Trial Outcomes & Findings for Assessment of the Safety and Ability of a Once-a-day Dose of an Orally Inhaled Medicine [i.e., Glycopyrrolate Inhalation Solution = GIS] to Improve Airflow in the Lungs When Delivered Using an eFlow Nebulizer in Patients With Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT02948582)

Last Updated: 2018-03-12

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

42 participants

Primary outcome timeframe

24hr post dose

Results posted on

2018-03-12

Participant Flow

All enrolled subjects were randomized. all randomized subjects received at least one dose of study medication

Participant milestones

Participant milestones
Measure	Treatment Group 1 subjects received placebo, glycopyrrolate 400mcg, glycopyrrolate 50 mcg, glycopyrrolate 12.5 mcg, glycoyrrolate 200mcg, or glycopryrrolate 100mcg	Treatment Group 2 subjects received glycopyrrolate 12.5 mcg, glycopyrrolate 50 mcg, glycopryrrolate 100mcg, placebo, glycopyrrolate 200mcg, glycoyrrolate 400mcg, or placebo	Treatment Group 3 subjects received glycopyrrolate 50 mcg, Placebo, glycopyrrolate 200 mcg, glycopryrrolate 100mcg, glycopyrrolate 12.5mcg, or glycoyrrolate 400mcg	Treatment Group 4 subjects received glycopyrrolate 100 mcg, glycopyrrolate 200 mcg, glycopryrrolate 400mcg, placebo, glycopyrrolate 50mcg, or glycoyrrolate 12.5mcg	Treatment Group 5 subjects received glycopyrrolate 200 mcg, glycopyrrolate 12.5 mcg, placebo, glycopryrrolate 400mcg, placebo, glycopyrrolate 100mcg, or glycoyrrolate 50mcg	Treatment Group 6 subjects received glycopyrrolate 400 mcg, glycopyrrolate 100 mcg, glycopryrrolate 12.5mcg, glycopyrrolate 50mcg, placebo or glycoyrrolate 200mcg
Treatment Period 1 STARTED	7	7	7	7	7	7
Treatment Period 1 COMPLETED	7	7	7	7	7	7
Treatment Period 1 NOT COMPLETED	0	0	0	0	0	0
Washout Period 1 STARTED	7	7	7	7	7	7
Washout Period 1 COMPLETED	7	5	7	7	7	6
Washout Period 1 NOT COMPLETED	0	2	0	0	0	1
Treatment Period 2 STARTED	7	5	7	7	7	6
Treatment Period 2 COMPLETED	7	5	7	7	7	6
Treatment Period 2 NOT COMPLETED	0	0	0	0	0	0
Washout Period 2 STARTED	7	5	7	7	7	6
Washout Period 2 COMPLETED	7	4	7	6	7	6
Washout Period 2 NOT COMPLETED	0	1	0	1	0	0
Treatment Period 3 STARTED	7	4	7	6	7	6
Treatment Period 3 COMPLETED	7	4	7	6	7	6
Treatment Period 3 NOT COMPLETED	0	0	0	0	0	0
Washout Period 3 STARTED	7	4	7	6	7	6
Washout Period 3 COMPLETED	7	4	7	6	7	6
Washout Period 3 NOT COMPLETED	0	0	0	0	0	0
Treatment Period 4 STARTED	7	4	7	6	7	6
Treatment Period 4 COMPLETED	7	4	7	6	7	6
Treatment Period 4 NOT COMPLETED	0	0	0	0	0	0
Washout Period 4 STARTED	7	4	7	6	7	6
Washout Period 4 COMPLETED	6	4	6	6	7	6
Washout Period 4 NOT COMPLETED	1	0	1	0	0	0
Treatment Period 5 STARTED	6	4	6	6	7	6
Treatment Period 5 COMPLETED	6	4	6	6	7	6
Treatment Period 5 NOT COMPLETED	0	0	0	0	0	0
Washout Period 5 STARTED	6	4	6	6	7	6
Washout Period 5 COMPLETED	6	4	6	6	7	6
Washout Period 5 NOT COMPLETED	0	0	0	0	0	0
Treatment Period 6 STARTED	6	4	6	6	7	6
Treatment Period 6 COMPLETED	6	4	6	6	7	6
Treatment Period 6 NOT COMPLETED	0	0	0	0	0	0
Wshout Period 6 STARTED	6	4	6	6	7	6
Wshout Period 6 COMPLETED	6	4	6	6	7	6
Wshout Period 6 NOT COMPLETED	0	0	0	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment Group 1 subjects received placebo, glycopyrrolate 400mcg, glycopyrrolate 50 mcg, glycopyrrolate 12.5 mcg, glycoyrrolate 200mcg, or glycopryrrolate 100mcg	Treatment Group 2 subjects received glycopyrrolate 12.5 mcg, glycopyrrolate 50 mcg, glycopryrrolate 100mcg, placebo, glycopyrrolate 200mcg, glycoyrrolate 400mcg, or placebo	Treatment Group 3 subjects received glycopyrrolate 50 mcg, Placebo, glycopyrrolate 200 mcg, glycopryrrolate 100mcg, glycopyrrolate 12.5mcg, or glycoyrrolate 400mcg	Treatment Group 4 subjects received glycopyrrolate 100 mcg, glycopyrrolate 200 mcg, glycopryrrolate 400mcg, placebo, glycopyrrolate 50mcg, or glycoyrrolate 12.5mcg	Treatment Group 6 subjects received glycopyrrolate 400 mcg, glycopyrrolate 100 mcg, glycopryrrolate 12.5mcg, glycopyrrolate 50mcg, placebo or glycoyrrolate 200mcg
Washout Period 1 Adverse Event	0	2	0	0	0
Washout Period 1 Protocol Violation	0	0	0	0	1
Washout Period 2 Adverse Event	0	1	0	0	0
Washout Period 2 personal reasons	0	0	0	1	0
Washout Period 4 Adverse Event	1	0	1	0	0

Baseline Characteristics

Assessment of the Safety and Ability of a Once-a-day Dose of an Orally Inhaled Medicine [i.e., Glycopyrrolate Inhalation Solution = GIS] to Improve Airflow in the Lungs When Delivered Using an eFlow Nebulizer in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Total Participants n=42 Participants Intent to treat population same as safety population -not full analysis set
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants
Age, Categorical >=65 years	13 Participants n=5 Participants
Age, Continuous	62.0 years STANDARD_DEVIATION 6.99 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	42 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	41 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United Kingdom	42 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24hr post dose

Population: 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.

Outcome measures

Outcome measures
Measure	Glycopyrrolate Inhalation Solution12.5μg n=38 Participants Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution12.5μg: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 50μg n=38 Participants Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 50μg: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 100μg n=37 Participants Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 200μg n=37 Participants Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 400μg n=37 Participants Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily	Placebo 0.5mL n=37 Participants Placebo 0.5mL via e-flow nebulizer, once daily Placebo 0.5mL: Placebo 0.5mL via eFlow, once daily
Trough FEV1 (Change From Baseline)	-0.093 liters Standard Deviation 0.1189	0.0114 liters Standard Deviation 0.1308	0.0447 liters Standard Deviation 0.1548	0.0542 liters Standard Deviation 0.1779	0.0292 liters Standard Deviation 0.1468	-0.0612 liters Standard Deviation 0.1233

PRIMARY outcome

Timeframe: 0-12h post dose

Population: 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

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.

Outcome measures

Outcome measures
Measure	Glycopyrrolate Inhalation Solution12.5μg n=39 Participants Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution12.5μg: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 50μg n=38 Participants Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 50μg: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 100μg n=37 Participants Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 200μg n=37 Participants Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 400μg n=37 Participants Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily	Placebo 0.5mL n=37 Participants Placebo 0.5mL via e-flow nebulizer, once daily Placebo 0.5mL: Placebo 0.5mL via eFlow, once daily
Standardized FEV1AUC0-12 Area Under the FEV1 Curve From 0 to 12 Hours Post-dose ( Actual and Change From Baseline). actual standardized FEV1 AUC0_12	1.259 liters Standard Deviation 0.409	1.311 liters Standard Deviation 0.422	1.335 liters Standard Deviation 0.394	1.374 liters Standard Deviation 0.391	1.390 liters Standard Deviation 0.423	1.180 liters Standard Deviation 0.427
Standardized FEV1AUC0-12 Area Under the FEV1 Curve From 0 to 12 Hours Post-dose ( Actual and Change From Baseline). change from baseline standardized FEV1 AUC0_12	0.055 liters Standard Deviation 0.113	0.126 liters Standard Deviation 0.112	0.136 liters Standard Deviation 0.134	0.184 liters Standard Deviation 0.134	0.170 liters Standard Deviation 0.110	-0.024 liters Standard Deviation 0.095

PRIMARY outcome

Timeframe: 12-24h post dose

Population: 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

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.

Outcome measures

Outcome measures
Measure	Glycopyrrolate Inhalation Solution12.5μg n=39 Participants Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution12.5μg: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 50μg n=38 Participants Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 50μg: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 100μg n=37 Participants Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 200μg n=37 Participants Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 400μg n=37 Participants Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily	Placebo 0.5mL n=37 Participants Placebo 0.5mL via e-flow nebulizer, once daily Placebo 0.5mL: Placebo 0.5mL via eFlow, once daily
Standardized FEV1AUC12-24 Area Under the FEV1 Curve From 12 to 24 Hours Post- Dose (Actual and Change From Baseline). acutal standardized FEV1 AUC0_12	1.165 liters Standard Deviation 0.377	1.203 liters Standard Deviation 0.404	1.227 liters Standard Deviation 0.369	1.253 liters Standard Deviation 0.346	1.259 liters Standard Deviation 0.396	1.123 liters Standard Deviation 0.392
Standardized FEV1AUC12-24 Area Under the FEV1 Curve From 12 to 24 Hours Post- Dose (Actual and Change From Baseline). change from baseline standardized FEV1 AUC0_12	-0.038 liters Standard Deviation 0.132	0.018 liters Standard Deviation 0.135	0.028 liters Standard Deviation 0.138	0.063 liters Standard Deviation 0.178	0.039 liters Standard Deviation 0.135	-0.082 liters Standard Deviation 0.120

PRIMARY outcome

Timeframe: 0 to 24h

Population: 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

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.

Outcome measures

Outcome measures
Measure	Glycopyrrolate Inhalation Solution12.5μg n=39 Participants Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution12.5μg: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 50μg n=38 Participants Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 50μg: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 100μg n=37 Participants Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 200μg n=37 Participants Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 400μg n=37 Participants Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily	Placebo 0.5mL n=37 Participants Placebo 0.5mL via e-flow nebulizer, once daily Placebo 0.5mL: Placebo 0.5mL via eFlow, once daily
Standardized FEV1 AUC0-24 Area Under the FEV1 Curve From 0 to 24 Hours Post-dose (Actual and Change Baseline) Actual standardized FEV1 AUC0_12	1.212 liters Standard Deviation 0.391	1.257 liters Standard Deviation 0.411	1.281 liters Standard Deviation 0.379	1.313 liters Standard Deviation 0.364	1.325 liters Standard Deviation 0.407	1.151 liters Standard Deviation 0.408
Standardized FEV1 AUC0-24 Area Under the FEV1 Curve From 0 to 24 Hours Post-dose (Actual and Change Baseline) change from baseline standardized FEV1 AUC0_12	0.009 liters Standard Deviation 0.114	0.072 liters Standard Deviation 0.115	0.082 liters Standard Deviation 0.128	0.123 liters Standard Deviation 0.146	0.105 liters Standard Deviation 0.113	-0.053 liters Standard Deviation 0.102

PRIMARY outcome

Timeframe: 0-4h post dose

Population: 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

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.

Outcome measures

Outcome measures
Measure	Glycopyrrolate Inhalation Solution12.5μg n=39 Participants Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution12.5μg: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 50μg n=38 Participants Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 50μg: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 100μg n=37 Participants Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 200μg n=37 Participants Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 400μg n=37 Participants Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily	Placebo 0.5mL n=37 Participants Placebo 0.5mL via e-flow nebulizer, once daily Placebo 0.5mL: Placebo 0.5mL via eFlow, once daily
Peak FEV1 (Change From Baseline and Percent Change) Change from baseline	0.165 liters Standard Deviation 0.113	0.229 liters Standard Deviation 0.113	0.260 liters Standard Deviation 0.151	0.292 liters Standard Deviation 0.120	0.272 liters Standard Deviation 0.125	0.061 liters Standard Deviation 0.102
Peak FEV1 (Change From Baseline and Percent Change) percent change from baseline	15.30 liters Standard Deviation 11.37	21.05 liters Standard Deviation 11.87	24.14 liters Standard Deviation 20.69	26.73 liters Standard Deviation 12.56	25.44 liters Standard Deviation 15.10	5.24 liters Standard Deviation 8275

SECONDARY outcome

Timeframe: 0 to 12 hour

Population: 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.

Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr

Outcome measures

Outcome measures
Measure	Glycopyrrolate Inhalation Solution12.5μg n=2 Participants Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution12.5μg: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 50μg n=13 Participants Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 50μg: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 100μg n=12 Participants Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 200μg n=12 Participants Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 400μg n=13 Participants Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily	Placebo 0.5mL Placebo 0.5mL via e-flow nebulizer, once daily Placebo 0.5mL: Placebo 0.5mL via eFlow, once daily
Cmax; Maximum Observed Plasma Concentration	59.25 pg/mL Geometric Coefficient of Variation 78.49	74.48 pg/mL Geometric Coefficient of Variation 62.24	144.58 pg/mL Geometric Coefficient of Variation 52.53	316.05 pg/mL Geometric Coefficient of Variation 48.35	504.93 pg/mL Geometric Coefficient of Variation 55.67	—

SECONDARY outcome

Timeframe: 0 to 12 hours

Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr

Outcome measures

Outcome measures
Measure	Glycopyrrolate Inhalation Solution12.5μg n=2 Participants Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution12.5μg: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 50μg n=13 Participants Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 50μg: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 100μg n=12 Participants Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 200μg n=12 Participants Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 400μg n=12 Participants Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily	Placebo 0.5mL Placebo 0.5mL via e-flow nebulizer, once daily Placebo 0.5mL: Placebo 0.5mL via eFlow, once daily
Tmax; Time to Maximum Observed Plasma Concentration	0.165 hours Interval 0.15 to 0.18	0.320 hours Interval 0.015 to 0.35	0.260 hours Interval 0.15 to 0.33	0.275 hours Interval 0.15 to 0.38	0.180 hours Interval 0.15 to 0.32	—

SECONDARY outcome

Timeframe: 0 to 12 hour

Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr

Outcome measures

Outcome measures
Measure	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	Glycopyrrolate Inhalation Solution 50μg n=2 Participants Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 50μg: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 100μg n=4 Participants Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 200μg n=7 Participants Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 400μg n=6 Participants Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily	Placebo 0.5mL Placebo 0.5mL via e-flow nebulizer, once daily Placebo 0.5mL: Placebo 0.5mL via eFlow, once daily
t1/2; Plasma Half-life	—	0.8949 hours Geometric Coefficient of Variation 2.3707	3.0137 hours Geometric Coefficient of Variation 50.7557	3.1663 hours Geometric Coefficient of Variation 45.4839	4.1238 hours Geometric Coefficient of Variation 63.5353	—

SECONDARY outcome

Timeframe: 0 to 12 hour

Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr

Outcome measures

Outcome measures
Measure	Glycopyrrolate Inhalation Solution12.5μg n=2 Participants Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution12.5μg: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 50μg n=13 Participants Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 50μg: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 100μg n=12 Participants Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 200μg n=12 Participants Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 400μg n=13 Participants Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily	Placebo 0.5mL Placebo 0.5mL via e-flow nebulizer, once daily Placebo 0.5mL: Placebo 0.5mL via eFlow, once daily
AUC0-t; Area Under the Plasma Concentration-time Curve From Time Zero to Time of Last Measurable Drug Concentration.	135.87 pg.h/ml Geometric Coefficient of Variation 209.27	67.18 pg.h/ml Geometric Coefficient of Variation 143.22	237.80 pg.h/ml Geometric Coefficient of Variation 98.45	677.24 pg.h/ml Geometric Coefficient of Variation 66.34	1481.36 pg.h/ml Geometric Coefficient of Variation 82.17	—

SECONDARY outcome

Timeframe: 0 to 12 hour

Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr

Outcome measures

Outcome measures
Measure	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	Glycopyrrolate Inhalation Solution 50μg n=2 Participants Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 50μg: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 100μg n=4 Participants Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 200μg n=7 Participants Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 400μg n=6 Participants Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily	Placebo 0.5mL Placebo 0.5mL via e-flow nebulizer, once daily Placebo 0.5mL: Placebo 0.5mL via eFlow, once daily
AUC0-inf Area Under the Plasma Concentration-time Curve From Time Zero to Infinity	—	246.84 pg.h/ml Geometric Coefficient of Variation 37.49	634.65 pg.h/ml Geometric Coefficient of Variation 34.28	772.59 pg.h/ml Geometric Coefficient of Variation 26.30	1367.76 pg.h/ml Geometric Coefficient of Variation 76.70	—

SECONDARY outcome

Timeframe: Day 69 (includes dosing Day 1, washout Day 12, safety follow up Day 69)

Population: all subjects who received at least one dose of study drug were included in the safety analysis

AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment

Outcome measures

Outcome measures
Measure	Glycopyrrolate Inhalation Solution12.5μg n=39 Participants Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution12.5μg: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 50μg n=38 Participants Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 50μg: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 100μg n=37 Participants Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 200μg n=37 Participants Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 400μg n=37 Participants Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily	Placebo 0.5mL n=37 Participants Placebo 0.5mL via e-flow nebulizer, once daily Placebo 0.5mL: Placebo 0.5mL via eFlow, once daily
Number of Subjects Who Died, Number of Subjects With Treatment Emergent SAEs, Number of Subjects Who Discontinued Due to AE subjects who died	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants
Number of Subjects Who Died, Number of Subjects With Treatment Emergent SAEs, Number of Subjects Who Discontinued Due to AE subjects with treatment emergent SAEs	0 participants	0 participants	1 participants	0 participants	0 participants	0 participants
Number of Subjects Who Died, Number of Subjects With Treatment Emergent SAEs, Number of Subjects Who Discontinued Due to AE Subjects whodiscontinued due to an AE	2 participants	2 participants	2 participants	0 participants	0 participants	0 participants
Number of Subjects Who Died, Number of Subjects With Treatment Emergent SAEs, Number of Subjects Who Discontinued Due to AE subjects with treatment emergent AEs	16 participants	14 participants	17 participants	15 participants	13 participants	14 participants

SECONDARY outcome

Timeframe: 0-24 h

Population: all subjects who received at least one does of study drug were included in the safety analysis

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.

Outcome measures

Outcome measures
Measure	Glycopyrrolate Inhalation Solution12.5μg n=39 Participants Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution12.5μg: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 50μg n=38 Participants Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 50μg: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 100μg n=37 Participants Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 200μg n=37 Participants Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 400μg n=37 Participants Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily	Placebo 0.5mL n=37 Participants Placebo 0.5mL via e-flow nebulizer, once daily Placebo 0.5mL: Placebo 0.5mL via eFlow, once daily
Number of Subjects With Clinically Significant Abnormal Vital Signs Reported During the Study	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day -14, Day 69

Population: all subjects who received at least one dose of study drug were included in the safety analysis

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.

Outcome measures

Outcome measures
Measure	Glycopyrrolate Inhalation Solution12.5μg n=39 Participants Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution12.5μg: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 50μg n=38 Participants Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 50μg: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 100μg n=37 Participants Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 200μg n=37 Participants Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 400μg n=37 Participants Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily	Placebo 0.5mL n=37 Participants Placebo 0.5mL via e-flow nebulizer, once daily Placebo 0.5mL: Placebo 0.5mL via eFlow, once daily
Number of Clinically Significant Abnormal Laboratory Results Reported During the Study	0 number of events	0 number of events	0 number of events	0 number of events	0 number of events	0 number of events

SECONDARY outcome

Timeframe: 0 to 24h

Population: all subjects who received at least one dose of study drug were included in the safety analysis

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.

Outcome measures

Outcome measures
Measure	Glycopyrrolate Inhalation Solution12.5μg n=39 Participants Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution12.5μg: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 50μg n=38 Participants Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 50μg: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 100μg n=37 Participants Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 200μg n=37 Participants Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 400μg n=37 Participants Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily	Placebo 0.5mL n=37 Participants Placebo 0.5mL via e-flow nebulizer, once daily Placebo 0.5mL: Placebo 0.5mL via eFlow, once daily
Number of Subjects With Clinically Significant ECG Parameters Reported During the Study	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Day 69 (includes dosing Day 1, washout Day 12, safety follow up Day 69)

Population: all subjects who received at least one dose of study drug were included in the safety analysis

AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment

Outcome measures

Outcome measures
Measure	Glycopyrrolate Inhalation Solution12.5μg n=39 Participants Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution12.5μg: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 50μg n=38 Participants Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 50μg: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 100μg n=37 Participants Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 200μg n=37 Participants Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 400μg n=37 Participants Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily	Placebo 0.5mL n=37 Participants Placebo 0.5mL via e-flow nebulizer, once daily Placebo 0.5mL: Placebo 0.5mL via eFlow, once daily
Percentage of Subjects With Treatment Emergent AEs	41.0 percentage of participants	36.8 percentage of participants	45.9 percentage of participants	40.5 percentage of participants	35.1 percentage of participants	37.8 percentage of participants

Adverse Events

Glycopyrrolate Inhalation Solution12.5μg

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Glycopyrrolate Inhalation Solution 50μg

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Glycopyrrolate Inhalation Solution 100μg

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Glycopyrrolate Inhalation Solution 200μg

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Glycopyrrolate Inhalation Solution 400μg

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Placebo 0.5mL

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Glycopyrrolate Inhalation Solution12.5μg n=39 participants at risk Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution12.5μg: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 50μg n=38 participants at risk Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 50μg: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 100μg n=37 participants at risk Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 200μg n=37 participants at risk Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 400μg n=37 participants at risk Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily	Placebo 0.5mL n=37 participants at risk Placebo 0.5mL via e-flow nebulizer, once daily Placebo 0.5mL: Placebo 0.5mL via eFlow, once daily
General disorders groin pain	0.00% 0/39 • 0-69 days AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment	0.00% 0/38 • 0-69 days AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment	2.7% 1/37 • Number of events 2 • 0-69 days AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment	0.00% 0/37 • 0-69 days AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment	0.00% 0/37 • 0-69 days AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment	0.00% 0/37 • 0-69 days AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment

Other adverse events

Other adverse events
Measure	Glycopyrrolate Inhalation Solution12.5μg n=39 participants at risk Glycopyrrolate Inhalation Solution12.5μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution12.5μg: Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 50μg n=38 participants at risk Glycopyrrolate Inhalation Solution 50mg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 50μg: Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 100μg n=37 participants at risk Glycopyrrolate Inhalation Solution 100μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 100μg: Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 200μg n=37 participants at risk Glycopyrrolate Inhalation Solution 200μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 200μg: Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily	Glycopyrrolate Inhalation Solution 400μg n=37 participants at risk Glycopyrrolate Inhalation Solution 400μg via e-flow nebulizer, once daily Glycopyrrolate Inhalation Solution 400μg: Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily	Placebo 0.5mL n=37 participants at risk Placebo 0.5mL via e-flow nebulizer, once daily Placebo 0.5mL: Placebo 0.5mL via eFlow, once daily
Injury, poisoning and procedural complications skin injury	0.00% 0/39 • 0-69 days AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment	0.00% 0/38 • 0-69 days AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment	0.00% 0/37 • 0-69 days AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment	0.00% 0/37 • 0-69 days AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment	0.00% 0/37 • 0-69 days AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment	5.4% 2/37 • Number of events 2 • 0-69 days AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
Nervous system disorders headache	15.4% 6/39 • Number of events 7 • 0-69 days AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment	13.2% 5/38 • Number of events 6 • 0-69 days AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment	13.5% 5/37 • Number of events 8 • 0-69 days AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment	18.9% 7/37 • Number of events 9 • 0-69 days AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment	16.2% 6/37 • Number of events 8 • 0-69 days AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment	10.8% 4/37 • Number of events 5 • 0-69 days AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
Respiratory, thoracic and mediastinal disorders chronic obstructive pulmonary disease	5.1% 2/39 • Number of events 2 • 0-69 days AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment	2.6% 1/38 • Number of events 1 • 0-69 days AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment	0.00% 0/37 • 0-69 days AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment	0.00% 0/37 • 0-69 days AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment	0.00% 0/37 • 0-69 days AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment	0.00% 0/37 • 0-69 days AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
Respiratory, thoracic and mediastinal disorders cough	7.7% 3/39 • Number of events 3 • 0-69 days AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment	5.3% 2/38 • Number of events 2 • 0-69 days AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment	13.5% 5/37 • Number of events 5 • 0-69 days AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment	8.1% 3/37 • Number of events 3 • 0-69 days AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment	8.1% 3/37 • Number of events 4 • 0-69 days AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment	13.5% 5/37 • Number of events 5 • 0-69 days AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment
Respiratory, thoracic and mediastinal disorders dyspnoea	7.7% 3/39 • Number of events 3 • 0-69 days AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment	5.3% 2/38 • Number of events 2 • 0-69 days AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment	2.7% 1/37 • Number of events 1 • 0-69 days AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment	2.7% 1/37 • Number of events 2 • 0-69 days AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment	2.7% 1/37 • Number of events 1 • 0-69 days AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment	5.4% 2/37 • Number of events 3 • 0-69 days AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment

Additional Information

Respiratory Medical Director

Sunovion Pharmaceuticals Inc.

Phone: 1-866-503-6351

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER