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Showing 1–16 of 16 matching trials from the live ClinicalTrials.gov search.
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Filters: Intervention: PT003 Clear all
Completed Phase 1 Interventional Accepts healthy volunteers

Phase I Study Evaluating the Safety and Pharmacokinetics of Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (BGF MDI) in Healthy Volunteers

NCT01980615
View directory record Official record
Conditions
Healthy Volunteers
Interventions
Inhaled BGF (PT010) Dose 1, Inhaled BGF (PT010) Dose 2, Inhaled BGF (PT010) Dose 3, Inhaled GFF (PT003), Inhaled Symbicort Dose 1, Inhaled Symbicort Dose 2
Drug
Lead sponsor
Pearl Therapeutics, Inc.
Industry
Eligibility
18 Years to 45 Years
Enrollment
84 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
2013
U.S. locations
1
States / cities
Baltimore, Maryland
Source: ClinicalTrials.gov public record
Updated Apr 13, 2014 · Synced Sep 4, 2026, 7:26 AM EDT
Completed Phase 1 Interventional Accepts healthy volunteers Results available

PK Study of PT003 and PT001 in Japanese Healthy Subjects

NCT02196714
View directory record Official record
Conditions
COPD
Interventions
Glycopyrronium and Formoterol Fumarate (GFF) Dose 1, Glycopyrronium and Formoterol Fumarate (GFF) Dose 2, Glycopyrronium (GP) Dose 1, Glycopyrronium (GP) Dose 2
Drug
Lead sponsor
Pearl Therapeutics, Inc.
Industry
Eligibility
18 Years to 45 Years
Enrollment
24 participants
Healthy volunteers
Accepts healthy volunteers
Timeline
Started 2014
U.S. locations
1
States / cities
Baltimore, Maryland
Source: ClinicalTrials.gov public record
Updated Apr 25, 2017 · Synced Sep 4, 2026, 7:26 AM EDT
Completed Phase 2 Interventional Results available

PT003 MDI Dose Confirmation Study

NCT01349816
View directory record Official record
Conditions
Chronic Obstructive Pulmonary Disease
Interventions
PT003, PT001, PT005
Drug
Lead sponsor
Pearl Therapeutics, Inc.
Industry
Eligibility
40 Years to 80 Years
Enrollment
185 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011
U.S. locations
13
States / cities
Rancho Mirage, California • Colorado Springs, Colorado • Waterbury, Connecticut + 10 more
Source: ClinicalTrials.gov public record
Updated Apr 26, 2017 · Synced Sep 4, 2026, 7:26 AM EDT
Completed Phase 3 Interventional Results available

Multi-Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD (PINNACLE 2)

NCT01854658
View directory record Official record
Conditions
Chronic Obstructive Pulmonary Disease (COPD)
Interventions
GFF MDI (PT003), GP MDI (PT001), FF MDI (PT005), Placebo
Drug
Lead sponsor
Pearl Therapeutics, Inc.
Industry
Eligibility
40 Years to 80 Years
Enrollment
1,615 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2015
U.S. locations
113
States / cities
Birmingham, Alabama • Florence, Alabama • Jasper, Alabama + 110 more
Source: ClinicalTrials.gov public record
Updated Mar 27, 2017 · Synced Sep 4, 2026, 7:26 AM EDT
Completed Phase 3 Interventional Results available

Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD); (PINNACLE 1)

NCT01854645
View directory record Official record
Conditions
Chronic Obstructive Pulmonary Disease
Interventions
GFF MDI, GP MDI, FF MDI, Open-label tiotropium bromide inhalation powder (Spiriva® Handihaler®), Placebo MDI
Drug
Lead sponsor
Pearl Therapeutics, Inc.
Industry
Eligibility
40 Years to 80 Years
Enrollment
2,103 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2015
U.S. locations
121
States / cities
Andalusia, Alabama • Anniston, Alabama • Athens, Alabama + 118 more
Source: ClinicalTrials.gov public record
Updated Mar 27, 2017 · Synced Sep 4, 2026, 7:26 AM EDT
Completed Phase 3 Interventional Results available

Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

NCT02536508
View directory record Official record
Conditions
COPD
Interventions
BGF MDI 320/14.4/9.6 μg, GFF MDI 14.4/9.6 μg, BFF MDI 320/9.6 μg
Drug
Lead sponsor
Pearl Therapeutics, Inc.
Industry
Eligibility
40 Years to 80 Years
Enrollment
627 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2017
U.S. locations
64
States / cities
Dothan, Alabama • Jasper, Alabama • Peoria, Arizona + 56 more
Source: ClinicalTrials.gov public record
Updated Feb 25, 2021 · Synced Sep 4, 2026, 7:26 AM EDT
Completed Phase 2 Interventional Results available

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

NCT01587079
View directory record Official record
Conditions
Chronic Obstructive Pulmonary Disease
Interventions
PT003, PT001, PT005, Tiotropium inhalation powder
Drug
Lead sponsor
Pearl Therapeutics, Inc.
Industry
Eligibility
40 Years to 80 Years
Enrollment
159 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2012
U.S. locations
19
States / cities
Glendale, Arizona • Rancho Mirage, California • Waterbury, Connecticut + 14 more
Source: ClinicalTrials.gov public record
Updated Jun 29, 2016 · Synced Sep 4, 2026, 7:26 AM EDT
Completed Phase 3 Interventional Results available

A Randomized, Double-Blind, Parallel-Group, 24-Week, Chronic-Dosing, Multi-Center Study to Assess the Efficacy and Safety of PT010, PT003, and PT009 Compared With Symbicort® Turbuhaler® (Kronos)

NCT02497001
View directory record Official record
Conditions
COPD
Interventions
BGF MDI 320/14.4/9.6 μg, GFF MDI (PT003) 14.4/9.6 μg, BFF MDI (PT009) 320/9.6 μg, Symbicort® Turbuhaler® (TBH) Inhalation Powder
Drug
Lead sponsor
Pearl Therapeutics, Inc.
Industry
Eligibility
40 Years to 80 Years
Enrollment
1,902 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2018
U.S. locations
63
States / cities
Andalusia, Alabama • Jasper, Alabama • Peoria, Arizona + 54 more
Source: ClinicalTrials.gov public record
Updated Dec 23, 2020 · Synced Sep 4, 2026, 7:26 AM EDT
Completed Phase 3 Interventional Results available

Extension Study to Evaluate the Safety and Efficacy of PT003, PT001, and PT005 in Subjects With Moderate to Very Severe COPD, With Spiriva® Handihaler® (PINNACLE 3)

NCT01970878
View directory record Official record
Conditions
Chronic Obstructive Pulmonary Disease (COPD)
Interventions
GFF MDI (PT 003), GP MDI (PT001), FF MDI (PT005), Open-label tiotropium bromide inhalation (Spiriva® Handihaler®)
Drug
Lead sponsor
Pearl Therapeutics, Inc.
Industry
Eligibility
40 Years to 80 Years
Enrollment
892 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2013 – 2015
U.S. locations
110
States / cities
Andalusia, Alabama • Anniston, Alabama • Athens, Alabama + 107 more
Source: ClinicalTrials.gov public record
Updated Mar 16, 2017 · Synced Sep 4, 2026, 7:26 AM EDT
Completed Phase 3 Interventional Results available

Crossover Study to Assess the Efficacy of PT003 With and Without a Valved Holding Chamber in Subjects With Moderate to Severe COPD

NCT02454959
View directory record Official record
Conditions
COPD
Interventions
GFF MDI (PT003) with Aerochamber, GFF MDI (PT003) without Aerochamber
Device
Lead sponsor
Pearl Therapeutics, Inc.
Industry
Eligibility
40 Years to 80 Years
Enrollment
80 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2016
U.S. locations
6
States / cities
Clearwater, Florida • Tampa, Florida • Winter Park, Florida + 3 more
Source: ClinicalTrials.gov public record
Updated Apr 18, 2017 · Synced Sep 4, 2026, 7:26 AM EDT
Completed Phase 3 Interventional Results available

Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 in Subjects With Moderate to Very Severe COPD (Ethos)

NCT02465567
View directory record Official record
Conditions
COPD
Interventions
BGF MDI 320/14.4/9.6 μg, GFF MDI 14.4/9.6 μg, BGF MDI 160/14.4/9.6 μg, BFF MDI 320/9.6 μg
Drug
Lead sponsor
Pearl Therapeutics, Inc.
Industry
Eligibility
40 Years to 80 Years
Enrollment
8,588 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2019
U.S. locations
318
States / cities
Andalusia, Alabama • Athens, Alabama • Birmingham, Alabama + 249 more
Source: ClinicalTrials.gov public record
Updated Feb 1, 2021 · Synced Sep 4, 2026, 7:26 AM EDT
Completed Phase 2 Interventional Results available

Study to Evaluate the Efficacy, Safety and Pharmacokinetics of PT001, PT003, and PT005 Following Chronic Dosing (7 Days) in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

NCT01085045
View directory record Official record
Conditions
Chronic Obstructive Pulmonary Disease
Interventions
PT003 MDI, PT005 MDI, Placebo MDI, Tiotropium bromide 18 μg (Spiriva Handihaler®), Formoterol Fumarate 12 μg (Foradil® Aerolizer®), PT001 MDI
Drug
Lead sponsor
Pearl Therapeutics, Inc.
Industry
Eligibility
40 Years to 80 Years
Enrollment
118 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2010
U.S. locations
4
States / cities
Clearwater, Florida • Charlotte, North Carolina • Medford, Oregon + 1 more
Source: ClinicalTrials.gov public record
Updated Apr 25, 2017 · Synced Sep 4, 2026, 7:26 AM EDT
Completed Phase 2 Interventional Results available

PT003 MDI Cardiovascular Safety Study

NCT01349803
View directory record Official record
Conditions
Chronic Obstructive Pulmonary Disease
Interventions
PT005 MDI, PT001 MDI, PT003 MDI, Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
Drug
Lead sponsor
Pearl Therapeutics, Inc.
Industry
Eligibility
40 Years to 80 Years
Enrollment
237 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2011
U.S. locations
10
States / cities
Glendale, Arizona • Fullerton, California • Los Angeles, California + 7 more
Source: ClinicalTrials.gov public record
Updated Jan 30, 2017 · Synced Sep 4, 2026, 7:26 AM EDT
Completed Phase 3 Interventional Results available

Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD

NCT02343458
View directory record Official record
Conditions
Chronic Obstructive Pulmonary Disease
Interventions
GFF MDI (PT003), FF MDI (PT005), GP MDI (PT001), Placebo MDI
Drug
Lead sponsor
Pearl Therapeutics, Inc.
Industry
Eligibility
40 Years to 80 Years
Enrollment
1,756 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2015 – 2017
U.S. locations
44
States / cities
Andalusia, Alabama • Birmingham, Alabama • Foley, Alabama + 37 more
Source: ClinicalTrials.gov public record
Updated Feb 19, 2019 · Synced Sep 4, 2026, 7:26 AM EDT
Completed Phase 3 Interventional Results available

Glycopyrronium and Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) Dose Indicator Study in Adults With Moderate to Very Severe COPD

NCT02268396
View directory record Official record
Conditions
COPD
Interventions
Glycopyrronium and Formoterol Fumarate Metered-dose Inhaler
Drug
Lead sponsor
Pearl Therapeutics, Inc.
Industry
Eligibility
40 Years to 80 Years
Enrollment
138 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2014 – 2015
U.S. locations
10
States / cities
Clearwater, Florida • Tampa, Florida • Winter Park, Florida + 7 more
Source: ClinicalTrials.gov public record
Updated Dec 22, 2016 · Synced Sep 4, 2026, 7:26 AM EDT
Terminated Phase 3 Interventional Results available

Study to Evaluate the Treatment Effect of PT003 on Cardiovascular Hemodynamics in Subjects With Moderate to Severe COPD

NCT02685293
View directory record Official record
Conditions
COPD
Interventions
GFF MDI (PT003), Placebo MDI
Drug
Lead sponsor
Pearl Therapeutics, Inc.
Industry
Eligibility
40 Years to 80 Years
Enrollment
4 participants
Healthy volunteers
Healthy volunteers not accepted
Timeline
2016 – 2018
U.S. locations
1
States / cities
Birmingham, Alabama
Source: ClinicalTrials.gov public record
Updated Aug 27, 2019 · Synced Sep 4, 2026, 7:26 AM EDT