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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-018987-17 | EudraCT Number |
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The study assessed the safety and ability of an orally inhaled medicine [i.e., Glycopyrrolate Inhalation Solution = GIS] to improve airflow in the lungs when delivered using an eFlow nebulizer in 42 patients with Chronic Obstructive Pulmonary Disease (COPD). Each patient randomly received several, single doses of GIS, or placebo, separated by approximately 1 to 2 weeks. After the dose was given, lung airflow was measured over 24 hours and blood was collected to measure how much GIS was in the bloodstream. The study was conducted to find the once-a- day GIS dose that produced the highest improvement in lung airflow using the eFlow nebulizer.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glycopyrrolate Inhalation Solution12.5μg | Experimental | Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily |
|
| Glycopyrrolate Inhalation Solution 50μg | Experimental | Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily |
|
| Glycopyrrolate Inhalation Solution 100μg | Experimental | Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily |
|
| Glycopyrrolate Inhalation Solution 200μg | Experimental | Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily |
|
| Glycopyrrolate Inhalation Solution 400μg | Experimental | Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glycopyrrolate Inhalation Solution12.5μg | Drug | Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Trough FEV1 (Change From Baseline) | Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. Trough FEV1 was defined as the mean of FEV1 values obtained at 23 hours 30 minutes and 24 hours post-dose of each Treatment Visit. | 24hr post dose |
| Standardized FEV1AUC0-12 Area Under the FEV1 Curve From 0 to 12 Hours Post-dose ( Actual and Change From Baseline). | Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.. The standardized actual FEV1 AUC(0-12) was calculated using the trapezoidal rule divided by the actual hours from the first FEV1 to the last FEV1 in the interval. Standardized change from baseline FEV1 AUC(0-12) was also calculated similarly, using the change from pre-dose FEV1. | 0-12h post dose |
| Standardized FEV1AUC12-24 Area Under the FEV1 Curve From 12 to 24 Hours Post- Dose (Actual and Change From Baseline). | Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. The standardized actual FEV1 AUC(12-24) was calculated using the trapezoidal rule divided by the actual hours from the first FEV1 to the last FEV1 in the interval. Standardized change from baseline FEV1 AUC(12-24) was also calculated similarly, using the change from pre-dose FEV1. | 12-24h post dose |
| Standardized FEV1 AUC0-24 Area Under the FEV1 Curve From 0 to 24 Hours Post-dose (Actual and Change Baseline) | Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. . The standardized actual FEV1 AUC(0-24) was calculated using the trapezoidal rule divided by the actual hours from the first FEV1 to the last FEV1 in the interval. Standardized change from baseline FEV1 AUC(0-24) was also calculated similarly, using the change from pre-dose FEV1. | 0 to 24h |
| Peak FEV1 (Change From Baseline and Percent Change) |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax; Maximum Observed Plasma Concentration | Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr | 0 to 12 hour |
| Tmax; Time to Maximum Observed Plasma Concentration |
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Inclusion Criteria:
Exclusion Criteria:
Females who are pregnant or lactating at the Screening Visit, or if of childbearing potential not using one of the following acceptable means of birth control throughout the study:
Current evidence or recent history of any clinically significant disease (other than COPD) or abnormality in the opinion of the Investigator that would put the subject at risk or which would compromise the quality of the study data; including but not limited to cardiovascular disease, myocardial infarction, cardiac failure, uncontrolled hypertension, life-threatening arrhythmias, uncontrolled diabetes, neurologic or neuromuscular disease, liver disease, gastrointestinal disease or electrolyte abnormalities
Recent history of hospitalization due to an exacerbation of airway disease within 3 months or need for increased treatments for COPD within 6 weeks prior to the Screening Visit
Primary diagnosis of asthma
Prior lung volume reduction surgery or history of chest/lung irradiation
Regular use of daily oxygen therapy
Use of systemic (eg, intramuscular or intravenous) steroids within 3 months prior to the Screening Visit
Respiratory tract infection within 6 weeks prior to the Screening Visit
History of tuberculosis, bronchiectasis or other non- specific pulmonary disease
History of urinary retention or bladder neck obstruction type symptoms
History of narrow-angle glaucoma
Clinically significant abnormal ECG
Positive Hepatitis B surface antigen or positive Hepatitis C antibody
Positive screening test for HIV antibodies
Current or recent history (previous 12 months) of excessive use or abuse of alcohol
Current evidence or history of abusing legal drugs or use of illegal drugs or substances
Donation of 450 mL of blood within 8 weeks of the Screening Visit
History of hypersensitivity or intolerance to aerosol medications
Participation in another investigational drug study was received within 30 days prior to the Screening Visit
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| Name | Affiliation | Role |
|---|---|---|
| Ahmet Tutuncu, MD, PhD | Elevation Pharmaceuticals, Inc., (now known as Sunovion Respriatory Developement Inc.) | Study Chair |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25243340 | Result | Leaker BR, Barnes PJ, Jones CR, Tutuncu A, Singh D. Efficacy and safety of nebulized glycopyrrolate for administration using a high efficiency nebulizer in patients with chronic obstructive pulmonary disease. Br J Clin Pharmacol. 2015 Mar;79(3):492-500. doi: 10.1111/bcp.12517. |
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All enrolled subjects were randomized. all randomized subjects received at least one dose of study medication
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Group 1 | subjects received placebo, glycopyrrolate 400mcg, glycopyrrolate 50 mcg, glycopyrrolate 12.5 mcg, glycoyrrolate 200mcg, or glycopryrrolate 100mcg |
| FG001 | Treatment Group 2 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
|
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| Placebo 0.5mL |
| Placebo Comparator |
Placebo 0.5mL via e-flow nebulizer, once daily |
|
| Glycopyrrolate Inhalation Solution 50μg | Drug | Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily |
|
|
| Glycopyrrolate Inhalation Solution 100μg | Drug | Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily |
|
|
| Glycopyrrolate Inhalation Solution 200μg | Drug | Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily |
|
|
| Glycopyrrolate Inhalation Solution 400μg | Drug | Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily |
|
|
| Placebo 0.5mL | Drug | Placebo 0.5mL via eFlow, once daily |
|
|
spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. . The peak FEV1 was defined as the highest post-dose FEV1 value within 4 hrs after the dose. Percent change from baseline was calculated as 100 times the difference of peak FEV1 minus baseline FEV1 divided by baseline FEV1. |
| 0-4h post dose |
Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr
| 0 to 12 hours |
| t1/2; Plasma Half-life | Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr | 0 to 12 hour |
| AUC0-t; Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Measurable Drug Concentration. | Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr | 0 to 12 hour |
| AUC0-inf Area Under the Plasma Concentration-time Curve From Time Zero to Infinity | Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr | 0 to 12 hour |
| Number of Subjects Who Died, Number of Subjects With Treatment Emergent SAEs, Number of Subjects Who Discontinued Due to AE | AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment | Day 69 (includes dosing Day 1, washout Day 12, safety follow up Day 69) |
| Number of Subjects With Clinically Significant Abnormal Vital Signs Reported During the Study | Vital signs were measured at screening and at each Treatment Visit pre-dose (within 30 minutes prior to dose); post-dose at 30 minutes and 1, 2, 4, 8, 12 and 24 hours; and then at the post study assessment. | 0-24 h |
| Number of Clinically Significant Abnormal Laboratory Results Reported During the Study | Clinical safety lab parameters were collected at screening and at the post study assessment. Any laboratory values that were out of range of normal reference values were evaluated by the Investigators. | Day -14, Day 69 |
| Number of Subjects With Clinically Significant ECG Parameters Reported During the Study | ECGs were recorded at screening and at each study treatment visit pre-dose (within 30 minutes prior to dose); post-dose at 30 minutes and 1, 2, 4, 8, 12 and 24 hours; and then at the post study assessment. | 0 to 24h |
| Percentage of Subjects With Treatment Emergent AEs | AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment | Day 69 (includes dosing Day 1, washout Day 12, safety follow up Day 69) |
subjects received glycopyrrolate 12.5 mcg, glycopyrrolate 50 mcg, glycopryrrolate 100mcg, placebo, glycopyrrolate 200mcg, glycoyrrolate 400mcg, or placebo
| FG002 | Treatment Group 3 | subjects received glycopyrrolate 50 mcg, Placebo, glycopyrrolate 200 mcg, glycopryrrolate 100mcg, glycopyrrolate 12.5mcg, or glycoyrrolate 400mcg |
| FG003 | Treatment Group 4 | subjects received glycopyrrolate 100 mcg, glycopyrrolate 200 mcg, glycopryrrolate 400mcg, placebo, glycopyrrolate 50mcg, or glycoyrrolate 12.5mcg |
| FG004 | Treatment Group 5 | subjects received glycopyrrolate 200 mcg, glycopyrrolate 12.5 mcg, placebo, glycopryrrolate 400mcg, placebo, glycopyrrolate 100mcg, or glycoyrrolate 50mcg |
| FG005 | Treatment Group 6 | subjects received glycopyrrolate 400 mcg, glycopyrrolate 100 mcg, glycopryrrolate 12.5mcg, glycopyrrolate 50mcg, placebo or glycoyrrolate 200mcg |
| COMPLETED |
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| NOT COMPLETED |
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| Washout Period 1 |
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| Treatment Period 2 |
|
| Washout Period 2 |
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| Treatment Period 3 |
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| Washout Period 3 |
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| Treatment Period 4 |
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| Washout Period 4 |
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| Treatment Period 5 |
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| Washout Period 5 |
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| Treatment Period 6 |
|
| Wshout Period 6 |
|
Intent to treat population same as safety population -not full analysis set
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| ID | Title | Description |
|---|---|---|
| BG000 | Total Participants | Intent to treat population same as safety population -not full analysis set |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| 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 |
| ||||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants | No |
|
| 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 | Trough FEV1 (Change From Baseline) | Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. Trough FEV1 was defined as the mean of FEV1 values obtained at 23 hours 30 minutes and 24 hours post-dose of each Treatment Visit. | All subjects who received at least one dose of study medication and had at least one postbaseline efficacy measurement (FEV1) were included in the intent-to-treat analysis. | Posted | Mean | Standard Deviation | liters | 24hr post dose |
|
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Standardized FEV1AUC0-12 Area Under the FEV1 Curve From 0 to 12 Hours Post-dose ( Actual and Change From Baseline). | Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.. The standardized actual FEV1 AUC(0-12) was calculated using the trapezoidal rule divided by the actual hours from the first FEV1 to the last FEV1 in the interval. Standardized change from baseline FEV1 AUC(0-12) was also calculated similarly, using the change from pre-dose FEV1. | All subjects who received at least one dose of study medication and had at least one postbaseline efficacy measurement (FEV1) were included in the intent to treat analysis | Posted | Mean | Standard Deviation | liters | 0-12h post dose |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Standardized FEV1AUC12-24 Area Under the FEV1 Curve From 12 to 24 Hours Post- Dose (Actual and Change From Baseline). | Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. The standardized actual FEV1 AUC(12-24) was calculated using the trapezoidal rule divided by the actual hours from the first FEV1 to the last FEV1 in the interval. Standardized change from baseline FEV1 AUC(12-24) was also calculated similarly, using the change from pre-dose FEV1. | All subjects who received at least one dose of study medication and had at least one postbaseline efficacy measurement (FEV1) were included in the intent to treat analysis | Posted | Mean | Standard Deviation | liters | 12-24h post dose |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Standardized FEV1 AUC0-24 Area Under the FEV1 Curve From 0 to 24 Hours Post-dose (Actual and Change Baseline) | Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. . The standardized actual FEV1 AUC(0-24) was calculated using the trapezoidal rule divided by the actual hours from the first FEV1 to the last FEV1 in the interval. Standardized change from baseline FEV1 AUC(0-24) was also calculated similarly, using the change from pre-dose FEV1. | all subjects who received at least one dose of study medication and had at least one postbaseline efficacy measurement (FEV1) were included in the intent to treat analysis | Posted | Mean | Standard Deviation | liters | 0 to 24h |
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| Primary | Peak FEV1 (Change From Baseline and Percent Change) | spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. . The peak FEV1 was defined as the highest post-dose FEV1 value within 4 hrs after the dose. Percent change from baseline was calculated as 100 times the difference of peak FEV1 minus baseline FEV1 divided by baseline FEV1. | all subjects who received at least one dose of study medication and have at least one post baseline efficacy measurement were included in the efficacy population | Posted | Mean | Standard Deviation | liters | 0-4h post dose |
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| Secondary | Cmax; Maximum Observed Plasma Concentration | Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr | All subjects who received at least one dose of EP-101 and who have sufficient blood samples taken to obtain a plasma concentration by time profile and have no major protocol violations were included in the PK analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/mL | 0 to 12 hour |
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| Secondary | Tmax; Time to Maximum Observed Plasma Concentration | Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr | All subjects who received at least one dose of EP-101 and who have sufficient blood samples taken to obtain a plasma concentration by time profile and have no major protocol violations were included in the PK analysis. | Posted | Median | Full Range | hours | 0 to 12 hours |
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| Secondary | t1/2; Plasma Half-life | Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr | All subjects who received at least one dose of EP-101 and who have sufficient blood samples taken to obtain a plasma concentration by time profile and have no major protocol violations were included in the PK analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | 0 to 12 hour |
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| Secondary | AUC0-t; Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Measurable Drug Concentration. | Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr | All subjects who received at least one dose of EP-101 and who have sufficient blood samples taken to obtain a plasma concentration by time profile and have no major protocol violations were included in the PK analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | pg.h/ml | 0 to 12 hour |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | AUC0-inf Area Under the Plasma Concentration-time Curve From Time Zero to Infinity | Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr | All subjects who received at least one dose of EP-101 and who have sufficient blood samples taken to obtain a plasma concentration by time profile and have no major protocol violations were included in the PK analysis. | Posted | Geometric Mean | Geometric Coefficient of Variation | pg.h/ml | 0 to 12 hour |
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| Secondary | Number of Subjects Who Died, Number of Subjects With Treatment Emergent SAEs, Number of Subjects Who Discontinued Due to AE | AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment | all subjects who received at least one dose of study drug were included in the safety analysis | Posted | Number | participants | Day 69 (includes dosing Day 1, washout Day 12, safety follow up Day 69) |
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| Secondary | Number of Subjects With Clinically Significant Abnormal Vital Signs Reported During the Study | Vital signs were measured at screening and at each Treatment Visit pre-dose (within 30 minutes prior to dose); post-dose at 30 minutes and 1, 2, 4, 8, 12 and 24 hours; and then at the post study assessment. | all subjects who received at least one does of study drug were included in the safety analysis | Posted | Count of Participants | Participants | 0-24 h |
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| Secondary | Number of Clinically Significant Abnormal Laboratory Results Reported During the Study | Clinical safety lab parameters were collected at screening and at the post study assessment. Any laboratory values that were out of range of normal reference values were evaluated by the Investigators. | all subjects who received at least one dose of study drug were included in the safety analysis | Posted | Number | number of events | Day -14, Day 69 |
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| Secondary | Number of Subjects With Clinically Significant ECG Parameters Reported During the Study | ECGs were recorded at screening and at each study treatment visit pre-dose (within 30 minutes prior to dose); post-dose at 30 minutes and 1, 2, 4, 8, 12 and 24 hours; and then at the post study assessment. | all subjects who received at least one dose of study drug were included in the safety analysis | Posted | Count of Participants | Participants | No | 0 to 24h |
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| Secondary | Percentage of Subjects With Treatment Emergent AEs | AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment | all subjects who received at least one dose of study drug were included in the safety analysis | Posted | Number | percentage of participants | Day 69 (includes dosing Day 1, washout Day 12, safety follow up Day 69) |
|
0-69 days
AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
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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 | Glycopyrrolate Inhalation Solution12.5μg | Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution12.5μg: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily | 0 | 39 | 13 | 39 | ||
| EG001 | Glycopyrrolate Inhalation Solution 50μg | Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 50μg: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily | 0 | 38 | 9 | 38 | ||
| EG002 | Glycopyrrolate Inhalation Solution 100μg | Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily | 1 | 37 | 10 | 37 | ||
| EG003 | Glycopyrrolate Inhalation Solution 200μg | Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily | 0 | 37 | 10 | 37 | ||
| EG004 | Glycopyrrolate Inhalation Solution 400μg | Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily | 0 | 37 | 10 | 37 | ||
| EG005 | Placebo 0.5mL | Placebo 0.5mL via e-flow nebulizer, once daily Placebo 0.5mL: Placebo 0.5mL via eFlow, once daily | 0 | 37 | 10 | 37 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| groin pain | General disorders | MedDRA 13.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| skin injury | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| headache | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| cough | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
| |
| dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
In the event the Study is part of a multi-center study, the first publication of the results of the Study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following completion of the Study at all sites, Institution and Investigator shall be free to publish.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Respiratory Medical Director | Sunovion Pharmaceuticals Inc. | 1-866-503-6351 |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D004646 | Emphysema |
| D029481 | Bronchitis, Chronic |
| 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 |
| D001991 | Bronchitis |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D001982 | Bronchial Diseases |
Not provided
Not provided
| Protocol Violation |
|
| personal reasons |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| An analysis of covariance was used with change from baseline in trough FEV1 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. A sample size of 34 subjects (42 with dropouts) provides 80% power to detect a 0.14L difference in mean change trough FEV1 between 2 groups at an alpha of 0.05 using a 2-tailed t-test and assuming a common standard deviation for change in trough FEV1 of 0.2. | least squares mean | 0.0008 | least squares mean | 0.072 | 2-Sided | 95 | 0.030 | 0.113 | Superiority |
| An analysis of covariance was used with change from baseline in trough FEV1 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. A sample size of 34 subjects (42 with dropouts) provides 80% power to detect a 0.14L difference in mean change trough FEV1 between 2 groups at an alpha of 0.05 using a 2-tailed t-test and assuming a common standard deviation for change in trough FEV1 of 0.2. | least squares mean | <0.0001 | least squares mean | 0.102 | 2-Sided | 95 | 0.061 | 0.144 | Superiority |
| An analysis of covariance was used with change from baseline in trough FEV1 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. A sample size of 34 subjects (42 with dropouts) provides 80% power to detect a 0.14L difference in mean change trough FEV1 between 2 groups at an alpha of 0.05 using a 2-tailed t-test and assuming a common standard deviation for change in trough FEV1 of 0.2. | least squares mean | <0.0001 | least squares mean | 0.108 | 2-Sided | 95 | 0.066 | 0.150 | Superiority |
| An analysis of covariance was used with change from baseline in trough FEV1 as the response, with factors for center, treatment, period, sequence, baseline FEV1 as a covariate and a random effect for subject nested within sequence. A sample size of 34 subjects (42 with dropouts) provides 80% power to detect a 0.14L difference in mean change trough FEV1 between 2 groups at an alpha of 0.05 using a 2-tailed t-test and assuming a common standard deviation for change in trough FEV1 of 0.2. | least squares mean | <0.0001 | least squares mean | 0.098 | 2-Sided | 95 | 0.056 | 0.140 | Superiority |
Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily
Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily
| OG003 | Glycopyrrolate Inhalation Solution 200μg | Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily |
| OG004 | Glycopyrrolate Inhalation Solution 400μg | Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily |
| OG005 | Placebo 0.5mL | Placebo 0.5mL via e-flow nebulizer, once daily Placebo 0.5mL: Placebo 0.5mL via eFlow, once daily |
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Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily
Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily
| OG003 | Glycopyrrolate Inhalation Solution 200μg | Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily |
| OG004 | Glycopyrrolate Inhalation Solution 400μg | Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily |
| OG005 | Placebo 0.5mL | Placebo 0.5mL via e-flow nebulizer, once daily Placebo 0.5mL: Placebo 0.5mL via eFlow, once daily |
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Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily
Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily
| OG003 | Glycopyrrolate Inhalation Solution 200μg | Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily |
| OG004 | Glycopyrrolate Inhalation Solution 400μg | Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily |
| OG005 | Placebo 0.5mL | Placebo 0.5mL via e-flow nebulizer, once daily Placebo 0.5mL: Placebo 0.5mL via eFlow, once daily |
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| OG003 | Glycopyrrolate Inhalation Solution 200μg | Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily |
| OG004 | Glycopyrrolate Inhalation Solution 400μg | Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily |
| OG005 | Placebo 0.5mL | Placebo 0.5mL via e-flow nebulizer, once daily Placebo 0.5mL: Placebo 0.5mL via eFlow, once daily |
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| OG003 | Glycopyrrolate Inhalation Solution 200μg | Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily |
| OG004 | Glycopyrrolate Inhalation Solution 400μg | Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily |
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| OG003 | Glycopyrrolate Inhalation Solution 200μg | Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily |
| OG004 | Glycopyrrolate Inhalation Solution 400μg | Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily |
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| OG003 | Glycopyrrolate Inhalation Solution 200μg | Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily |
| OG004 | Glycopyrrolate Inhalation Solution 400μg | Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily |
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| OG003 | Glycopyrrolate Inhalation Solution 200μg | Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily |
| OG004 | Glycopyrrolate Inhalation Solution 400μg | Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily |
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| OG003 | Glycopyrrolate Inhalation Solution 200μg | Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily |
| OG004 | Glycopyrrolate Inhalation Solution 400μg | Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily |
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| OG003 | Glycopyrrolate Inhalation Solution 200μg | Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily |
| OG004 | Glycopyrrolate Inhalation Solution 400μg | Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily |
| OG005 | Placebo 0.5mL | Placebo 0.5mL via e-flow nebulizer, once daily Placebo 0.5mL: Placebo 0.5mL via eFlow, once daily |
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| OG003 | Glycopyrrolate Inhalation Solution 200μg | Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily |
| OG004 | Glycopyrrolate Inhalation Solution 400μg | Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily |
| OG005 | Placebo 0.5mL | Placebo 0.5mL via e-flow nebulizer, once daily Placebo 0.5mL: Placebo 0.5mL via eFlow, once daily |
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| OG003 | Glycopyrrolate Inhalation Solution 200μg | Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily |
| OG004 | Glycopyrrolate Inhalation Solution 400μg | Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily |
| OG005 | Placebo 0.5mL | Placebo 0.5mL via e-flow nebulizer, once daily Placebo 0.5mL: Placebo 0.5mL via eFlow, once daily |
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| OG003 | Glycopyrrolate Inhalation Solution 200μg | Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily |
| OG004 | Glycopyrrolate Inhalation Solution 400μg | Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily |
| OG005 | Placebo 0.5mL | Placebo 0.5mL via e-flow nebulizer, once daily Placebo 0.5mL: Placebo 0.5mL via eFlow, once daily |
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| OG003 |
| Glycopyrrolate Inhalation Solution 200μg |
Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily |
| OG004 | Glycopyrrolate Inhalation Solution 400μg | Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily |
| OG005 | Placebo 0.5mL | Placebo 0.5mL via e-flow nebulizer, once daily Placebo 0.5mL: Placebo 0.5mL via eFlow, once daily |
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