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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-006849-28 | EudraCT Number |
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This study was intended to assess how well inhaled NVA237 opens up the airways of patients with mild, moderate or severe COPD over a 24 hour period after a 14 day treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo then NVA237 50μg | Placebo Comparator | Placebo 50 μg capsules followed by NVA237 50 μg capsules for inhalation once daily with Concept 1 device. |
|
| NVA237 50μg then placebo | Experimental | NVA237 50 μg capsules followed by matching placebo 50 μg capsules for inhalation once daily with Concept 1 device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Matching placebo capsules were supplied for inhalation once daily with Concept 1 device. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-24 Hours on Day 14 | Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change is FEV1 from predose (day 1) to the readings taken 0-24 hours post dose on day 14. The variable was analyzed with an analysis-of-covariance model which included baseline FEV1 value as a covariate. | From Day 1 to 0-24 hours after drug administration on Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Forced Expiratory Volume in One Second (FEV1) AUC 0-12 Hours on Day 14 | Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change is FEV1 from pre-dose (day 1) to the readings taken 0-12 hours post dose on day 14. The variable was analyzed with an analysis-of-covariance model which included baseline FEV1 value as a covariate. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Spartanburg Medical Research | Spartanburg | South Carolina | 29303 | United States | ||
| Harrison Clinical Research Deutschland GmbH |
Patients were randomized into one of two sequences to receive either NVA237 50 μg followed by placebo or placebo followed by NVA237 50 μg.
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| ID | Title | Description |
|---|---|---|
| FG000 | NVA237 50μg Then Placebo | NVA237 50 μg capsules followed by matching placebo 50 μg capsules for inhalation once daily with Concept 1 device. |
| FG001 | Placebo Then NVA237 50μg | Placebo 50 µg capsules followed by NVA237 50 µg capsules for inhalation once daily with Concept 1 device. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| |||||||||||||
| Period 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Randomized Patients | NVA237 50 μg capsules for inhalation once daily with Concept 1 device. Matching placebo 50 µg capsules for inhalation once daily with Concept 1 device. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-24 Hours on Day 14 | Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change is FEV1 from predose (day 1) to the readings taken 0-24 hours post dose on day 14. The variable was analyzed with an analysis-of-covariance model which included baseline FEV1 value as a covariate. | Efficacy analysis set | Posted | Least Squares Mean | Standard Error | Liters | From Day 1 to 0-24 hours after drug administration on Day 14 |
|
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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 | Placebo | Matching placebo capsules were supplied by Novartis for inhalation once daily with Concept 1 device. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal disorders | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 862-778-8300 |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D006024 | Glycopyrrolate |
| ID | Term |
|---|---|
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009861 | Onium Compounds |
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| NVA237 | Drug | NVA237 50 μg capsules were supplied for inhalation once daily with Concept 1 device. |
|
| From day 1 to 0 -12 hours after drug administration on Day 14 |
| Forced Expiratory Volume in One Second (FEV1) AUC 12-24 Hours on Day 14 | Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change is FEV1 from pre-dose (day 1) to the readings taken 12-24 hours post dose on day 14. The variable was analyzed with an analysis-of-covariance model which included baseline FEV1 value as a covariate. | From Day 1 to 12 hours-24 hours after drug administration on Day 14 |
| Number of Participants Who Experienced Adverse Events (AEs), Serious Adverse Events (SAEs) | According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening , causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above. See Adverse Events module for details. | Day 14 |
| Albrechtstrasse 14 |
| Munich |
| 80636 |
| Germany |
| NOT COMPLETED |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Matching placebo capsules were supplied by Novartis for inhalation once daily with Concept 1 device. |
|
|
| Secondary | Forced Expiratory Volume in One Second (FEV1) AUC 0-12 Hours on Day 14 | Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change is FEV1 from pre-dose (day 1) to the readings taken 0-12 hours post dose on day 14. The variable was analyzed with an analysis-of-covariance model which included baseline FEV1 value as a covariate. | Efficacy analysis set | Posted | Least Squares Mean | Standard Error | Liters | From day 1 to 0 -12 hours after drug administration on Day 14 |
|
|
|
| Secondary | Forced Expiratory Volume in One Second (FEV1) AUC 12-24 Hours on Day 14 | Forced Expiratory Volume in one second (FEV1) was calculated as the volume of air forcibly exhaled in one second as measured by a spirometer. This outcome measures the change is FEV1 from pre-dose (day 1) to the readings taken 12-24 hours post dose on day 14. The variable was analyzed with an analysis-of-covariance model which included baseline FEV1 value as a covariate. | Efficacy analysis set | Posted | Least Squares Mean | Standard Error | Liters | From Day 1 to 12 hours-24 hours after drug administration on Day 14 |
|
|
|
| Secondary | Number of Participants Who Experienced Adverse Events (AEs), Serious Adverse Events (SAEs) | According to FDA 21CFR 314.80, a serious adverse event (SAE) is described as any adverse event that leads to death, is life threatening , causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event not described above. See Adverse Events module for details. | Safety Population | Posted | Number | Participants | Day 14 |
|
|
|
| 0 |
| 33 |
| 2 |
| 33 |
| EG001 | NVA237 50 μg | NVA237 50 μg capsules were supplied by Novartis for inhalation once daily with Concept 1 device. | 0 | 31 | 0 | 31 |
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.
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011759 |
| Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |