Glycopyrrolate/Formoterol Fumarate MDI Compared With Spiriva® as An Active Control in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

A Randomized, Double Blind, (Test Products), Chronic Dosing (7 Days), Four Period, Eight Treatment , Incomplete Block, Cross Over, Multi Center Study to Assess Efficacy and Safety of Five Doses of PT003, One Dose of PT001 and One Dose of PT005 in Patients With Moderate to Severe COPD, Compared With Spiriva® Handihaler® (Tiotropium Bromide 18 µg, Open Label) as Active Control

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01587079

Enrollment

159

Registered

2012-04-27

Start date

2012-04-30

Completion date

2012-10-31

Last updated

2016-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD

Brief summary

The primary objective of this study is to assess the efficacy of Glycopyrrolate/Formoterol Fumarate MDI relative to individual components (GP MDI and FF MDI) in subjects with moderate to severe COPD

Interventions

DRUGPT003

PT003 MDI administered as two puffs BID for 7 days

DRUGPT001

PT001 MDI administered as two puffs BID for 7 days

DRUGPT005

PT005 MDI administered as two puffs BID for 7 days

DRUGTiotropium inhalation powder

Taken as 1 capsule containing 18 µg of Tiotropium via the Handihaler DPI for 7 days

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

Healthy volunteers

Inclusion criteria

Key Inclusion Criteria: * Signed written informed consent * 40 - 80 years of age * Clinical history of COPD with airflow limitation that is not fully reversible * Females of non-child bearing potential or females of child bearing potential with negative pregnancy test and acceptable contraceptive methods * Current/former smokers with at least a 10 pack-year history of cigarette smoking * A measured post-bronchodilator FEV1/FVC ratio of \< or = 0.70 * A measured post-bronchodilator FEV1 \> or = 750ml or 30% predicted and \< or = 80% of predicted normal values * Able to change COPD treatment as required by protocol Key

Exclusion criteria

* Women who are pregnant or lactating * Primary diagnosis of asthma * Alpha-1 antitrypsin deficiency as the cause of COPD * Active pulmonary diseases * Prior lung volume reduction surgery * Abnormal chest X-ray not due to the presence of COPD * Hospitalized due to poorly controlled COPD within 3 months of Screening * Clinically significant medical conditions that preclude participation in the study (e.g. clinically significant abnormal ECG, uncontrolled hypertension, glaucoma, symptomatic prostatic hypertrophy) * Cancer that has not been in complete remission for at least 5 years * Treatment with investigational study drug or participation in another clinical trial or study within the last 30 days or 5 half lives Other inclusion/

Design outcomes

Primary

Measure	Time frame	Description
FEV1 AUC 0-12 on Day 7	Day 7	FEV1 AUC 0-12

Secondary

Measure	Time frame	Description
Peak Change From Baseline in FEV1 on Treatment Day 1	Day 1	Peak change from Baseline in FEV1 on Treatment
Time to Onset of Action (>10% Improvement in FEV1) on Day 1	Day 1	Time to onset of action (\>10% improvement in FEV1)
Proportion of Subjects Achieving >=12% Improvement in FEV1 on Day 1	Day 1	Proportion of subjects achieving \>=12% improvement in FEV1
Peak Change From Baseline in Inspiratory Capacity on Day 1	Day 1	Peak change from baseline in Inspiratory Capacity
Change From Baseline in Morning Pre-dose Trough FEV1 on Day 7	Day 7	Change from baseline in morning pre-dose trough FEV1
Peak Change From Baseline in FEV1 on Day 7	Day 7	Peak change from baseline in FEV1 Day 7
Change From Baseline in Morning Pre-dose Trough IC on Day 7	Day 7	Change from baseline in morning pre-dose trough IC
Peak Change From Baseline IC on Day 7	Day 7	Peak change from baseline IC
Change From Baseline at Evening 12-hour Post-dose Trough FEV1 on Day 7	Day 7	Change from baseline at evening 12-hour post-dose trough FEV1
Change From Baseline in Mean Morning Pre-dose Daily Peak Flow Readings on Day 7	Day 7	Change from baseline in mean morning pre-dose daily peak flow readings
Change From Baseline in Mean Morning Post-dose Daily Peak Flow Readings on Day 7	Day 7	Change from baseline in mean morning post-dose daily peak flow readings on
Change From Baseline in Mean Evening Pre-dose Daily Peak Flow Readings on Day 7	Day 7	Change from baseline in mean evening pre-dose daily peak flow readings (BID treatments only)
Change From Baseline in Mean Evening Post-dose Daily Peak Flow Readings on Day 7	Day 7	Change from baseline in mean evening post-dose daily peak flow readings (12 Hours post-dose for Spiriva)

Countries

United States

Participant flow

Recruitment details

The study was conducted at 20 sites in the US from May 2012 until September 2012. The entire study was scheduled to take a maximum of 19 weeks for each individual subject.

Pre-assignment details

Study was a chronic dosing (7 days), 4-period, 8-treatment, Incomplete Block, Cross-Over.

Participants by arm

Arm	Count
All Subjects Screened	159
Total	159

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	14
Overall Study	Lost to Follow-up	2
Overall Study	Physician Decision	2
Overall Study	Protocol-specified criteria	9
Overall Study	Protocol Violation	5
Overall Study	Withdrawal by Subject	7

Baseline characteristics

Characteristic	All Subjects Screened
Age, Continuous Age, years	62.8 years STANDARD_DEVIATION 8.6
Sex: Female, Male Female	76 Participants 47.8
Sex: Female, Male Male	83 Participants 52.2

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk	EG007 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —
other Total, other adverse events	8 / 66	2 / 71	8 / 70	5 / 67	9 / 71	2 / 68	8 / 73	6 / 71
serious Total, serious adverse events	1 / 66	1 / 71	0 / 70	0 / 67	1 / 71	2 / 68	1 / 73	0 / 71

Outcome results

Primary

FEV1 AUC 0-12 on Day 7

FEV1 AUC 0-12

Time frame: Day 7

Population: MITT

Arm	Measure	Value (LEAST_SQUARES_MEAN)
GP MDI 18 μg (PT001)	FEV1 AUC 0-12 on Day 7	1.452 Liters
GFF MDI 18/9.6 μg (PT003)	FEV1 AUC 0-12 on Day 7	1.591 Liters
GFF/MDI 9/9.6 μg	FEV1 AUC 0-12 on Day 7	1.547 Liters
GFF MDI BID 4.6/9.6 μg	FEV1 AUC 0-12 on Day 7	1.539 Liters
GFF MDI 2.4/9.6 μg (PT003)	FEV1 AUC 0-12 on Day 7	1.538 Liters
GFF MDI 1.2/9.6 μg (PT003)	FEV1 AUC 0-12 on Day 7	1.508 Liters
FF MDI 9.6 μg	FEV1 AUC 0-12 on Day 7	1.467 Liters
Spiriva 18 μg QD	FEV1 AUC 0-12 on Day 7	1.489 Liters

Secondary

Change From Baseline at Evening 12-hour Post-dose Trough FEV1 on Day 7

Change from baseline at evening 12-hour post-dose trough FEV1

Time frame: Day 7

Population: MITT

Arm	Measure	Value (LEAST_SQUARES_MEAN)
GP MDI 18 μg (PT001)	Change From Baseline at Evening 12-hour Post-dose Trough FEV1 on Day 7	99 Millliters
GFF MDI 18/9.6 μg (PT003)	Change From Baseline at Evening 12-hour Post-dose Trough FEV1 on Day 7	196 Millliters
GFF/MDI 9/9.6 μg	Change From Baseline at Evening 12-hour Post-dose Trough FEV1 on Day 7	162 Millliters
GFF MDI BID 4.6/9.6 μg	Change From Baseline at Evening 12-hour Post-dose Trough FEV1 on Day 7	118 Millliters
GFF MDI 2.4/9.6 μg (PT003)	Change From Baseline at Evening 12-hour Post-dose Trough FEV1 on Day 7	133 Millliters
GFF MDI 1.2/9.6 μg (PT003)	Change From Baseline at Evening 12-hour Post-dose Trough FEV1 on Day 7	110 Millliters
FF MDI 9.6 μg	Change From Baseline at Evening 12-hour Post-dose Trough FEV1 on Day 7	73 Millliters
Spiriva 18 μg QD	Change From Baseline at Evening 12-hour Post-dose Trough FEV1 on Day 7	130 Millliters

Secondary

Change From Baseline in Mean Evening Post-dose Daily Peak Flow Readings on Day 7

Change from baseline in mean evening post-dose daily peak flow readings (12 Hours post-dose for Spiriva)

Time frame: Day 7

Population: MITT

Arm	Measure	Value (LEAST_SQUARES_MEAN)
GP MDI 18 μg (PT001)	Change From Baseline in Mean Evening Post-dose Daily Peak Flow Readings on Day 7	35.0 L/min
GFF MDI 18/9.6 μg (PT003)	Change From Baseline in Mean Evening Post-dose Daily Peak Flow Readings on Day 7	61.5 L/min
GFF/MDI 9/9.6 μg	Change From Baseline in Mean Evening Post-dose Daily Peak Flow Readings on Day 7	56.1 L/min
GFF MDI BID 4.6/9.6 μg	Change From Baseline in Mean Evening Post-dose Daily Peak Flow Readings on Day 7	51.5 L/min
GFF MDI 2.4/9.6 μg (PT003)	Change From Baseline in Mean Evening Post-dose Daily Peak Flow Readings on Day 7	53.7 L/min
GFF MDI 1.2/9.6 μg (PT003)	Change From Baseline in Mean Evening Post-dose Daily Peak Flow Readings on Day 7	53.8 L/min
FF MDI 9.6 μg	Change From Baseline in Mean Evening Post-dose Daily Peak Flow Readings on Day 7	48.3 L/min
Spiriva 18 μg QD	Change From Baseline in Mean Evening Post-dose Daily Peak Flow Readings on Day 7	30.3 L/min

Secondary

Change From Baseline in Mean Evening Pre-dose Daily Peak Flow Readings on Day 7

Change from baseline in mean evening pre-dose daily peak flow readings (BID treatments only)

Time frame: Day 7

Population: MITT

Arm	Measure	Value (LEAST_SQUARES_MEAN)
GP MDI 18 μg (PT001)	Change From Baseline in Mean Evening Pre-dose Daily Peak Flow Readings on Day 7	11.7 L/min
GFF MDI 18/9.6 μg (PT003)	Change From Baseline in Mean Evening Pre-dose Daily Peak Flow Readings on Day 7	32.5 L/min
GFF/MDI 9/9.6 μg	Change From Baseline in Mean Evening Pre-dose Daily Peak Flow Readings on Day 7	25.0 L/min
GFF MDI BID 4.6/9.6 μg	Change From Baseline in Mean Evening Pre-dose Daily Peak Flow Readings on Day 7	19.0 L/min
GFF MDI 2.4/9.6 μg (PT003)	Change From Baseline in Mean Evening Pre-dose Daily Peak Flow Readings on Day 7	25.6 L/min
GFF MDI 1.2/9.6 μg (PT003)	Change From Baseline in Mean Evening Pre-dose Daily Peak Flow Readings on Day 7	19.9 L/min
FF MDI 9.6 μg	Change From Baseline in Mean Evening Pre-dose Daily Peak Flow Readings on Day 7	16.5 L/min

Secondary

Change From Baseline in Mean Morning Post-dose Daily Peak Flow Readings on Day 7

Change from baseline in mean morning post-dose daily peak flow readings on

Time frame: Day 7

Population: MITT

Arm	Measure	Value (LEAST_SQUARES_MEAN)
GP MDI 18 μg (PT001)	Change From Baseline in Mean Morning Post-dose Daily Peak Flow Readings on Day 7	31.0 L/min
GFF MDI 18/9.6 μg (PT003)	Change From Baseline in Mean Morning Post-dose Daily Peak Flow Readings on Day 7	58.8 L/min
GFF/MDI 9/9.6 μg	Change From Baseline in Mean Morning Post-dose Daily Peak Flow Readings on Day 7	55.0 L/min
GFF MDI BID 4.6/9.6 μg	Change From Baseline in Mean Morning Post-dose Daily Peak Flow Readings on Day 7	46.7 L/min
GFF MDI 2.4/9.6 μg (PT003)	Change From Baseline in Mean Morning Post-dose Daily Peak Flow Readings on Day 7	52.1 L/min
GFF MDI 1.2/9.6 μg (PT003)	Change From Baseline in Mean Morning Post-dose Daily Peak Flow Readings on Day 7	49.6 L/min
FF MDI 9.6 μg	Change From Baseline in Mean Morning Post-dose Daily Peak Flow Readings on Day 7	43.2 L/min
Spiriva 18 μg QD	Change From Baseline in Mean Morning Post-dose Daily Peak Flow Readings on Day 7	37.9 L/min

Secondary

Change From Baseline in Mean Morning Pre-dose Daily Peak Flow Readings on Day 7

Change from baseline in mean morning pre-dose daily peak flow readings

Time frame: Day 7

Population: MITT

Arm	Measure	Value (LEAST_SQUARES_MEAN)
GP MDI 18 μg (PT001)	Change From Baseline in Mean Morning Pre-dose Daily Peak Flow Readings on Day 7	7.6 L/min
GFF MDI 18/9.6 μg (PT003)	Change From Baseline in Mean Morning Pre-dose Daily Peak Flow Readings on Day 7	25.2 L/min
GFF/MDI 9/9.6 μg	Change From Baseline in Mean Morning Pre-dose Daily Peak Flow Readings on Day 7	16.6 L/min
GFF MDI BID 4.6/9.6 μg	Change From Baseline in Mean Morning Pre-dose Daily Peak Flow Readings on Day 7	12.4 L/min
GFF MDI 2.4/9.6 μg (PT003)	Change From Baseline in Mean Morning Pre-dose Daily Peak Flow Readings on Day 7	18.0 L/min
GFF MDI 1.2/9.6 μg (PT003)	Change From Baseline in Mean Morning Pre-dose Daily Peak Flow Readings on Day 7	13.8 L/min
FF MDI 9.6 μg	Change From Baseline in Mean Morning Pre-dose Daily Peak Flow Readings on Day 7	8.6 L/min
Spiriva 18 μg QD	Change From Baseline in Mean Morning Pre-dose Daily Peak Flow Readings on Day 7	11.6 L/min

Secondary

Change From Baseline in Morning Pre-dose Trough FEV1 on Day 7

Change from baseline in morning pre-dose trough FEV1

Time frame: Day 7

Population: MITT

Arm	Measure	Value (LEAST_SQUARES_MEAN)
GP MDI 18 μg (PT001)	Change From Baseline in Morning Pre-dose Trough FEV1 on Day 7	120 Milliliters
GFF MDI 18/9.6 μg (PT003)	Change From Baseline in Morning Pre-dose Trough FEV1 on Day 7	183 Milliliters
GFF/MDI 9/9.6 μg	Change From Baseline in Morning Pre-dose Trough FEV1 on Day 7	150 Milliliters
GFF MDI BID 4.6/9.6 μg	Change From Baseline in Morning Pre-dose Trough FEV1 on Day 7	154 Milliliters
GFF MDI 2.4/9.6 μg (PT003)	Change From Baseline in Morning Pre-dose Trough FEV1 on Day 7	163 Milliliters
GFF MDI 1.2/9.6 μg (PT003)	Change From Baseline in Morning Pre-dose Trough FEV1 on Day 7	130 Milliliters
FF MDI 9.6 μg	Change From Baseline in Morning Pre-dose Trough FEV1 on Day 7	104 Milliliters
Spiriva 18 μg QD	Change From Baseline in Morning Pre-dose Trough FEV1 on Day 7	122 Milliliters

Secondary

Change From Baseline in Morning Pre-dose Trough IC on Day 7

Change from baseline in morning pre-dose trough IC

Time frame: Day 7

Population: MITT

Arm	Measure	Value (LEAST_SQUARES_MEAN)
GP MDI 18 μg (PT001)	Change From Baseline in Morning Pre-dose Trough IC on Day 7	109 Millliters
GFF MDI 18/9.6 μg (PT003)	Change From Baseline in Morning Pre-dose Trough IC on Day 7	185 Millliters
GFF/MDI 9/9.6 μg	Change From Baseline in Morning Pre-dose Trough IC on Day 7	183 Millliters
GFF MDI BID 4.6/9.6 μg	Change From Baseline in Morning Pre-dose Trough IC on Day 7	215 Millliters
GFF MDI 2.4/9.6 μg (PT003)	Change From Baseline in Morning Pre-dose Trough IC on Day 7	203 Millliters
GFF MDI 1.2/9.6 μg (PT003)	Change From Baseline in Morning Pre-dose Trough IC on Day 7	151 Millliters
FF MDI 9.6 μg	Change From Baseline in Morning Pre-dose Trough IC on Day 7	129 Millliters
Spiriva 18 μg QD	Change From Baseline in Morning Pre-dose Trough IC on Day 7	106 Millliters

Secondary

Peak Change From Baseline IC on Day 7

Peak change from baseline IC

Time frame: Day 7

Population: MITT

Arm	Measure	Value (LEAST_SQUARES_MEAN)
GP MDI 18 μg (PT001)	Peak Change From Baseline IC on Day 7	223 Millliters
GFF MDI 18/9.6 μg (PT003)	Peak Change From Baseline IC on Day 7	430 Millliters
GFF/MDI 9/9.6 μg	Peak Change From Baseline IC on Day 7	441 Millliters
GFF MDI BID 4.6/9.6 μg	Peak Change From Baseline IC on Day 7	409 Millliters
GFF MDI 2.4/9.6 μg (PT003)	Peak Change From Baseline IC on Day 7	368 Millliters
GFF MDI 1.2/9.6 μg (PT003)	Peak Change From Baseline IC on Day 7	371 Millliters
FF MDI 9.6 μg	Peak Change From Baseline IC on Day 7	377 Millliters
Spiriva 18 μg QD	Peak Change From Baseline IC on Day 7	241 Millliters

Secondary

Peak Change From Baseline in FEV1 on Day 7

Peak change from baseline in FEV1 Day 7

Time frame: Day 7

Population: MITT

Arm	Measure	Value (LEAST_SQUARES_MEAN)
GP MDI 18 μg (PT001)	Peak Change From Baseline in FEV1 on Day 7	300 Millliters
GFF MDI 18/9.6 μg (PT003)	Peak Change From Baseline in FEV1 on Day 7	444 Millliters
GFF/MDI 9/9.6 μg	Peak Change From Baseline in FEV1 on Day 7	414 Millliters
GFF MDI BID 4.6/9.6 μg	Peak Change From Baseline in FEV1 on Day 7	403 Millliters
GFF MDI 2.4/9.6 μg (PT003)	Peak Change From Baseline in FEV1 on Day 7	388 Millliters
GFF MDI 1.2/9.6 μg (PT003)	Peak Change From Baseline in FEV1 on Day 7	363 Millliters
FF MDI 9.6 μg	Peak Change From Baseline in FEV1 on Day 7	332 Millliters
Spiriva 18 μg QD	Peak Change From Baseline in FEV1 on Day 7	309 Millliters

Secondary

Peak Change From Baseline in FEV1 on Treatment Day 1

Peak change from Baseline in FEV1 on Treatment

Time frame: Day 1

Population: MITT

Arm	Measure	Value (LEAST_SQUARES_MEAN)
GP MDI 18 μg (PT001)	Peak Change From Baseline in FEV1 on Treatment Day 1	209 Milliliters
GFF MDI 18/9.6 μg (PT003)	Peak Change From Baseline in FEV1 on Treatment Day 1	339 Milliliters
GFF/MDI 9/9.6 μg	Peak Change From Baseline in FEV1 on Treatment Day 1	329 Milliliters
GFF MDI BID 4.6/9.6 μg	Peak Change From Baseline in FEV1 on Treatment Day 1	348 Milliliters
GFF MDI 2.4/9.6 μg (PT003)	Peak Change From Baseline in FEV1 on Treatment Day 1	333 Milliliters
GFF MDI 1.2/9.6 μg (PT003)	Peak Change From Baseline in FEV1 on Treatment Day 1	312 Milliliters
FF MDI 9.6 μg	Peak Change From Baseline in FEV1 on Treatment Day 1	317 Milliliters
Spiriva 18 μg QD	Peak Change From Baseline in FEV1 on Treatment Day 1	238 Milliliters

Secondary

Peak Change From Baseline in Inspiratory Capacity on Day 1

Peak change from baseline in Inspiratory Capacity

Time frame: Day 1

Population: MITT

Arm	Measure	Value (LEAST_SQUARES_MEAN)
GP MDI 18 μg (PT001)	Peak Change From Baseline in Inspiratory Capacity on Day 1	204 Milliliters
GFF MDI 18/9.6 μg (PT003)	Peak Change From Baseline in Inspiratory Capacity on Day 1	393 Milliliters
GFF/MDI 9/9.6 μg	Peak Change From Baseline in Inspiratory Capacity on Day 1	320 Milliliters
GFF MDI BID 4.6/9.6 μg	Peak Change From Baseline in Inspiratory Capacity on Day 1	387 Milliliters
GFF MDI 2.4/9.6 μg (PT003)	Peak Change From Baseline in Inspiratory Capacity on Day 1	347 Milliliters
GFF MDI 1.2/9.6 μg (PT003)	Peak Change From Baseline in Inspiratory Capacity on Day 1	348 Milliliters
FF MDI 9.6 μg	Peak Change From Baseline in Inspiratory Capacity on Day 1	335 Milliliters
Spiriva 18 μg QD	Peak Change From Baseline in Inspiratory Capacity on Day 1	233 Milliliters

Secondary

Proportion of Subjects Achieving >=12% Improvement in FEV1 on Day 1

Proportion of subjects achieving \>=12% improvement in FEV1

Time frame: Day 1

Population: MITT

Arm	Measure	Value (NUMBER)
GP MDI 18 μg (PT001)	Proportion of Subjects Achieving >=12% Improvement in FEV1 on Day 1	56 Percentage
GFF MDI 18/9.6 μg (PT003)	Proportion of Subjects Achieving >=12% Improvement in FEV1 on Day 1	93 Percentage
GFF/MDI 9/9.6 μg	Proportion of Subjects Achieving >=12% Improvement in FEV1 on Day 1	85 Percentage
GFF MDI BID 4.6/9.6 μg	Proportion of Subjects Achieving >=12% Improvement in FEV1 on Day 1	84 Percentage
GFF MDI 2.4/9.6 μg (PT003)	Proportion of Subjects Achieving >=12% Improvement in FEV1 on Day 1	86 Percentage
GFF MDI 1.2/9.6 μg (PT003)	Proportion of Subjects Achieving >=12% Improvement in FEV1 on Day 1	83 Percentage
FF MDI 9.6 μg	Proportion of Subjects Achieving >=12% Improvement in FEV1 on Day 1	80 Percentage
Spiriva 18 μg QD	Proportion of Subjects Achieving >=12% Improvement in FEV1 on Day 1	72 Percentage

Secondary

Time to Onset of Action (>10% Improvement in FEV1) on Day 1

Time to onset of action (\>10% improvement in FEV1)

Time frame: Day 1

Population: MITT

Arm	Measure	Group	Value (NUMBER)
GP MDI 18 μg (PT001)	Time to Onset of Action (>10% Improvement in FEV1) on Day 1	15 minutes	27 Percentage
GP MDI 18 μg (PT001)	Time to Onset of Action (>10% Improvement in FEV1) on Day 1	No onset within 2 hours	40 Percentage
GP MDI 18 μg (PT001)	Time to Onset of Action (>10% Improvement in FEV1) on Day 1	2 hours	10 Percentage
GP MDI 18 μg (PT001)	Time to Onset of Action (>10% Improvement in FEV1) on Day 1	1 hour	15 Percentage
GP MDI 18 μg (PT001)	Time to Onset of Action (>10% Improvement in FEV1) on Day 1	30 minutes	8 Percentage
GFF MDI 18/9.6 μg (PT003)	Time to Onset of Action (>10% Improvement in FEV1) on Day 1	30 minutes	18 Percentage
GFF MDI 18/9.6 μg (PT003)	Time to Onset of Action (>10% Improvement in FEV1) on Day 1	2 hours	5 Percentage
GFF MDI 18/9.6 μg (PT003)	Time to Onset of Action (>10% Improvement in FEV1) on Day 1	No onset within 2 hours	6 Percentage
GFF MDI 18/9.6 μg (PT003)	Time to Onset of Action (>10% Improvement in FEV1) on Day 1	1 hour	6 Percentage
GFF MDI 18/9.6 μg (PT003)	Time to Onset of Action (>10% Improvement in FEV1) on Day 1	15 minutes	65 Percentage
GFF/MDI 9/9.6 μg	Time to Onset of Action (>10% Improvement in FEV1) on Day 1	30 minutes	13 Percentage
GFF/MDI 9/9.6 μg	Time to Onset of Action (>10% Improvement in FEV1) on Day 1	No onset within 2 hours	18 Percentage
GFF/MDI 9/9.6 μg	Time to Onset of Action (>10% Improvement in FEV1) on Day 1	15 minutes	51 Percentage
GFF/MDI 9/9.6 μg	Time to Onset of Action (>10% Improvement in FEV1) on Day 1	2 hours	7 Percentage
GFF/MDI 9/9.6 μg	Time to Onset of Action (>10% Improvement in FEV1) on Day 1	1 hour	11 Percentage
GFF MDI BID 4.6/9.6 μg	Time to Onset of Action (>10% Improvement in FEV1) on Day 1	1 hour	12 Percentage
GFF MDI BID 4.6/9.6 μg	Time to Onset of Action (>10% Improvement in FEV1) on Day 1	No onset within 2 hours	10 Percentage
GFF MDI BID 4.6/9.6 μg	Time to Onset of Action (>10% Improvement in FEV1) on Day 1	15 minutes	62 Percentage
GFF MDI BID 4.6/9.6 μg	Time to Onset of Action (>10% Improvement in FEV1) on Day 1	30 minutes	10 Percentage
GFF MDI BID 4.6/9.6 μg	Time to Onset of Action (>10% Improvement in FEV1) on Day 1	2 hours	5 Percentage
GFF MDI 2.4/9.6 μg (PT003)	Time to Onset of Action (>10% Improvement in FEV1) on Day 1	1 hour	12 Percentage
GFF MDI 2.4/9.6 μg (PT003)	Time to Onset of Action (>10% Improvement in FEV1) on Day 1	15 minutes	65 Percentage
GFF MDI 2.4/9.6 μg (PT003)	Time to Onset of Action (>10% Improvement in FEV1) on Day 1	30 minutes	10 Percentage
GFF MDI 2.4/9.6 μg (PT003)	Time to Onset of Action (>10% Improvement in FEV1) on Day 1	2 hours	2 Percentage
GFF MDI 2.4/9.6 μg (PT003)	Time to Onset of Action (>10% Improvement in FEV1) on Day 1	No onset within 2 hours	12 Percentage
GFF MDI 1.2/9.6 μg (PT003)	Time to Onset of Action (>10% Improvement in FEV1) on Day 1	1 hour	5 Percentage
GFF MDI 1.2/9.6 μg (PT003)	Time to Onset of Action (>10% Improvement in FEV1) on Day 1	2 hours	9 Percentage
GFF MDI 1.2/9.6 μg (PT003)	Time to Onset of Action (>10% Improvement in FEV1) on Day 1	30 minutes	9 Percentage
GFF MDI 1.2/9.6 μg (PT003)	Time to Onset of Action (>10% Improvement in FEV1) on Day 1	15 minutes	66 Percentage
GFF MDI 1.2/9.6 μg (PT003)	Time to Onset of Action (>10% Improvement in FEV1) on Day 1	No onset within 2 hours	11 Percentage
FF MDI 9.6 μg	Time to Onset of Action (>10% Improvement in FEV1) on Day 1	1 hour	12 Percentage
FF MDI 9.6 μg	Time to Onset of Action (>10% Improvement in FEV1) on Day 1	15 minutes	60 Percentage
FF MDI 9.6 μg	Time to Onset of Action (>10% Improvement in FEV1) on Day 1	30 minutes	3 Percentage
FF MDI 9.6 μg	Time to Onset of Action (>10% Improvement in FEV1) on Day 1	No onset within 2 hours	22 Percentage
FF MDI 9.6 μg	Time to Onset of Action (>10% Improvement in FEV1) on Day 1	2 hours	3 Percentage
Spiriva 18 μg QD	Time to Onset of Action (>10% Improvement in FEV1) on Day 1	No onset within 2 hours	26 Percentage
Spiriva 18 μg QD	Time to Onset of Action (>10% Improvement in FEV1) on Day 1	2 hours	5 Percentage
Spiriva 18 μg QD	Time to Onset of Action (>10% Improvement in FEV1) on Day 1	15 minutes	37 Percentage
Spiriva 18 μg QD	Time to Onset of Action (>10% Improvement in FEV1) on Day 1	1 hour	11 Percentage
Spiriva 18 μg QD	Time to Onset of Action (>10% Improvement in FEV1) on Day 1	30 minutes	21 Percentage

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026

Glycopyrrolate/Formoterol Fumarate MDI Compared With Spiriva® as An Active Control in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

FEV1 AUC 0-12 on Day 7

Change From Baseline at Evening 12-hour Post-dose Trough FEV1 on Day 7

Change From Baseline in Mean Evening Post-dose Daily Peak Flow Readings on Day 7

Change From Baseline in Mean Evening Pre-dose Daily Peak Flow Readings on Day 7

Change From Baseline in Mean Morning Post-dose Daily Peak Flow Readings on Day 7

Change From Baseline in Mean Morning Pre-dose Daily Peak Flow Readings on Day 7

Change From Baseline in Morning Pre-dose Trough FEV1 on Day 7

Change From Baseline in Morning Pre-dose Trough IC on Day 7

Peak Change From Baseline IC on Day 7

Peak Change From Baseline in FEV1 on Day 7

Peak Change From Baseline in FEV1 on Treatment Day 1

Peak Change From Baseline in Inspiratory Capacity on Day 1

Proportion of Subjects Achieving >=12% Improvement in FEV1 on Day 1

Time to Onset of Action (>10% Improvement in FEV1) on Day 1