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Trial record 20 of 186 for:    GLYCOPYRROLATE

Assessment of the Safety and Ability of a Once-a-day Dose 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 safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02951312
Recruitment Status : Completed
First Posted : November 1, 2016
Results First Posted : April 30, 2018
Last Update Posted : April 30, 2018
Sponsor:
Information provided by (Responsible Party):
Sunovion Respiratory Development Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Outcomes Assessor);   Primary Purpose: Treatment
Condition Chronic Obstructive Pulmonary Disease
Interventions Drug: Glycopyrrolate Inhalation Solution 25mg
Drug: Glycopyrrolate Inhalation Solution 75mg
Drug: Glycopyrrolate Inhalation Solution 200mg
Drug: Glycopyrrolate Inhalation Solution 200mg Jet
Drug: Glycopyrrolate Inhalation Solution 500mg
Drug: Glycopyrrolate Inhalation Solution1000mg
Drug: Placebo
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 25mg Glycopyrrolate, 200mg Gloycopyrrolate 75mg Glycopyrrolate,500mg Glycopyrrolate,1000mg Glycopyrrolate 200mg Glycopyrrolate Jet Placebo
Hide Arm/Group Description subjects received 25mg Glycopyrrolate then 200mg Glycopyrrolate in part 1- in part 2 subjects from this group either received 200mg Glycopyrrolate or placebo 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 subjects received 200mg Glycopyrrolate Subjects received placebo
Period Title: Study Part 1
Started 6 6 0 0
Completed 6 6 0 0
Not Completed 0 0 0 0
Period Title: Study Part 2
Started 0 0 6 6
Completed 0 0 6 6
Not Completed 0 0 0 0
Arm/Group Title 25mg Glycopyrrolate, 200mg Gloycopyrrolate 75mg Glycopyrrolate,500mg Glycopyrrolate,1000mg Glycopyrrolate 200mg Glycopyrrolate Jet Placebo Total
Hide Arm/Group Description subjects received 25mg Glycopyrrolate then 200mg Glycopyrrolate in part 1- in part 2 subjects from this group either received 200mg Glycopyrrolate or placebo 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 subjects received 200mg Glycopyrrolate subjects received placebo Total of all reporting groups
Overall Number of Baseline Participants 6 6 0 0 12
Hide Baseline Analysis Population Description
All participants in study
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 0 participants 0 participants 12 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
  33.3%
3
  50.0%
5
  41.7%
>=65 years
4
  66.7%
3
  50.0%
7
  58.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 0 participants 0 participants 12 participants
66.2  (3.82) 63.5  (8.89) 41.67  (58.33)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 0 participants 0 participants 12 participants
Female
3
  50.0%
2
  33.3%
5
  41.7%
Male
3
  50.0%
4
  66.7%
7
  58.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United Kingdom Number Analyzed 6 participants 6 participants 0 participants 0 participants 12 participants
6 6 12
1.Primary Outcome
Title Number of Subjects Who Died
Hide Description [Not Specified]
Time Frame 0-47 days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Glycopyrrolate Inhalation Solution 25mg Glycopyrrolate Inhalation Solution 75mg Glycopyrrolate Inhalation Solution 200mg Glycopyrrolate Inhalation Solution 200mg Jet Glycopyrrolate Inhalation Solution 500mg Glycopyrrolate Inhalation Solution1000mg Placebo 0.5 mL
Hide Arm/Group Description:

Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily

Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily

Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily

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

Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily

Placebo 0.5 mL via jet nebulizer, once daily

Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily

Overall Number of Participants Analyzed 6 6 6 6 6 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
0 0 0 0 0 0 0
2.Primary Outcome
Title Number of Subjects With Treatment Emergent SAEs
Hide Description 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.
Time Frame 0-47 days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Glycopyrrolate Inhalation Solution 25mg Glycopyrrolate Inhalation Solution 75mg Glycopyrrolate Inhalation Solution 200mg Glycopyrrolate Inhalation Solution 200mg Jet Glycopyrrolate Inhalation Solution 500mg Glycopyrrolate Inhalation Solution1000mg Placebo 0.5 mL
Hide Arm/Group Description:

Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily

Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily

Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily

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

Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily

Placebo 0.5 mL via jet nebulizer, once daily

Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily

Overall Number of Participants Analyzed 6 6 6 6 6 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
0 0 0 0 0 0 0
3.Primary Outcome
Title Number of Subjects Who Discontinued Due to AE
Hide Description AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment.
Time Frame 0-47 days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Glycopyrrolate Inhalation Solution 25mg Glycopyrrolate Inhalation Solution 75mg Glycopyrrolate Inhalation Solution 200mg Glycopyrrolate Inhalation Solution 200mg Jet Glycopyrrolate Inhalation Solution 500mg Glycopyrrolate Inhalation Solution1000mg Placebo 0.5 mL
Hide Arm/Group Description:

Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily

Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily

Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily

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

Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily

Placebo 0.5 mL via jet nebulizer, once daily

Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily

Overall Number of Participants Analyzed 6 6 6 6 6 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
0 0 0 0 0 0 0
4.Primary Outcome
Title Percentage of Subjects With Treatment Emergent AEs
Hide Description AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment.
Time Frame 0-47 days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Glycopyrrolate Inhalation Solution 25mg Glycopyrrolate Inhalation Solution 75mg Glycopyrrolate Inhalation Solution 200mg Glycopyrrolate Inhalation Solution 200mg Jet Glycopyrrolate Inhalation Solution 500mg Glycopyrrolate Inhalation Solution1000mg Placebo 0.5 mL
Hide Arm/Group Description:

Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily

Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily

Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily

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

Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily

Placebo 0.5 mL via jet nebulizer, once daily

Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily

Overall Number of Participants Analyzed 6 6 6 6 6 6 6
Measure Type: Number
Unit of Measure: percentage of participants
33.3 33.3 66.7 33.3 0.0 33.3 16.7
5.Primary Outcome
Title Number of Subjects With Clinically Significant Abnormal Vital Signs Reported During the Study
Hide Description 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.
Time Frame 30 hrs post dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Glycopyrrolate Inhalation Solution 25mg Glycopyrrolate Inhalation Solution 75mg Glycopyrrolate Inhalation Solution 200mg Glycopyrrolate Inhalation Solution 200mg Jet Glycopyrrolate Inhalation Solution 500mg Glycopyrrolate Inhalation Solution1000mg Placebo 0.5 mL
Hide Arm/Group Description:

Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily

Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily

Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily

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

Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily

Placebo 0.5 mL via jet nebulizer, once daily

Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily

Overall Number of Participants Analyzed 6 6 6 6 6 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
0 0 0 0 0 0 0
6.Primary Outcome
Title Number of Subjects With Clinically Significant Abnormal Laboratory Results Reported During the Study
Hide Description 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.
Time Frame day 47 (post studyfollow-up assessment)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Glycopyrrolate Inhalation Solution 25mg Glycopyrrolate Inhalation Solution 75mg Glycopyrrolate Inhalation Solution 200mg Glycopyrrolate Inhalation Solution 200mg Jet Glycopyrrolate Inhalation Solution 500mg Glycopyrrolate Inhalation Solution1000mg Placebo 0.5 mL
Hide Arm/Group Description:

Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily

Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily

Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily

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

Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily

Placebo 0.5 mL via jet nebulizer, once daily

Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily

Overall Number of Participants Analyzed 6 6 6 6 6 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
0 0 0 0 0 0 0
7.Primary Outcome
Title Number of Subjects With Clinically Significant ECG Parameters Reported During the Study
Hide Description 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.
Time Frame 30hr post dose
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Glycopyrrolate Inhalation Solution 25mg Glycopyrrolate Inhalation Solution 75mg Glycopyrrolate Inhalation Solution 200mg Glycopyrrolate Inhalation Solution 200mg Jet Glycopyrrolate Inhalation Solution 500mg Glycopyrrolate Inhalation Solution1000mg Placebo 0.5 mL
Hide Arm/Group Description:

Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily

Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily

Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily

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

Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily

Placebo 0.5 mL via jet nebulizer, once daily

Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily

Overall Number of Participants Analyzed 6 6 6 6 6 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
0 0 0 0 0 0 0
8.Primary Outcome
Title Number of Subjects With Clinically Significant Abnormal Laboratory Results Reported During the Study
Hide Description 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.
Time Frame post study follow-up assessment (Day 47)
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Glycopyrrolate Inhalation Solution 25mg Glycopyrrolate Inhalation Solution 75mg Glycopyrrolate Inhalation Solution 200mg Glycopyrrolate Inhalation Solution 200mg Jet Glycopyrrolate Inhalation Solution 500mg Glycopyrrolate Inhalation Solution1000mg Placebo 0.5 mL
Hide Arm/Group Description:

Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily

Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily

Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily

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

Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily

Placebo 0.5 mL via jet nebulizer, once daily

Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily

Overall Number of Participants Analyzed 6 6 6 6 6 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
0 0 0 0 0 0 0
9.Primary Outcome
Title Number of Subjects With Treatment Emergent AEs
Hide Description 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.
Time Frame 0-47 days
Hide Outcome Measure Data
Hide Analysis Population Description
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
Arm/Group Title Glycopyrrolate Inhalation Solution 25mg Glycopyrrolate Inhalation Solution 75mg Glycopyrrolate Inhalation Solution 200mg Glycopyrrolate Inhalation Solution 200mg Jet Glycopyrrolate Inhalation Solution 500mg Glycopyrrolate Inhalation Solution1000mg Placebo 0.5 mL
Hide Arm/Group Description:

Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily

Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily

Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily

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

Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily

Placebo 0.5 mL via jet nebulizer, once daily

Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily

Overall Number of Participants Analyzed 6 6 6 6 6 6 6
Measure Type: Count of Participants
Unit of Measure: Participants
2 2 4 2 0 2 1
10.Secondary Outcome
Title Trough FEV1 (Change From Baseline)
Hide Description 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.
Time Frame 24hr post dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Glycopyrrolate Inhalation Solution 25mg Glycopyrrolate Inhalation Solution 75mg Glycopyrrolate Inhalation Solution 200mg Glycopyrrolate Inhalation Solution 200mg Jet Glycopyrrolate Inhalation Solution 500mg Glycopyrrolate Inhalation Solution1000mg Placebo 0.5 mL
Hide Arm/Group Description:

Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily

Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily

Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily

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

Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily

Placebo 0.5 mL via jet nebulizer, once daily

Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily

Overall Number of Participants Analyzed 6 6 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: liters
0.038  (0.157) 0.087  (0.062) 0.138  (0.079) -0.013  (0.098) -0.017  (0.168) 0.065  (0.072) -0.030  (0.070)
11.Secondary Outcome
Title Peak FEV1 (Percent Change)
Hide Description Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.
Time Frame 0 to 4hr
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Glycopyrrolate Inhalation Solution 25mg Glycopyrrolate Inhalation Solution 75mg Glycopyrrolate Inhalation Solution 200mg Glycopyrrolate Inhalation Solution 200mg Jet Glycopyrrolate Inhalation Solution 500mg Glycopyrrolate Inhalation Solution1000mg Placebo 0.5 mL
Hide Arm/Group Description:

Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily

Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily

Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily

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

Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily

Placebo 0.5 mL via jet nebulizer, once daily

Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily

Overall Number of Participants Analyzed 6 6 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: percent change
17.12  (9.07) 15.60  (4.20) 22.98  (4.99) 19.28  (13.10) 11.47  (6.86) 16.87  (6.83) 6.80  (2.91)
12.Secondary Outcome
Title Peak FEV1 (Change From Baseline )
Hide Description Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.
Time Frame 0 to 4hr
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Glycopyrrolate Inhalation Solution 25mg Glycopyrrolate Inhalation Solution 75mg Glycopyrrolate Inhalation Solution 200mg Glycopyrrolate Inhalation Solution 200mg Jet Glycopyrrolate Inhalation Solution 500mg Glycopyrrolate Inhalation Solution1000mg Placebo 0.5 mL
Hide Arm/Group Description:

Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily

Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily

Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily

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

Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily

Placebo 0.5 mL via jet nebulizer, once daily

Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily

Overall Number of Participants Analyzed 6 6 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: liters
0.212  (0.086) 0.255  (0.068) 0.303  (0.055) 0.233  (0.144) 0.177  (0.061) 0.283  (0.069) 0.120  (0.057)
13.Secondary Outcome
Title FEV1 AUC0-24 Area Under the FEV1 Over Time Curve (Change From Baseline)
Hide Description Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.
Time Frame 0 to 24hr post dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Glycopyrrolate Inhalation Solution 25mg Glycopyrrolate Inhalation Solution 75mg Glycopyrrolate Inhalation Solution 200mg Glycopyrrolate Inhalation Solution 200mg Jet Glycopyrrolate Inhalation Solution 500mg Glycopyrrolate Inhalation Solution1000mg Placebo 0.5 mL
Hide Arm/Group Description:

Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily

Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily

Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily

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

Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily

Placebo 0.5 mL via jet nebulizer, once daily

Placebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily

Overall Number of Participants Analyzed 6 6 6 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: liters
1.59  (3.27) 3.10  (2.27) 3.19  (1.14) 1.35  (2.74) 1.53  (2.05) 3.08  (1.47) -0.11  (1.89)
14.Secondary Outcome
Title Cmax Maximum Observed Plasma Concentration
Hide Description Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr
Time Frame 0 to 12 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Glycopyrrolate Inhalation Solution 200mg Glycopyrrolate Inhalation Solution 200mg Jet Glycopyrrolate Inhalation Solution 500mg Glycopyrrolate Inhalation Solution1000mg
Hide Arm/Group Description:

Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily

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

Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily

Overall Number of Participants Analyzed 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: pg/mL
177.242  (61.469) 75.530  (64.950) 749.872  (219.696) 1534.057  (442.581)
15.Secondary Outcome
Title Tmax Time to Maximum Observed Plasma Concentration
Hide Description Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr
Time Frame 0 to 12 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Glycopyrrolate Inhalation Solution 200mg Glycopyrrolate Inhalation Solution 200mg Jet Glycopyrrolate Inhalation Solution 500mg Glycopyrrolate Inhalation Solution1000mg
Hide Arm/Group Description:

Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily

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

Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily

Overall Number of Participants Analyzed 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: hours
.025  (0.088) 0.08  (0.088) 0.25  (0.069) 0.17  (0.093)
16.Secondary Outcome
Title AUC0-t Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration
Hide Description Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr
Time Frame 0 to 12 hourr post dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Glycopyrrolate Inhalation Solution 200mg Glycopyrrolate Inhalation Solution 200mg Jet Glycopyrrolate Inhalation Solution 500mg Glycopyrrolate Inhalation Solution1000mg
Hide Arm/Group Description:

Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily

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

Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily

Overall Number of Participants Analyzed 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: pg*h/mL
429.335  (192.699) 26.176  (16.170) 2014.276  (609.911) 4084.763  (827.225)
17.Secondary Outcome
Title AUC0-inf Area Under the Plasma Concentration-time Curve From Time Zero to Infinity
Hide Description Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr
Time Frame 0 to 12 hours post dose
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Glycopyrrolate Inhalation Solution 200mg Glycopyrrolate Inhalation Solution 200mg Jet Glycopyrrolate Inhalation Solution 500mg Glycopyrrolate Inhalation Solution1000mg
Hide Arm/Group Description:

Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily

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

Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily

Overall Number of Participants Analyzed 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: pg*h/mL
563.416  (235.418) 65.013  (16.750) 2491.803  (736.426) 5271.099  (1096.862)
18.Secondary Outcome
Title t1/2 Plasma Half-life
Hide Description Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr.
Time Frame 0 to 12 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description

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.

Arm/Group Title Glycopyrrolate Inhalation Solution 200mg Glycopyrrolate Inhalation Solution 200mg Jet Glycopyrrolate Inhalation Solution 500mg Glycopyrrolate Inhalation Solution1000mg
Hide Arm/Group Description:

Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily

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

Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily

Overall Number of Participants Analyzed 6 6 6 6
Mean (Standard Deviation)
Unit of Measure: hour
2.947  (1.996) 0.778  (0.465) 6.298  (1.450) 7.573  (1.031)
Time Frame 0-47 days
Adverse Event Reporting Description AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
 
Arm/Group Title Glycopyrrolate Inhalation Solution 25 μg Glycopyrrolate Inhalation Solution75μg Glycopyrrolate Inhalation Solution 200 μg Glycopyrrolate Inhalation Solution 200μg Jet Nebulizer, Glycopyrrolate Inhalation Solution 500μg Glycopyrrolate Inhalation Solution1000mg Placebo
Hide Arm/Group Description

Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily

Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution 200μg Jet Nebulizer ,once daily

Glycopyrrolate Inhalation Solution 200μg Jet Nebulizer, once daily

Glycopyrrolate Inhalation Solution 500μg eFlow Nebulizer, once daily

Glycopyrrolate Inhalation Solution 500μg eFlow Nebulizer, once daily

Glycopyrrolate Inhalation Solution1000mg via eFlow nebulizer, once daily

Glycopyrrolate Inhalation Solution1000mg via eFlow nebulizer, once daily

Placebo

Placebo

All-Cause Mortality
Glycopyrrolate Inhalation Solution 25 μg Glycopyrrolate Inhalation Solution75μg Glycopyrrolate Inhalation Solution 200 μg Glycopyrrolate Inhalation Solution 200μg Jet Nebulizer, Glycopyrrolate Inhalation Solution 500μg Glycopyrrolate Inhalation Solution1000mg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Glycopyrrolate Inhalation Solution 25 μg Glycopyrrolate Inhalation Solution75μg Glycopyrrolate Inhalation Solution 200 μg Glycopyrrolate Inhalation Solution 200μg Jet Nebulizer, Glycopyrrolate Inhalation Solution 500μg Glycopyrrolate Inhalation Solution1000mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)      0/6 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Glycopyrrolate Inhalation Solution 25 μg Glycopyrrolate Inhalation Solution75μg Glycopyrrolate Inhalation Solution 200 μg Glycopyrrolate Inhalation Solution 200μg Jet Nebulizer, Glycopyrrolate Inhalation Solution 500μg Glycopyrrolate Inhalation Solution1000mg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/6 (33.33%)      2/6 (33.33%)      4/6 (66.67%)      2/6 (33.33%)      0/6 (0.00%)      2/6 (33.33%)      1/6 (16.67%)    
General disorders               
catheter site related reaction  1  1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 2/6 (33.33%)  4 0/6 (0.00%)  0 2/6 (33.33%)  2 1/6 (16.67%)  1
Infections and infestations               
nasopharyngitis  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
rhinitis  1  0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Musculoskeletal and connective tissue disorders               
musculoskeletal discomfort  1  0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 0/6 (0.00%)  0
Nervous system disorders               
headache  1  1/6 (16.67%)  1 1/6 (16.67%)  2 3/6 (50.00%)  4 1/6 (16.67%)  1 0/6 (0.00%)  0 0/6 (0.00%)  0 1/6 (16.67%)  1
Respiratory, thoracic and mediastinal disorders               
cough  1  0/6 (0.00%)  0 2/6 (33.33%)  2 0/6 (0.00%)  0 2/6 (33.33%)  2 0/6 (0.00%)  0 2/6 (33.33%)  2 0/6 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (11.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Respiratory Medical Director
Organization: Sunovion Pharmaceuticals Inc.
Phone: 1-866-503-6351
Layout table for additonal information
Responsible Party: Sunovion Respiratory Development Inc.
ClinicalTrials.gov Identifier: NCT02951312     History of Changes
Other Study ID Numbers: EP-101-01
2009-010821-38 ( EudraCT Number )
First Submitted: October 26, 2016
First Posted: November 1, 2016
Results First Submitted: January 2, 2018
Results First Posted: April 30, 2018
Last Update Posted: April 30, 2018