Türkiye) |
| FG002 | Placebo | Matching placebo to NVA237 as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | NVA237 100 µg | NVA237 100 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.. |
| BG001 | NVA237 200 µg | NVA237 200 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days. |
| BG002 | Placebo | Matching placebo to NVA237 as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | Participants | 28 days |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Least Squares Means of Trough Forced Expiratory Volume in One Second (FEV1), by Day | 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. | Posted | Least Squares Mean | Standard Error | Liters | 28 Days |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NVA237 100 µg | NVA237 100 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.. | 0 | 92 | 7 | 92 | ||
| EG001 | NVA237 200 µg | NVA237 200 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days. | 1 | 98 | 10 | 98 | ||
| EG002 | Placebo | Matching placebo to NVA237 as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days. | 1 | 91 | 4 | 91 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment | Chronic obstructive pulmonary disease exacerbation |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry mouth | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D006024 | Glycopyrrolate |
| ID | Term |
|---|---|
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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