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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-010821-38 | EudraCT Number |
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The study assessed the safety and ability of several doses of an orally inhaled medicine [ie, Glycopyrrolate Inhalation Solution = GIS] to improve airflow in the lungs when delivered with an electronic eFlow nebulizer system in patients with Chronic Obstructive Pulmonary Disease (COPD). The study was conducted in 12 patients in 2 parts. Part 1 was designed to find the once-a- day GIS dose that produced the highest improvement in lung airflow. Part 2 tested the GIS dose with the highest improvement in lung airflow and a placebo (ie, no drug) delivered by a general purpose nebulizer. The airflow improvements of the same GIS dose were compared between the two nebulizer systems to determine what effect the device had on GIS delivery.
In Part I, 12 subjects were randomly allocated to one of 2 cohorts, running in parallel. The 6 cohort 1 subjects received 25 mg and then 200 mg during their treatment periods 1 and 2, respectively. The 6 cohort 2 subjects received 75mg, 500mg, and 1000 mg during their treatment periods 1, 2, and 3, respectively. During Part II of the study, the same 12 subjects from Part I were randomized to receive either 200 mg jet or placebo in a 1:1 ratio.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Glycopyrrolate Inhalation Solution 25mg | Experimental | Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily |
|
| Glycopyrrolate Inhalation Solution 75mg | Experimental | Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily |
|
| Glycopyrrolate Inhalation Solution 200mg | Experimental | Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily |
|
| Glycopyrrolate Inhalation Solution 200mg Jet | Experimental | Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily |
|
| Glycopyrrolate Inhalation Solution 500mg | Experimental | Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glycopyrrolate Inhalation Solution 25mg | Drug | 25 μg oral inhalation via eFlow Nebulizer, once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects Who Died | 0-47 days | |
| Number of Subjects With Treatment Emergent SAEs | AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment.AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment. SAEs are AEs that result in the following outcomes: death, are life-threatening, persistent or significant disability/incapacity, congenital anomaly/birth defect, or important medical events that may have been considered a SAE when, based upon appropriate medical judgment, they may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed in the definition. | 0-47 days |
| Number of Subjects Who Discontinued Due to AE | AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment. | 0-47 days |
| Percentage of Subjects With Treatment Emergent AEs | AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment. | 0-47 days |
| Number of Subjects With Clinically Significant Abnormal Vital Signs Reported During the Study | Vital signs were measured at screening, during the study (pre-dose, and 30 and 60 minutes and 2, 4, 8, 12, 24 and 30 hours post-dose) and at post study assessment. The clinical significance of each out of normal range vital sign parameter was determined by the investigator during the study. | 30 hrs post dose |
| Number of Subjects With Clinically Significant Abnormal Laboratory Results Reported During the Study |
| 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 spirometry value collected at 24 hours post dose within each Treatment Period. | 24hr post dose |
| Peak FEV1 (Percent Change) |
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Inclusion Criteria:
Male and female patients aged 40 through 75 years, inclusive
A clinical diagnosis of COPD according to the GOLD guidelines
Current smokers or ex-smokers with at least 10 pack-year smoking history (e.g., at least 1 pack/day for 10 years, or 10 packs/day for 1 year)
Post-bronchodilator FEV1 40-80% of predicted normal
Post-bronchodilator FEV1/FVC ratio < 0.70
Improvement in FEV1 >12% (minimum 150 mL) following inhalation of ipratropium bromide
Ability to perform reproducible spirometry according to the ATS/ERS guidelines
If female and of childbearing potential, must have had a negative pregnancy test and was not lactating at the Screening Visit, and was using one of the following acceptable means of birth control throughout the study:
Willing and able to provide written informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ahmet Tutuncu, MD, PhD | Elevation Pharmaceuticals, Inc.(now known as Sunovion Respiratory Development Inc.) | Study Chair |
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| ID | Title | Description |
|---|---|---|
| FG000 | 25mg Glycopyrrolate, 200mg Gloycopyrrolate | subjects received 25mg Glycopyrrolate then 200mg Glycopyrrolate in part 1- in part 2 subjects from this group either received 200mg Glycopyrrolate or placebo |
| FG001 | 75mg Glycopyrrolate,500mg Glycopyrrolate,1000mg Glycopyrrolate |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Study Part 1 |
|
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| Glycopyrrolate Inhalation Solution1000mg |
| Experimental |
Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily |
|
| Placebo 0.5 mL | Placebo Comparator | Placebo 0.5 mL via jet nebulizer, once daily |
|
| Glycopyrrolate Inhalation Solution 75mg | Drug | 75 μg oral inhalation via eFlow Nebulizer, once daily |
|
|
| Glycopyrrolate Inhalation Solution 200mg | Drug | 200 μg oral inhalation via eFlow Nebulizer, once daily |
|
|
| Glycopyrrolate Inhalation Solution 200mg Jet | Drug | 200 μg oral inhalation via inhalation via jet nebulizer, once daily |
|
|
| Glycopyrrolate Inhalation Solution 500mg | Drug | 500 μg oral inhalation via eFlow nebulizer, once daily |
|
|
| Glycopyrrolate Inhalation Solution1000mg | Drug | 1000 μg oral inhalation via eFlow nebulizer, once daily |
|
|
| Placebo | Drug | Placebo 0.5 mL oral inhalation via jet nebulizer, once daily |
|
Clinical safety lab parameters were collected at screening and at the post study follow-up assessment. The clinical significance of each out of normal range laboratory parameter was determined by the investigator during the study. |
| day 47 (post studyfollow-up assessment) |
| Number of Subjects With Clinically Significant ECG Parameters Reported During the Study | ECGs were measured at screening, during the study (pre-dose, and 30 and 60 minutes and 2, 4, 8, 12, 24 and 30 hours post-dose) and at post study follow-up assessment. | 30hr post dose |
| Number of Subjects With Clinically Significant Abnormal Laboratory Results Reported During the Study | Clinical safety lab parameters were collected at screening and at the post study follow-up assessment. The clinical significance of each out of normal range laboratory parameter was determined by the investigator during the study. | post study follow-up assessment (Day 47) |
| Number of Subjects With Treatment Emergent AEs | AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment. SAEs are AEs that result in the following outcomes: death, are life-threatening, persistent or significant disability/incapacity, congenital anomaly/birth defect, or important medical events that may have been considered a SAE when, based upon appropriate medical judgment, they may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed in the definition. | 0-47 days |
Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. |
| 0 to 4hr |
| Peak FEV1 (Change From Baseline ) | Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. | 0 to 4hr |
| FEV1 AUC0-24 Area Under the FEV1 Over Time Curve (Change From Baseline) | Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. | 0 to 24hr post dose |
| 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 hours post dose |
| 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 | 0 to 12 hours post dose |
| AUC0-t Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration | Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr | 0 to 12 hourr post dose |
| 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 hours post dose |
| 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 hours post-dose |
subjects received 75mg Glycoprrolate, then, 500mg Glycopyrrolate, then 1000mg Glycopyrrolate in part 1 - in part 2 subjects from this group received either 200mg Glycopyrrolate or placebo |
| FG002 | 200mg Glycopyrrolate Jet | subjects received 200mg Glycopyrrolate |
| FG003 | Placebo | Subjects received placebo |
| COMPLETED |
|
| NOT COMPLETED |
|
| Study Part 2 |
|
All participants in study
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| ID | Title | Description |
|---|---|---|
| BG000 | 25mg Glycopyrrolate, 200mg Gloycopyrrolate | subjects received 25mg Glycopyrrolate then 200mg Glycopyrrolate in part 1- in part 2 subjects from this group either received 200mg Glycopyrrolate or placebo |
| BG001 | 75mg Glycopyrrolate,500mg Glycopyrrolate,1000mg Glycopyrrolate | subjects received 75mg Glycoprrolate, then, 500mg Glycopyrrolate, then 1000mg Glycopyrrolate in part 1 - in part 2 subjects from this group received either 200mg Glycopyrrolate or placebo |
| BG002 | 200mg Glycopyrrolate Jet | subjects received 200mg Glycopyrrolate |
| BG003 | Placebo | subjects received placebo |
| BG004 | 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, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | 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 | Number of Subjects Who Died | all subjects who received at least one dose of study medication were included in the safety analysis.. A subject received more than one treatment type throughout the study. | Posted | Count of Participants | Participants | No | 0-47 days |
|
|
| ||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Subjects With Treatment Emergent SAEs | AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment.AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment. SAEs are AEs that result in the following outcomes: death, are life-threatening, persistent or significant disability/incapacity, congenital anomaly/birth defect, or important medical events that may have been considered a SAE when, based upon appropriate medical judgment, they may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed in the definition. | all subjects who received at least one dose of study medication were included in the safety analysis.. A subject received more than one treatment type throughout the study. | Posted | Count of Participants | Participants | No | 0-47 days |
| |||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Subjects Who Discontinued Due to AE | AEs 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 medication were included in the safety analysis. . A subject received more than one treatment type throughout the study. | Posted | Count of Participants | Participants | No | 0-47 days |
| |||||||||||||||||||||||||||||||||||||||||||||
| Primary | Percentage of Subjects With Treatment Emergent AEs | AEs 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 medication were included in the safety analysis. . A subject received more than one treatment type throughout the study. | Posted | Number | percentage of participants | 0-47 days |
| ||||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Subjects With Clinically Significant Abnormal Vital Signs Reported During the Study | Vital signs were measured at screening, during the study (pre-dose, and 30 and 60 minutes and 2, 4, 8, 12, 24 and 30 hours post-dose) and at post study assessment. The clinical significance of each out of normal range vital sign parameter was determined by the investigator during the study. | all subjects who received at least one dose of study medication were included in the safety analysis. . A subject received more than one treatment type throughout the study. | Posted | Count of Participants | Participants | No | 30 hrs post dose |
| |||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Subjects With Clinically Significant Abnormal Laboratory Results Reported During the Study | Clinical safety lab parameters were collected at screening and at the post study follow-up assessment. The clinical significance of each out of normal range laboratory parameter was determined by the investigator during the study. | all subjects who received at least one dose of study medication were included in the safety analysis. A subject received more than one treatment type throughout the study. | Posted | Count of Participants | Participants | No | day 47 (post studyfollow-up assessment) |
| |||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Subjects With Clinically Significant ECG Parameters Reported During the Study | ECGs were measured at screening, during the study (pre-dose, and 30 and 60 minutes and 2, 4, 8, 12, 24 and 30 hours post-dose) and at post study follow-up assessment. | all subjects who received at least one dose of study medication were included in the safety analysis. A subject received more than one treatment type throughout the study | Posted | Count of Participants | Participants | No | 30hr post dose |
| |||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Subjects With Clinically Significant Abnormal Laboratory Results Reported During the Study | Clinical safety lab parameters were collected at screening and at the post study follow-up assessment. The clinical significance of each out of normal range laboratory parameter was determined by the investigator during the study. | all subjects who received at least one dose of study medication were included in the safety analysis. A subject received more than one treatment type throughout the study. | Posted | Count of Participants | Participants | No | post study follow-up assessment (Day 47) |
| |||||||||||||||||||||||||||||||||||||||||||||
| Primary | Number of Subjects With Treatment Emergent AEs | AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment. SAEs are AEs that result in the following outcomes: death, are life-threatening, persistent or significant disability/incapacity, congenital anomaly/birth defect, or important medical events that may have been considered a SAE when, based upon appropriate medical judgment, they may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed in the definition. | all subjects who received at least one dose of study medication were included in the safety analysis. A subject received more than one treatment type throughout the study | Posted | Count of Participants | Participants | No | 0-47 days |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Trough FEV1 (Change From Baseline) | Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. Trough FEV1 was defined as the spirometry value collected at 24 hours post dose within each Treatment Period. | 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. A subject received more than one treatment type throughout the study. | Posted | Mean | Standard Deviation | liters | 24hr post dose |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Peak FEV1 (Percent Change) | Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. | all subjects who received at least one dose of the study medication and have at least one post baseline efficacy measurement were included in the efficacy population. . A subject received more than one treatment type throughout the study. | Posted | Mean | Standard Deviation | percent change | 0 to 4hr |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Peak FEV1 (Change From Baseline ) | Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. | 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.. A subject received more than one treatment type throughout the study. | Posted | Mean | Standard Deviation | liters | 0 to 4hr |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | FEV1 AUC0-24 Area Under the FEV1 Over Time Curve (Change From Baseline) | Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. | All subjects who received at least one dose of study medication and have at least one post baselineefficacy measurement were included in the efficacy population. A subject received more than one treatment type throughout the study. | Posted | Mean | Standard Deviation | liters | 0 to 24hr post dose |
| |||||||||||||||||||||||||||||||||||||||||||||
| 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 study medication and who have sufficient blood samples taken to obtain a plasma concentration by time profile were included in the PK . A subject received more than one treatment type throughout the study. analysis. | Posted | Mean | Standard Deviation | pg/mL | 0 to 12 hours post dose |
| |||||||||||||||||||||||||||||||||||||||||||||
| 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 study medication and who have sufficient blood samples taken to obtain a plasma concentration by time profile were included in the PK analysis. A subject received more than one treatment type throughout the study. | Posted | Mean | Standard Deviation | hours | 0 to 12 hours post dose |
| |||||||||||||||||||||||||||||||||||||||||||||
| Secondary | AUC0-t Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable 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 study medication and who have sufficient blood samples taken to obtain a plasma concentration by time profile were included in the PK analysis.A subject received more than one treatment type throughout the study. | Posted | Mean | Standard Deviation | pg*h/mL | 0 to 12 hourr post dose |
| |||||||||||||||||||||||||||||||||||||||||||||
| 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 study medication and who have sufficient blood samples taken to obtain a plasma concentration by time profile were included in the PK analysis. A subject received more than one treatment type throughout the study. | Posted | Mean | Standard Deviation | pg*h/mL | 0 to 12 hours post dose |
| |||||||||||||||||||||||||||||||||||||||||||||
| 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. | Subjects who received at least one dose of study medication and have sufficient blood samples taken to obtain a plasma concentration by time profile were included in the PK analysis.Subject received more than one treatment type throughout the study samples taken to obtain a plasma concentration by time profile were included in the PK analysis. | Posted | Mean | Standard Deviation | hour | 0 to 12 hours post-dose |
|
0-47 days
AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
Not provided
| 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 Solution 25 μg | Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily Glycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily | 0 | 6 | 2 | 6 | ||
| EG001 | Glycopyrrolate Inhalation Solution75μg | Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily | 0 | 6 | 2 | 6 | ||
| EG002 | Glycopyrrolate Inhalation Solution 200 μg | Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily | 0 | 6 | 4 | 6 | ||
| EG003 | Glycopyrrolate Inhalation Solution 200μg Jet Nebulizer, | Glycopyrrolate Inhalation Solution 200μg Jet Nebulizer ,once daily Glycopyrrolate Inhalation Solution 200μg Jet Nebulizer, once daily | 0 | 6 | 2 | 6 | ||
| EG004 | Glycopyrrolate Inhalation Solution 500μg | Glycopyrrolate Inhalation Solution 500μg eFlow Nebulizer, once daily Glycopyrrolate Inhalation Solution 500μg eFlow Nebulizer, once daily | 0 | 6 | 0 | 6 | ||
| EG005 | Glycopyrrolate Inhalation Solution1000mg | Glycopyrrolate Inhalation Solution1000mg via eFlow nebulizer, once daily Glycopyrrolate Inhalation Solution1000mg via eFlow nebulizer, once daily | 0 | 6 | 2 | 6 | ||
| EG006 | Placebo | Placebo Placebo | 0 | 6 | 1 | 6 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| catheter site related reaction | General disorders | MedDRA (11.0) | Systematic Assessment |
| |
| nasopharyngitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| rhinitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| headache | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
| |
| cough | Respiratory, thoracic and mediastinal disorders | MedDRA (11.0) | 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
| >=65 years |
|
| Male |
|
| OG002 | Glycopyrrolate Inhalation Solution 200mg | Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily |
| OG003 | Glycopyrrolate Inhalation Solution 200mg Jet | Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily Glycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily |
| OG004 | Glycopyrrolate Inhalation Solution 500mg | Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily |
| OG005 | Glycopyrrolate Inhalation Solution1000mg | Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily |
| OG006 | Placebo 0.5 mL | Placebo 0.5 mL via jet nebulizer, once daily Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily |
|
|
| Glycopyrrolate Inhalation Solution 200mg Jet |
Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily Glycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily |
| OG004 | Glycopyrrolate Inhalation Solution 500mg | Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily |
| OG005 | Glycopyrrolate Inhalation Solution1000mg | Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily |
| OG006 | Placebo 0.5 mL | Placebo 0.5 mL via jet nebulizer, once daily Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily |
|
|
| Glycopyrrolate Inhalation Solution 200mg Jet |
Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily Glycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily |
| OG004 | Glycopyrrolate Inhalation Solution 500mg | Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily |
| OG005 | Glycopyrrolate Inhalation Solution1000mg | Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily |
| OG006 | Placebo 0.5 mL | Placebo 0.5 mL via jet nebulizer, once daily Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily |
|
|
| OG003 | Glycopyrrolate Inhalation Solution 200mg Jet | Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily Glycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily |
| OG004 | Glycopyrrolate Inhalation Solution 500mg | Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily |
| OG005 | Glycopyrrolate Inhalation Solution1000mg | Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily |
| OG006 | Placebo 0.5 mL | Placebo 0.5 mL via jet nebulizer, once daily Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily |
|
|
| OG003 | Glycopyrrolate Inhalation Solution 200mg Jet | Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily Glycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily |
| OG004 | Glycopyrrolate Inhalation Solution 500mg | Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily |
| OG005 | Glycopyrrolate Inhalation Solution1000mg | Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily |
| OG006 | Placebo 0.5 mL | Placebo 0.5 mL via jet nebulizer, once daily Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily |
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| OG003 | Glycopyrrolate Inhalation Solution 200mg Jet | Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily Glycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily |
| OG004 | Glycopyrrolate Inhalation Solution 500mg | Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily |
| OG005 | Glycopyrrolate Inhalation Solution1000mg | Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily |
| OG006 | Placebo 0.5 mL | Placebo 0.5 mL via jet nebulizer, once daily Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily |
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| OG003 | Glycopyrrolate Inhalation Solution 200mg Jet | Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily Glycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily |
| OG004 | Glycopyrrolate Inhalation Solution 500mg | Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily |
| OG005 | Glycopyrrolate Inhalation Solution1000mg | Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily |
| OG006 | Placebo 0.5 mL | Placebo 0.5 mL via jet nebulizer, once daily Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily |
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Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily |
| OG003 | Glycopyrrolate Inhalation Solution 200mg Jet | Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily Glycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily |
| OG004 | Glycopyrrolate Inhalation Solution 500mg | Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily |
| OG005 | Glycopyrrolate Inhalation Solution1000mg | Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily |
| OG006 | Placebo 0.5 mL | Placebo 0.5 mL via jet nebulizer, once daily Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily |
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| OG003 | Glycopyrrolate Inhalation Solution 200mg Jet | Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily Glycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily |
| OG004 | Glycopyrrolate Inhalation Solution 500mg | Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily |
| OG005 | Glycopyrrolate Inhalation Solution1000mg | Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily |
| OG006 | Placebo 0.5 mL | Placebo 0.5 mL via jet nebulizer, once daily Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily |
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| OG003 |
| Glycopyrrolate Inhalation Solution 200mg Jet |
Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily Glycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily |
| OG004 | Glycopyrrolate Inhalation Solution 500mg | Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily |
| OG005 | Glycopyrrolate Inhalation Solution1000mg | Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily |
| OG006 | Placebo 0.5 mL | Placebo 0.5 mL via jet nebulizer, once daily Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily |
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| Glycopyrrolate Inhalation Solution 200mg Jet |
Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily Glycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily |
| OG004 | Glycopyrrolate Inhalation Solution 500mg | Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily |
| OG005 | Glycopyrrolate Inhalation Solution1000mg | Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily |
| OG006 | Placebo 0.5 mL | Placebo 0.5 mL via jet nebulizer, once daily Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily |
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| OG003 | Glycopyrrolate Inhalation Solution 200mg Jet | Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily Glycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily |
| OG004 | Glycopyrrolate Inhalation Solution 500mg | Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily |
| OG005 | Glycopyrrolate Inhalation Solution1000mg | Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily |
| OG006 | Placebo 0.5 mL | Placebo 0.5 mL via jet nebulizer, once daily Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily |
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| OG003 | Glycopyrrolate Inhalation Solution1000mg | Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily |
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| OG003 | Glycopyrrolate Inhalation Solution1000mg | Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily |
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| OG003 | Glycopyrrolate Inhalation Solution1000mg | Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily |
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| OG003 | Glycopyrrolate Inhalation Solution1000mg | Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily |
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| OG003 | Glycopyrrolate Inhalation Solution1000mg | Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily |
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