Chronic Obstructive Pulmonary Disease
Conditions
Keywords
COPD, Bronchodilator
Brief summary
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.
Interventions
DRUGPlacebo
Matching placebo capsules were supplied for inhalation once daily with Concept 1 device.
DRUGNVA237
NVA237 50 μg capsules were supplied for inhalation once daily with Concept 1 device.
Sponsors
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female aged greater than 40 years with COPD Current or ex-smokers
Exclusion criteria
* Cardiac (heart) disorders, history of asthma, requiring oxygen therapy. Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-24 Hours on Day 14 | From Day 1 to 0-24 hours after drug administration 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Forced Expiratory Volume in One Second (FEV1) AUC 0-12 Hours on Day 14 | From day 1 to 0 -12 hours after drug administration 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. |
| Forced Expiratory Volume in One Second (FEV1) AUC 12-24 Hours on Day 14 | From Day 1 to 12 hours-24 hours after drug administration 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. |
| Number of Participants Who Experienced Adverse Events (AEs), Serious Adverse Events (SAEs) | Day 14 | 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. |
Countries
Germany, United States
Participant flow
Pre-assignment details
Patients were randomized into one of two sequences to receive either NVA237 50 μg followed by placebo or placebo followed by NVA237 50 μg.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 33 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Period 2 | Abnormal test procedure results | 0 | 1 |
| Period 2 | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | All Randomized Patients |
|---|---|
| Age, Continuous | 60.5 years STANDARD_DEVIATION 9.13 |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 33 | 0 / 31 |
| serious Total, serious adverse events | 0 / 33 | 0 / 31 |
Outcome results
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.
Time frame: From Day 1 to 0-24 hours after drug administration on Day 14
Population: Efficacy analysis set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| NVA237 50μg | Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-24 Hours on Day 14 | 1.827 Liters | Standard Error 0.033 |
| Placebo | Forced Expiratory Volume in One Second (FEV1) Area Under Curve (AUC) 0-24 Hours on Day 14 | 1.664 Liters | Standard Error 0.0324 |
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.
Time frame: From day 1 to 0 -12 hours after drug administration on Day 14
Population: Efficacy analysis set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| NVA237 50μg | Forced Expiratory Volume in One Second (FEV1) AUC 0-12 Hours on Day 14 | 1.879 Liters | Standard Error 0.0346 |
| Placebo | Forced Expiratory Volume in One Second (FEV1) AUC 0-12 Hours on Day 14 | 1.714 Liters | Standard Error 0.034 |
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.
Time frame: From Day 1 to 12 hours-24 hours after drug administration on Day 14
Population: Efficacy analysis set
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| NVA237 50μg | Forced Expiratory Volume in One Second (FEV1) AUC 12-24 Hours on Day 14 | 1.776 Liters | Standard Error 0.0344 |
| Placebo | Forced Expiratory Volume in One Second (FEV1) AUC 12-24 Hours on Day 14 | 1.615 Liters | Standard Error 0.0339 |
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.
Time frame: Day 14
Population: Safety Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| NVA237 50μg | Number of Participants Who Experienced Adverse Events (AEs), Serious Adverse Events (SAEs) | Overall Adverse Events | 2 Participants |
| NVA237 50μg | Number of Participants Who Experienced Adverse Events (AEs), Serious Adverse Events (SAEs) | Serious Adverse Events (SAEs) | 0 Participants |
| Placebo | Number of Participants Who Experienced Adverse Events (AEs), Serious Adverse Events (SAEs) | Overall Adverse Events | 4 Participants |
| Placebo | Number of Participants Who Experienced Adverse Events (AEs), Serious Adverse Events (SAEs) | Serious Adverse Events (SAEs) | 0 Participants |