Study to Assess the Safety and Tolerability of PT010, PT0... | NCT02536508

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BGF MDI (PT010) 320/14.4/9.6 μg	Experimental	Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) metered dose inhaler (MDI) (PT010, BGF MDI)	Drug: BGF MDI 320/14.4/9.6 μg
GFF MDI (PT003) 14.4/9.6 μg	Experimental	Glycopyrronium and Formoterol Fumarate (GFF) metered dose inhaler (MDI) (PT003, GFF MDI)	Drug: GFF MDI 14.4/9.6 μg
BFF MDI (PT009) 320/9.6 μg	Experimental	Budesonide and Formoterol Fumarate (BFF) metered dose inhaler (MDI) (PT009, BFF MDI)	Drug: BFF MDI 320/9.6 μg

Name	Type	Description	Arm Group Labels	Other Names
BGF MDI 320/14.4/9.6 μg	Drug	Budesonide, Glycopyrronium, and Formoterol Fumarate	BGF MDI (PT010) 320/14.4/9.6 μg

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent Change From Baseline in BMD of the Lumbar Spine	Percent change from baseline in BMD of the lumbar spine T-Score at Week 52.	at week 52
Change From Baseline in the LOCS III (P) Score at Week 52	Change from baseline in the LOCS III (P) score (Severity of Posterior Subcapsular Cataract) at Week 52. P score is reported as a decimalized scale ranging from 0.1 (indicating a completely clear or colorless lens) to 5.9 (indicating complete opacification on the posterior capsule). A negative change in P score indicates an improvement and a positive change indicates a deterioration of LOCS III. A change in P score within 0.5 is an acceptable variation margin.	at week 52

Eligibility Module

Name	Affiliation	Role
Colin Reisner	Pearl Therapeutics	Study Director
Paul Dorinsky, MD	Pearl Therapeutics	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Dothan	Alabama	36303	United States
Research Site

PubMed Identifier	Type	Citation	Retractions
35815359	Derived	Singh D, Hurst JR, Martinez FJ, Rabe KF, Bafadhel M, Jenkins M, Salazar D, Dorinsky P, Darken P. Predictive modeling of COPD exacerbation rates using baseline risk factors. Ther Adv Respir Dis. 2022 Jan-Dec;16:17534666221107314. doi: 10.1177/17534666221107314.

Label	URL
PT010008-01\_Protocol\_Version\_2.0\_REDACTED.pdf	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	BGF MDI 320/14.4/9.6 ug	Budesonide Gylcopyrronium and Formoterol Fumarate Inhalation Aerosol 320/14.4/9.6 ug
FG001	GFF MDI 14.4/9.6 ug	Glycopyrronium and Formoterol Fumarate Inhalation Aerosol 14.4/9.6 ug

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 18, 2016	Apr 22, 2020

Arm/Group Information

ID	Title	Description
BG000	BGF MDI 320/14.4/9.6 ug	Budesonide Gylcopyrronium and Formoterol Fumarate Inhalation Aerosol 320/14.4/9.6 ug
BG001	GFF MDI 14.4/9.6 ug	Glycopyrronium and Formoterol Fumarate Inhalation Aerosol 14.4/9.6 ug
BG002	BFF MDI 320/9.6 ug	Budesonide and Formoterol Fumarate Inhalation Aerosol 320/9.6 ug
BG003	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Safety Population

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00062.6± 7.9 BG00162.4± 7.8 BG00264.0± 7.2 BG003

Sex: Female, Male

Safety Population

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00092 BG00187 BG002

Ethnicity (NIH/OMB)

Safety Population

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG0009 BG0015 BG002

Race/Ethnicity, Customized

Safety Population

Number

Participants

Title

Denominators

Categories

Black

Title	Measurements
	BG00013 BG00117 BG002

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

Percent Change From Baseline in BMD of the Lumbar Spine

Percent change from baseline in BMD of the lumbar spine T-Score at Week 52.

BMD Population was defined as all evaluable subjects in the Safety Population who had a baseline BMD assessment and at least 1 on-treatment BMD assessment. Subjects were analyzed according to actual study drug received.

Posted

Least Squares Mean

95% Confidence Interval

Percentage

at week 52

ID	Title	Description
OG000	BGF MDI 320/14.4/9.6 ug	Budesonide Gylcopyrronium and Formoterol Fumarate Inhalation Aerosol 320/14.4/9.6 ug
OG001	GFF MDI 14.4/9.6 ug	Glycopyrronium and Formoterol Fumarate Inhalation Aerosol 14.4/9.6 ug
OG002	BFF MDI 320/9.6 ug	Budesonide and Formoterol Fumarate Inhalation Aerosol 320/9.6 ug

Units	Counts
Participants	OG000128 OG001123 OG00257

Title

Denominators

Categories

Title	Measurements
	OG000-0.093(-0.739 to 0.557) OG0010.379(-0.28 to 1.042) OG002-0.120(-1.087 to 0.857)

Primary

Change From Baseline in the LOCS III (P) Score at Week 52

Change from baseline in the LOCS III (P) score (Severity of Posterior Subcapsular Cataract) at Week 52. P score is reported as a decimalized scale ranging from 0.1 (indicating a completely clear or colorless lens) to 5.9 (indicating complete opacification on the posterior capsule). A negative change in P score indicates an improvement and a positive change indicates a deterioration of LOCS III. A change in P score within 0.5 is an acceptable variation margin.

Ophthalmologic Population was defined as all evaluable subjects in the Safety Population who had a baseline ophthalmologic assessment and at least 1 on-treatment ophthalmologic assessment. Subjects were analyzed according to actual study drug received.

Posted

Least Squares Mean

95% Confidence Interval

P-Score

at week 52

ID	Title	Description
OG000	BGF MDI 320/14.4/9.6 ug	Budesonide Gylcopyrronium and Formoterol Fumarate Inhalation Aerosol 320/14.4/9.6 ug
OG001	GFF MDI 14.4/9.6 ug	Glycopyrronium and Formoterol Fumarate Inhalation Aerosol 14.4/9.6 ug
OG002	BFF MDI 320/9.6 ug	Budesonide and Formoterol Fumarate Inhalation Aerosol 320/9.6 ug

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	BGF MDI 320/14.4/9.6 ug	Budesonide Gylcopyrronium and Formoterol Fumarate Inhalation Aerosol 320/14.4/9.6 ug	3	194	33	194	62	194
EG001	GFF MDI 14.4/9.6 ug	Glycopyrronium and Formoterol Fumarate Inhalation Aerosol 14.4/9.6 ug	1	174	22	174	51	174
EG002	BFF MDI 320/9.6 ug	Budesonide and Formoterol Fumarate Inhalation Aerosol 320/9.6 ug	0	88	7	88	30	88

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Chronic Pulmonary Obstructive Disease	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG00013 events12 affected194 at risk EG00111 events9 affected174 at risk EG0023 events2 affected88 at risk
Acute Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected194 at risk EG0012 events2 affected174 at risk EG0020 events0 affected88 at risk
Respiratory Failure	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected194 at risk EG0010 events0 affected174 at risk EG0021 events1 affected88 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected194 at risk EG0012 events1 affected174 at risk EG0020 events0 affected88 at risk
Hypercapnia	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected194 at risk EG0011 events1 affected174 at risk EG0020 events0 affected88 at risk
Pneumonia aspiration	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected194 at risk EG0010 events0 affected174 at risk EG0020 events0 affected88 at risk
Pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events2 affected194 at risk EG0014 events4 affected174 at risk EG0020 events0 affected88 at risk
Bronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected194 at risk EG0010 events0 affected174 at risk EG0022 events1 affected88 at risk
Gastritis viral	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected194 at risk EG0010 events0 affected174 at risk EG0020 events0 affected88 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected194 at risk EG0011 events1 affected174 at risk EG0020 events0 affected88 at risk
Acute Myocardial Infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected194 at risk EG0012 events2 affected174 at risk EG0020 events0 affected88 at risk
Atrioventricular block complete	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected194 at risk EG0010 events0 affected174 at risk EG0021 events1 affected88 at risk
Myocardial Infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 events2 affected194 at risk EG0010 events0 affected174 at risk EG0020 events0 affected88 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected194 at risk EG0011 events1 affected174 at risk EG0020 events0 affected88 at risk
Angina unstable	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected194 at risk EG0011 events1 affected174 at risk EG0020 events0 affected88 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected194 at risk EG0010 events0 affected174 at risk EG0020 events0 affected88 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected194 at risk EG0011 events1 affected174 at risk EG0020 events0 affected88 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected194 at risk EG0010 events0 affected174 at risk EG0021 events1 affected88 at risk
Abdominal hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected194 at risk EG0011 events1 affected174 at risk EG0020 events0 affected88 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected194 at risk EG0010 events0 affected174 at risk EG0020 events0 affected88 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected194 at risk EG0011 events1 affected174 at risk EG0020 events0 affected88 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected194 at risk EG0010 events0 affected174 at risk EG0020 events0 affected88 at risk
Pulmonary contusion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected194 at risk EG0011 events1 affected174 at risk EG0020 events0 affected88 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected194 at risk EG0011 events1 affected174 at risk EG0020 events0 affected88 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected194 at risk EG0011 events1 affected174 at risk EG0020 events0 affected88 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected194 at risk EG0010 events0 affected174 at risk EG0020 events0 affected88 at risk
Squamous cell carcinoma of lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected194 at risk EG0011 events1 affected174 at risk EG0020 events0 affected88 at risk
Syncope	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 events2 affected194 at risk EG0010 events0 affected174 at risk EG0020 events0 affected88 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0002 events1 affected194 at risk EG0010 events0 affected174 at risk EG0020 events0 affected88 at risk
Non-cardiac chest pain	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected194 at risk EG0011 events1 affected174 at risk EG0020 events0 affected88 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected194 at risk EG0010 events0 affected174 at risk EG0020 events0 affected88 at risk
Intervertebral disc disorder	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected194 at risk EG0010 events0 affected174 at risk EG0020 events0 affected88 at risk
Anxiety	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 events1 affected194 at risk EG0010 events0 affected174 at risk EG0020 events0 affected88 at risk
Suicidal ideation	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 events0 affected194 at risk EG0011 events1 affected174 at risk EG0020 events0 affected88 at risk
Intermittent claudication	Vascular disorders	MedDRA	Systematic Assessment	EG0000 events0 affected194 at risk EG0011 events1 affected174 at risk EG0020 events0 affected88 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA	Systematic Assessment	EG0000 events0 affected194 at risk EG0010 events0 affected174 at risk EG0021 events1 affected88 at risk
Cataract	Eye disorders	MedDRA	Systematic Assessment	EG0001 events1 affected194 at risk EG0010 events0 affected174 at risk EG0020 events0 affected88 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected194 at risk EG0010 events0 affected174 at risk EG0020 events0 affected88 at risk
Pelvic pain	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 events1 affected194 at risk EG0010 events0 affected174 at risk EG0020 events0 affected88 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected194 at risk EG0011 events1 affected174 at risk EG0020 events0 affected88 at risk
Cellulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected194 at risk EG0010 events0 affected174 at risk EG0022 events1 affected88 at risk
Sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected194 at risk EG0010 events0 affected174 at risk EG0021 events1 affected88 at risk
Diverticulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected194 at risk EG0010 events0 affected174 at risk EG0020 events0 affected88 at risk
Gastroenteritis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected194 at risk EG0011 events1 affected174 at risk EG0020 events0 affected88 at risk
Pyelonephritis acute	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected194 at risk EG0010 events0 affected174 at risk EG0021 events1 affected88 at risk
Urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected194 at risk EG0010 events0 affected174 at risk EG0021 events1 affected88 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected194 at risk EG0011 events1 affected174 at risk EG0020 events0 affected88 at risk
Coronary artery disease	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected194 at risk EG0010 events0 affected174 at risk EG0021 events1 affected88 at risk
Respiratory fume inhalation disorder	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected194 at risk EG0010 events0 affected174 at risk EG0020 events0 affected88 at risk
Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected194 at risk EG0010 events0 affected174 at risk EG0020 events0 affected88 at risk
Colorectal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected194 at risk EG0010 events0 affected174 at risk EG0020 events0 affected88 at risk
Metastases to lung	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected194 at risk EG0010 events0 affected174 at risk EG0020 events0 affected88 at risk
Cerebral infarction	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected194 at risk EG0010 events0 affected174 at risk EG0020 events0 affected88 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected194 at risk EG0010 events0 affected174 at risk EG0021 events1 affected88 at risk
Electrocardiogram T wave invesion	Investigations	MedDRA	Systematic Assessment	EG0000 events0 affected194 at risk EG0011 events1 affected174 at risk EG0020 events0 affected88 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected194 at risk EG0010 events0 affected174 at risk EG0021 events1 affected88 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Upper Respiratory Tract Infection	Infections and infestations	MedDRA	Systematic Assessment	EG00024 events18 affected194 at risk EG00120 events17 affected174 at risk EG0026 events6 affected88 at risk
Viral Upper Respiratory Tract Infection	Infections and infestations	MedDRA	Systematic Assessment	EG00011 events9 affected194 at risk EG0016 events5 affected174 at risk EG0026 events6 affected88 at risk
Sinusitis	Infections and infestations	MedDra	Systematic Assessment	EG00014 events11 affected194 at risk EG0017 events6 affected174 at risk EG0023 events2 affected88 at risk
Urinary Tract Infection	Infections and infestations	MedDRA	Systematic Assessment	EG00010 events10 affected194 at risk EG0019 events6 affected174 at risk EG0024 events4 affected88 at risk
Bronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG00013 events12 affected194 at risk EG00110 events8 affected174 at risk EG0022 events2 affected88 at risk
Dysphonia	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0006 events6 affected194 at risk EG0012 events2 affected174 at risk EG0025 events5 affected88 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0004 events4 affected194 at risk EG0015 events5 affected174 at risk EG0025 events5 affected88 at risk
Muscle Spasms	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0006 events6 affected194 at risk EG0012 events2 affected174 at risk EG0025 events5 affected88 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0005 events5 affected194 at risk EG0019 events9 affected174 at risk EG0022 events2 affected88 at risk

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