A Phase IIb Study of Glycopyrrolate Inhalation Solution O... | NCT06545500

NCT06545500

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Dose Level A	Experimental	The treatment period will be 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to	Drug: Glycopyrrolate (85 μg)
Dose Level B	Experimental	The treatment period will be 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to	Drug: Glycopyrrolate (42.5 μg)
Dose Level C	Experimental	The treatment period will be 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to	Drug: Glycopyrrolate (14 μg)
Dose Level D	Placebo Comparator	The treatment period will be 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
Glycopyrrolate (85 μg)	Drug	Administered by a standard jet nebulizer, twice daily for 7 consecutive days	Dose Level A

Outcomes Module

Measure	Description	Time Frame
Change From Average Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1)		Baseline (pre-dose for each treatment period) and Day 7

Secondary Outcomes

Measure	Description	Time Frame
Change From Average Baseline FEV1 to Average Peak FEV1 Measured Over 4 Hours		Baseline (pre-dose for each treatment period) and Day 7
Change From Average Baseline FEV1 to Average FEV1 Area Under the Curve Versus Time From Time 0 to 4 Hours (AUC0-4h)	The endpoint is measured as AUC/4 hour time interval resulting in an average volume measure in liters.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Males are eligible to participate if they agree to use contraception from Screening and throughout the study and for at least 30 days after the last dose of blinded study medication.
Females are eligible to participate if they are not pregnant, not breastfeeding, and ≥ 1 of the following conditions apply:
1. Not a woman of childbearing potential (WOCBP) OR
2. A WOCBP who agrees to follow the contraceptive guidance from Screening and throughout the study and for at least 30 days after the last dose of blinded study medication.
Current or former cigarette smokers with a history of cigarette smoking ≥ 10 pack years at Screening [number of pack years = (number of cigarettes per day / 20) × number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)]. Pipe and/or cigar use cannot be used to calculate pack-year history. Former smokers are defined as those who have stopped smoking for at least 6 months prior to Screening. Smoking cessation programs are permitted during the study.
Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) guidelines with symptoms compatible with COPD.
Post-bronchodilator (4 puffs of salbutamol) spirometry at Screening demonstrating both the following:
1. FEV1/forced vital capacity (FVC) ratio of < 0.70 AND
2. FEV1 ≥ 30 % and ≤ 70% of predicted normal
A posterior-anterior chest x-ray (CXR) at Screening or within 12 months prior to Screening showing no clinically significant abnormalities unrelated to COPD. If a CXR within the past 12 months is not available but a computed tomography (CT) scan within the same time period is available, the CT scan may be reviewed in place of a CXR.
Capable of withdrawing from short-acting bronchodilators for 4 hours prior to spirometry testing and from BID LABA ± ICS therapy for 24 hours prior to spirometry.
Capable of using the study nebulizer correctly.
Ability to perform acceptable spirometry in accordance with ATS/ERS guidelines
Willing and able to attend all study visits and adhere to all study assessments and procedures.

Exclusion Criteria:

Concomitant clinically significant pulmonary disease other than COPD (i.e., asthma, tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, interstitial lung diseases, sleep apnea (unless controlled with stable continuous positive airway pressure [CPAP] use), known alpha-1 antitrypsin deficiency, core pulmonale or other non-specific pulmonary disease).
Within 6 months prior to Screening:
1. COPD exacerbation requiring hospitalization.
2. Use of therapies for COPD exacerbation (e.g., oral, intravenous, or intramuscular glucocorticoids).
Lower respiratory tract infection within 6 weeks of Screening or an active infection at Screening.
History of life-threatening COPD, including Intensive Care Unit admission and/or requiring intubation.
Previous lung resection or lung reduction surgery within 1-year of Screening.
Long term oxygen use defined as oxygen therapy prescribed for greater than 12 hours per day. As needed oxygen use (≤ 12 hours per day) is not exclusionary.
Severe comorbidities including unstable cardiac, or any other clinically significant medical conditions including uncontrolled diseases that would, in the opinion of the Investigator, preclude the subject from safely completing the required tests or the study, or is likely to result in disease progression that would require withdrawal of the subject.
History of or clinically significant on-going bladder outflow obstruction or history of catheterization for relief of bladder outflow obstruction within the previous 6 months.
History of narrow angle glaucoma.
History of hypersensitivity or intolerance to aerosol medications, salbutamol or glycopyrrolate or any of its excipients/components, anticholinergic agents, or sympathomimetic amines.
Pulmonary rehabilitation unless such treatment has been stable from 4 weeks prior to Screening (Visit 1) and remains stable during the study. Pulmonary rehabilitation programs should not be started or completed during participation in the study.
Major surgery (requiring general anesthesia) in the 6 weeks prior to Screening, lack of full recovery from surgery at Screening, or planned surgery through the end of the study.
History of or current malignancy of any organ system, treated or untreated within the past 5 years, except for localized basal or squamous cell carcinoma of the skin.
Current or history of drug or alcohol abuse within the past 5 years.
Estimated glomerular filtration rate (eGFR) < 30 mL/min.
Women who are breast feeding.
Use of an experimental drug within 30 days or within 5 half-lives of Screening, whichever is longer, and/or participation in a study treatment-free follow-up phase of a clinical study within 30 days prior to Screening.
Use of an experimental medical device or participation in a follow-up phase of an experimental medical device clinical study within 30 days prior to Screening.
Affiliation with the investigator site, including an Investigator, Sub-Investigator, study coordinator, study nurse, other employee of participating investigator or study site or a family member of the aforementioned.

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Research of West Florida Inc - Clearwater		Clearwater	Florida	33765	United States
Clinical Research of West Florida Inc - Tampa

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Sequence 1	Participants assigned to treatment Sequence 1 received dose level A for treatment period 1, followed by dose level D for treatment period 2, then dose level B for treatment period 3, and finished with dose level C for treatment period 4
FG001	Sequence 2

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Oct 14, 2024	Dec 4, 2025

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Sequence 1	Participants assigned to treatment Sequence 1 received dose level A for treatment period 1, followed by dose level D for treatment period 2, then dose level B for treatment period 3, and finished with dose level C for treatment period 4
BG001	Sequence 2	Participants assigned to treatment Sequence 2 received dose level B for treatment period 1, followed by dose level A for treatment period 2, then dose level C for treatment period 3, and finished with dose level D for treatment period 4
BG002	Sequence 3	Participants assigned to treatment Sequence 3 received dose level C for treatment period 1, followed by dose level B for treatment period 2, then dose level D for treatment period 3, and finished with dose level A for treatment period 4
BG003	Sequence 4	Participants assigned to treatment Sequence 4 received dose level D for treatment period 1, followed by dose level C for treatment period 2, then dose level A for treatment period 3, and finished with dose level B for treatment period 4
BG004	Total	Total of all reporting groups

Units	Counts
Participants	BG00012 BG00111 BG00212 BG00311 BG00446

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title	Denominators	Categories
	ParticipantsBG00012 ParticipantsBG00111 ParticipantsBG00212 ParticipantsBG003

Sex: Female, Male

Count of Participants

Participants

Title	Denominators	Categories
	ParticipantsBG00012 ParticipantsBG00111 ParticipantsBG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title	Denominators	Categories
White	ParticipantsBG00012 ParticipantsBG00111 ParticipantsBG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title	Denominators	Categories
HISPANIC OR LATINO	ParticipantsBG00012 ParticipantsBG00111 ParticipantsBG002

Region of Enrollment

Count of Participants

Participants

Title	Denominators	Categories
United States	ParticipantsBG00012 ParticipantsBG00111 ParticipantsBG002

Body mass index

Mean

Standard Deviation

kg/m^2

Title	Denominators	Categories
	ParticipantsBG00012 ParticipantsBG00111 ParticipantsBG002

Childbearing potential

Demographic is specific to female population only

Count of Participants

Participants

Title	Denominators	Categories
Yes	ParticipantsBG0008 ParticipantsBG0016 ParticipantsBG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change From Average Baseline in Morning Trough Forced Expiratory Volume in 1 Second (FEV1)

Posted

Least Squares Mean

Standard Error

Liters

Baseline (pre-dose for each treatment period) and Day 7

ID	Title	Description
OG000	Dose Level A Glycopyrrolate (85 μg)	The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to Glycopyrrolate (85 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
OG001	Dose Level B Glycopyrrolate (42.5 μg)	The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to Glycopyrrolate (42.5 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
OG002	Dose Level C Glycopyrrolate (14 μg)	The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to Glycopyrrolate (14 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
OG003	Dose Level D (Placebo)	The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to Placebo: Administered by a standard jet nebulizer, twice daily for 7 consecutive days

Units	Counts
Participants	OG00039 OG00140 OG00241 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000.0525± 0.02125 OG0010.0393± 0.02135 OG0020.0115± 0.02069 OG003

Secondary

Change From Average Baseline FEV1 to Average Peak FEV1 Measured Over 4 Hours

Posted

Least Squares Mean

Standard Error

Liters

Baseline (pre-dose for each treatment period) and Day 7

ID	Title	Description
OG000	Dose Level A Glycopyrrolate (85 μg)	The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to Glycopyrrolate (85 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
OG001	Dose Level B Glycopyrrolate (42.5 μg)	The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to Glycopyrrolate (42.5 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
OG002	Dose Level C Glycopyrrolate (14 μg)	The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to Glycopyrrolate (14 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
OG003	Dose Level D (Placebo)

Secondary

Change From Average Baseline FEV1 to Average FEV1 Area Under the Curve Versus Time From Time 0 to 4 Hours (AUC0-4h)

The endpoint is measured as AUC/4 hour time interval resulting in an average volume measure in liters.

Posted

Least Squares Mean

Standard Error

Liters

Baseline (pre-dose for each treatment period) and Day 7

ID	Title	Description
OG000	Dose Level A Glycopyrrolate (85 μg)	The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to Glycopyrrolate (85 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
OG001	Dose Level B Glycopyrrolate (42.5 μg)	The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to Glycopyrrolate (42.5 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
OG002	Dose Level C Glycopyrrolate (14 μg)	The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to Glycopyrrolate (14 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days

Secondary

Change From Average Baseline FEV1 to Average FEV1 Area Under the Curve Versus Time From Time 0 to 12 Hours (AUC0-12h)

The endpoint is measured as AUC/12 hour time interval resulting in an average volume measure in liters.

Posted

Least Squares Mean

Standard Error

Liters

Baseline (pre-dose for each treatment period) and Day 7

ID	Title	Description
OG000	Dose Level A Glycopyrrolate (85 μg)	The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to Glycopyrrolate (85 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
OG001	Dose Level B Glycopyrrolate (42.5 μg)	The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to Glycopyrrolate (42.5 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
OG002	Dose Level C Glycopyrrolate (14 μg)	The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to Glycopyrrolate (14 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days

Secondary

Change From Average Baseline FEV1 to Evening Trough FEV1

Posted

Least Squares Mean

Standard Error

Liters

Baseline (pre-dose for each treatment period) and Day 7

ID	Title	Description
OG000	Dose Level A Glycopyrrolate (85 μg)	The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to Glycopyrrolate (85 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
OG001	Dose Level B Glycopyrrolate (42.5 μg)	The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to Glycopyrrolate (42.5 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
OG002	Dose Level C Glycopyrrolate (14 μg)	The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to Glycopyrrolate (14 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
OG003	Dose Level D (Placebo)

Secondary

Change From Average Baseline FEV1 to Peak FEV1 Measured Over 4 Hours After First Dose

Posted

Least Squares Mean

Standard Error

Liters

Baseline (pre-dose) and Day 1

ID	Title	Description
OG000	Dose Level A Glycopyrrolate (85 μg)	The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to Glycopyrrolate (85 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
OG001	Dose Level B Glycopyrrolate (42.5 μg)	The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to Glycopyrrolate (42.5 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
OG002	Dose Level C Glycopyrrolate (14 μg)	The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to Glycopyrrolate (14 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
OG003	Dose Level D (Placebo)

Secondary

Change From Average Baseline FEV1 to Average FEV1 AUC0-4h Measured After First Dose

The endpoint is measured as AUC/4 hour time interval resulting in an average volume measure in liters.

Posted

Least Squares Mean

Standard Error

Liters

Baseline (pre-dose) and Day 1

ID	Title	Description
OG000	Dose Level A Glycopyrrolate (85 μg)	The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to Glycopyrrolate (85 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
OG001	Dose Level B Glycopyrrolate (42.5 μg)	The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to Glycopyrrolate (42.5 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
OG002	Dose Level C Glycopyrrolate (14 μg)	The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to Glycopyrrolate (14 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days

Secondary

Number of Treatment Emergent Adverse Events (TEAEs)

Posted

Number

Events

From first dose through the follow-up contact (approximately 8 weeks per participant). Overall safety data was collected for 5 months total.

ID	Title	Description
OG000	Dose Level A Glycopyrrolate (85 μg)	The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to Glycopyrrolate (85 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
OG001	Dose Level B Glycopyrrolate (42.5 μg)	The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to Glycopyrrolate (42.5 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
OG002	Dose Level C Glycopyrrolate (14 μg)	The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to Glycopyrrolate (14 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
OG003	Dose Level D (Placebo)

Secondary

Glycopyrronium Free Base AUC0-12h

Placebo was excluded from the PK concentration listings.

Posted

Mean

Standard Deviation

h*pg/mL

After morning dose Day 7

ID	Title	Description
OG000	Dose Level A Glycopyrrolate (85 μg)	The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to Glycopyrrolate (85 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
OG001	Dose Level B Glycopyrrolate (42.5 μg)	The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to Glycopyrrolate (42.5 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
OG002	Dose Level C Glycopyrrolate (14 μg)	The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to Glycopyrrolate (14 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days

Secondary

Glycopyrronium Free Base Maximum Plasma Drug Concentration (Cmax)

Placebo was excluded from the PK concentration listings.

Posted

Mean

Standard Deviation

pg/mL

After morning dose Day 7

ID	Title	Description
OG000	Dose Level A Glycopyrrolate (85 μg)	The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to Glycopyrrolate (85 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
OG001	Dose Level B Glycopyrrolate (42.5 μg)	The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to Glycopyrrolate (42.5 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
OG002	Dose Level C Glycopyrrolate (14 μg)	The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to Glycopyrrolate (14 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days

Secondary

Glycopyrronium Free Base Time to Maximum Plasma Drug Concentration (Tmax)

Placebo was excluded from the PK concentration listings.

Posted

Median

Full Range

hours

After morning dose Day 7

ID	Title	Description
OG000	Dose Level A Glycopyrrolate (85 μg)	The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to Glycopyrrolate (85 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
OG001	Dose Level B Glycopyrrolate (42.5 μg)	The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to Glycopyrrolate (42.5 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days
OG002	Dose Level C Glycopyrrolate (14 μg)	The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to Glycopyrrolate (14 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days

Arm/Groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (At Risk)
EG000	Dose Level A Glycopyrrolate (85 μg)	The treatment period will be 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to Glycopyrrolate (85 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days	40	2	40	40
EG001	Dose Level B Glycopyrrolate (42.5 μg)	The treatment period will be 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to Glycopyrrolate (42.5 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days	40	1	40	40
EG002	Dose Level C Glycopyrrolate (14 μg)	The treatment period will be 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to Glycopyrrolate (14 μg): Administered by a standard jet nebulizer, twice daily for 7 consecutive days	41	0	41	41
EG003	Dose Level D (Placebo)	The treatment period will be 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to Placebo: Administered by a standard jet nebulizer, twice daily for 7 consecutive days	43	1	43	43

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
CARDIAC FAILURE CONGESTIVE	Cardiac disorders	MedDRA Version 27.0	Systematic Assessment	EG0001 affected40 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG0030 affected43 at risk
INJURY	Injury, poisoning and procedural complications	MedDRA Version 27.0	Systematic Assessment	EG0000 affected40 at risk EG0011 affected40 at risk EG0020 affected41 at risk EG003
CHRONIC OBSTRUCTIVE PULMONARY DISEASE	Respiratory, thoracic and mediastinal disorders	MedDRA Version 27.0	Systematic Assessment	EG0002 affected40 at risk EG0010 affected40 at risk EG0020 affected41 at risk EG003

First MCP Posted Date

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D006024	Glycopyrrolate

Ancestor Terms

ID	Term
D000644	Quaternary Ammonium Compounds
D000588	Amines
D009930	Organic Chemicals
D009861	Onium Compounds
D011759	Pyrrolidines
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to

Placebo: Administered by a standard jet nebulizer, twice daily for 7 consecutive days

The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to

Placebo: Administered by a standard jet nebulizer, twice daily for 7 consecutive days

The treatment period was 7 days, followed by a 7-day washout period, before beginning the next treatment in the sequence they were assigned to

Placebo: Administered by a standard jet nebulizer, twice daily for 7 consecutive days

Units	Counts
Participants	OG00022 OG00122 OG00219