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

Study identifier:PT010008

ClinicalTrials.gov identifier:NCT02536508

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

A Randomized, Double-Blind, Parallel-Group, 52-Week, Chronic-Dosing, Multi-Center Study to Assess the Safety and Tolerability of PT010, PT009 and PT003 in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Medical condition

COPD

Phase

Phase 3

Healthy volunteers

Study drug

BGF MDI 320/14.4/9.6 μg, GFF MDI 14.4/9.6 μg, BFF MDI 320/9.6 μg

Sex

All

Actual Enrollment

627

Study type

Interventional

Age

40 Years - 80 Years

Date

Study Start Date: 10 Aug 2015

Primary Completion Date: 12 Sept 2017

Study Completion Date: 12 Sept 2017

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 Jan 2021 by Pearl Therapeutics, Inc.

Collaborators

Inclusion and exclusion criteria

Location

Research Site

Morgantown, WV, United States, 26505

Location

Research Site

Miami, FL, United States, 33186

Location

Research Site

Columbus, OH, United States, 43213

Location

Research Site

Union, SC, United States, 29379

Location

Research Site

Hendersonville, NC, United States, 28739

Location

Research Site

Seneca, SC, United States, 29678

Location

Research Site

Greenville, SC, United States, 29615

Location

Research Site

Rock Hill, SC, United States, 29732

Arms	Assigned Interventions
Experimental: BGF MDI (PT010) 320/14.4/9.6 μg Budesonide, Glycopyrronium, and Formoterol Fumarate (BGF) metered dose inhaler (MDI) (PT010, BGF MDI)	Drug: BGF MDI 320/14.4/9.6 μg Budesonide, Glycopyrronium, and Formoterol Fumarate Other Name: BGF MDI
Experimental: GFF MDI (PT003) 14.4/9.6 μg Glycopyrronium and Formoterol Fumarate (GFF) metered dose inhaler (MDI) (PT003, GFF MDI)	Drug: GFF MDI 14.4/9.6 μg Glycopyrronium and Formoterol Fumarate Other Name: GFF MDI
Experimental: BFF MDI (PT009) 320/9.6 μg Budesonide and Formoterol Fumarate (BFF) metered dose inhaler (MDI) (PT009, BFF MDI)	Drug: BFF MDI 320/9.6 μg Budesonide and Formoterol Fumarate Other Name: BFF MDI

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study randomized subjects at 69 sites in the United States from September 2015 to September 2017. The entire study period was scheduled to take up to approximately 58 weeks for each individual subject from the time of screening through the follow-up period.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were randomized in a 2:2:1 scheme (BGF MDI:GFF MDI:BFF MDI).

Reporting Groups

	Description
BGF MDI 320/14.4/9.6 ug	Budesonide Gylcopyrronium and Formoterol Fumarate Inhalation Aerosol 320/14.4/9.6 ug
GFF MDI 14.4/9.6 ug	Glycopyrronium and Formoterol Fumarate Inhalation Aerosol 14.4/9.6 ug
BFF MDI 320/9.6 ug	Budesonide and Formoterol Fumarate Inhalation Aerosol 320/9.6 ug

Participant Flow: Overall Study

	BGF MDI 320/14.4/9.6 ug	GFF MDI 14.4/9.6 ug	BFF MDI 320/9.6 ug
STARTED	194	174	88
COMPLETED	142	130	65
NOT COMPLETED	52	44	23
Withdrawal by Subject	18	13	7
Adverse Event	14	13	6
Lost to Follow-up	12	4	0
Lack of Efficacy	3	5	4
Protocol Discontinuation Criteria	3	2	2
Physician Decision	0	4	2
Major Protocol Deviation	2	2	2
Administrative Reasons	0	1	0

Baseline Characteristics

Analysis Population Description -- Explanation of how the number of participants for analysis was determined.

The Safety Population included only subjects who signed ICF for Study PT010008 and received any amount of study drug (other than Symbicort).

Reporting Groups

	Description
BGF MDI 320/14.4/9.6 ug	Budesonide Gylcopyrronium and Formoterol Fumarate Inhalation Aerosol 320/14.4/9.6 ug
GFF MDI 14.4/9.6 ug	Glycopyrronium and Formoterol Fumarate Inhalation Aerosol 14.4/9.6 ug
BFF MDI 320/9.6 ug	Budesonide and Formoterol Fumarate Inhalation Aerosol 320/9.6 ug

Baseline Measures

	BGF MDI 320/14.4/9.6 ug	GFF MDI 14.4/9.6 ug	BFF MDI 320/9.6 ug	Total
Number of Participants [units: Participants]	194	174	88	456
Age Continuous [units: Years] Mean ± Standard Deviation	62.6 ± 7.9	62.4 ± 7.8	64.0 ± 7.2	62.8 ± 7.7
Sex: Female, Male [units: ]
Female	92	87	35	214
Male	102	87	53	242
Ethnicity (NIH/OMB) [units: ]
Hispanic or Latino	9	5	6	20
Not Hispanic or Latino	185	169	82	436
Unknown or Not Reported	0	0	0	0
Race/Ethnicity, Customized [units: Participants]
Black	13	17	9	39
White	179	156	79	414
Asian	0	1	0	1
Other	2	0	0	2

Outcome Measures

1. Primary Outcome Measure: Percent Change from Baseline in BMD of the Lumbar Spine [ Time Frame: at week 52 ]

Measure Type	Primary
Measure Name	Percent Change from Baseline in BMD of the Lumbar Spine
Measure Description	Percent change from baseline in BMD of the lumbar spine T-Score at Week 52.
Time Frame	at week 52
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
BGF MDI 320/14.4/9.6 ug	Budesonide Gylcopyrronium and Formoterol Fumarate Inhalation Aerosol 320/14.4/9.6 ug
GFF MDI 14.4/9.6 ug	Glycopyrronium and Formoterol Fumarate Inhalation Aerosol 14.4/9.6 ug
BFF MDI 320/9.6 ug	Budesonide and Formoterol Fumarate Inhalation Aerosol 320/9.6 ug

Measured Values

	BGF MDI 320/14.4/9.6 ug	GFF MDI 14.4/9.6 ug	BFF MDI 320/9.6 ug
Number of Participants Analyzed [units:participants]	128	123	57
Percent Change from Baseline in BMD of the Lumbar Spine [units: Percentage] Least Squares Mean (95% Confidence Interval)	-0.093 (-0.739 to 0.557)	0.379 (-0.28 to 1.042)	-0.120 (-1.087 to 0.857)

No statistical analysis provided for Percent Change from Baseline in BMD of the Lumbar Spine

2. Primary Outcome Measure: Change from baseline in the LOCS III (P) score at Week 52 [ Time Frame: at week 52 ]

Measure Type	Primary
Measure Name	Change from baseline in the LOCS III (P) score at Week 52
Measure Description	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.
Time Frame	at week 52
Safety Issue?	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
BGF MDI 320/14.4/9.6 ug	Budesonide Gylcopyrronium and Formoterol Fumarate Inhalation Aerosol 320/14.4/9.6 ug
GFF MDI 14.4/9.6 ug	Glycopyrronium and Formoterol Fumarate Inhalation Aerosol 14.4/9.6 ug
BFF MDI 320/9.6 ug	Budesonide and Formoterol Fumarate Inhalation Aerosol 320/9.6 ug

Measured Values

	BGF MDI 320/14.4/9.6 ug	GFF MDI 14.4/9.6 ug	BFF MDI 320/9.6 ug
Number of Participants Analyzed [units:participants]	132	125	54
Change from baseline in the LOCS III (P) score at Week 52 [units: P-Score] Least Squares Mean (95% Confidence Interval)	0.153 (0.079 to 0.227)	.026 (-0.055 to 0.106)	0.022 (-0.090 to 0.135)

No statistical analysis provided for Change from baseline in the LOCS III (P) score at Week 52

Serious Adverse Events

Time Frame	Adverse events were collected from the time of administration of the first dose of study drug to the time of the final follow-up telephone call. Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call up to approximately 54 weeks.
Additional Description	The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug.

Reporting Groups

	Description
BGF MDI 320/14.4/9.6 ug	Budesonide Gylcopyrronium and Formoterol Fumarate Inhalation Aerosol 320/14.4/9.6 ug
GFF MDI 14.4/9.6 ug	Glycopyrronium and Formoterol Fumarate Inhalation Aerosol 14.4/9.6 ug
BFF MDI 320/9.6 ug	Budesonide and Formoterol Fumarate Inhalation Aerosol 320/9.6 ug

Serious Adverse Events

BGF MDI 320/14.4/9.6 ug

GFF MDI 14.4/9.6 ug

BFF MDI 320/9.6 ug

Total, serious adverse events

# participants affected / at risk

33/194 (17.01%)

22/174 (12.64%)

7/88 (7.95%)

Respiratory, thoracic and mediastinal disorders

Chronic Pulmonary Obstructive Disease¹,^†

# participants affected / at risk

12/194 (6.19%)

9/174 (5.17%)

2/88 (2.27%)

# events

Respiratory, thoracic and mediastinal disorders

Acute Respiratory Failure¹,^†

# participants affected / at risk

0/194 (0.00%)

2/174 (1.15%)

0/88 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Respiratory Failure¹,^†

# participants affected / at risk

1/194 (0.52%)

0/174 (0.00%)

1/88 (1.14%)

# events

Respiratory, thoracic and mediastinal disorders

Hypoxia¹,^†

# participants affected / at risk

0/194 (0.00%)

1/174 (0.57%)

0/88 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Hypercapnia¹,^†

# participants affected / at risk

0/194 (0.00%)

1/174 (0.57%)

0/88 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Pneumonia aspiration¹,^†

# participants affected / at risk

1/194 (0.52%)

0/174 (0.00%)

0/88 (0.00%)

# events

Infections and infestations

Pneumonia¹,^†

# participants affected / at risk

2/194 (1.03%)

4/174 (2.30%)

0/88 (0.00%)

# events

Infections and infestations

Bronchitis¹,^†

# participants affected / at risk

1/194 (0.52%)

0/174 (0.00%)

1/88 (1.14%)

# events

Infections and infestations

Gastritis viral¹,^†

# participants affected / at risk

1/194 (0.52%)

0/174 (0.00%)

0/88 (0.00%)

# events

Infections and infestations

Upper respiratory tract infection¹,^†

# participants affected / at risk

0/194 (0.00%)

1/174 (0.57%)

0/88 (0.00%)

# events

Cardiac disorders

Acute Myocardial Infarction¹,^†

# participants affected / at risk

0/194 (0.00%)

2/174 (1.15%)

0/88 (0.00%)

# events

Cardiac disorders

Atrioventricular block complete¹,^†

# participants affected / at risk

1/194 (0.52%)

0/174 (0.00%)

1/88 (1.14%)

# events

Cardiac disorders

Myocardial Infarction¹,^†

# participants affected / at risk

2/194 (1.03%)

0/174 (0.00%)

0/88 (0.00%)

# events

Cardiac disorders

Acute coronary syndrome¹,^†

# participants affected / at risk

0/194 (0.00%)

1/174 (0.57%)

0/88 (0.00%)

# events

Cardiac disorders

Angina unstable¹,^†

# participants affected / at risk

0/194 (0.00%)

1/174 (0.57%)

0/88 (0.00%)

# events

Cardiac disorders

Coronary artery occlusion¹,^†

# participants affected / at risk

1/194 (0.52%)

0/174 (0.00%)

0/88 (0.00%)

# events

Cardiac disorders

Myocardial ischaemia¹,^†

# participants affected / at risk

0/194 (0.00%)

1/174 (0.57%)

0/88 (0.00%)

# events

Cardiac disorders

Supraventricular tachycardia¹,^†

# participants affected / at risk

0/194 (0.00%)

0/174 (0.00%)

1/88 (1.14%)

# events

Gastrointestinal disorders

Abdominal hernia¹,^†

# participants affected / at risk

0/194 (0.00%)

1/174 (0.57%)

0/88 (0.00%)

# events

Gastrointestinal disorders

Gastrointestinal haemorrhage¹,^†

# participants affected / at risk

1/194 (0.52%)

0/174 (0.00%)

0/88 (0.00%)

# events

Gastrointestinal disorders

Inguinal hernia¹,^†

# participants affected / at risk

0/194 (0.00%)

1/174 (0.57%)

0/88 (0.00%)

# events

Injury, poisoning and procedural complications

Hip fracture¹,^†

# participants affected / at risk

1/194 (0.52%)

0/174 (0.00%)

0/88 (0.00%)

# events

Injury, poisoning and procedural complications

Pulmonary contusion¹,^†

# participants affected / at risk

0/194 (0.00%)

1/174 (0.57%)

0/88 (0.00%)

# events

Injury, poisoning and procedural complications

Rib fracture¹,^†

# participants affected / at risk

0/194 (0.00%)

1/174 (0.57%)

0/88 (0.00%)

# events

Injury, poisoning and procedural complications

Road traffic accident¹,^†

# participants affected / at risk

0/194 (0.00%)

1/174 (0.57%)

0/88 (0.00%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Lung adenocarcinoma¹,^†

# participants affected / at risk

1/194 (0.52%)

0/174 (0.00%)

0/88 (0.00%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Squamous cell carcinoma of lung¹,^†

# participants affected / at risk

0/194 (0.00%)

1/174 (0.57%)

0/88 (0.00%)

# events

Nervous system disorders

Syncope¹,^†

# participants affected / at risk

2/194 (1.03%)

0/174 (0.00%)

0/88 (0.00%)

# events

Renal and urinary disorders

Nephrolithiasis¹,^†

# participants affected / at risk

1/194 (0.52%)

0/174 (0.00%)

0/88 (0.00%)

# events

General disorders

Non-cardiac chest pain¹,^†

# participants affected / at risk

1/194 (0.52%)

1/174 (0.57%)

0/88 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Cervical spinal stenosis¹,^†

# participants affected / at risk

1/194 (0.52%)

0/174 (0.00%)

0/88 (0.00%)

# events

Musculoskeletal and connective tissue disorders

Intervertebral disc disorder¹,^†

# participants affected / at risk

1/194 (0.52%)

0/174 (0.00%)

0/88 (0.00%)

# events

Psychiatric disorders

Anxiety¹,^†

# participants affected / at risk

1/194 (0.52%)

0/174 (0.00%)

0/88 (0.00%)

# events

Psychiatric disorders

Suicidal ideation¹,^†

# participants affected / at risk

0/194 (0.00%)

1/174 (0.57%)

0/88 (0.00%)

# events

Vascular disorders

Intermittent claudication¹,^†

# participants affected / at risk

0/194 (0.00%)

1/174 (0.57%)

0/88 (0.00%)

# events

Vascular disorders

Peripheral vascular disorder¹,^†

# participants affected / at risk

0/194 (0.00%)

0/174 (0.00%)

1/88 (1.14%)

# events

Eye disorders

Cataract¹,^†

# participants affected / at risk

1/194 (0.52%)

0/174 (0.00%)

0/88 (0.00%)

# events

Hepatobiliary disorders

Cholecystitis acute¹,^†

# participants affected / at risk

1/194 (0.52%)

0/174 (0.00%)

0/88 (0.00%)

# events

Reproductive system and breast disorders

Pelvic pain¹,^†

# participants affected / at risk

1/194 (0.52%)

0/174 (0.00%)

0/88 (0.00%)

# events

Gastrointestinal disorders

Pancreatitis acute¹,^†

# participants affected / at risk

1/194 (0.52%)

1/174 (0.57%)

0/88 (0.00%)

# events

Infections and infestations

Cellulitis¹,^†

# participants affected / at risk

1/194 (0.52%)

0/174 (0.00%)

1/88 (1.14%)

# events

Infections and infestations

Sepsis¹,^†

# participants affected / at risk

1/194 (0.52%)

0/174 (0.00%)

1/88 (1.14%)

# events

Infections and infestations

Diverticulitis¹,^†

# participants affected / at risk

1/194 (0.52%)

0/174 (0.00%)

0/88 (0.00%)

# events

Infections and infestations

Gastroenteritis¹,^†

# participants affected / at risk

0/194 (0.00%)

1/174 (0.57%)

0/88 (0.00%)

# events

Infections and infestations

Pyelonephritis acute¹,^†

# participants affected / at risk

0/194 (0.00%)

0/174 (0.00%)

1/88 (1.14%)

# events

Infections and infestations

Urinary tract infection¹,^†

# participants affected / at risk

0/194 (0.00%)

0/174 (0.00%)

1/88 (1.14%)

# events

Cardiac disorders

Cardiac failure congestive¹,^†

# participants affected / at risk

0/194 (0.00%)

1/174 (0.57%)

0/88 (0.00%)

# events

Cardiac disorders

Coronary artery disease¹,^†

# participants affected / at risk

0/194 (0.00%)

0/174 (0.00%)

1/88 (1.14%)

# events

Injury, poisoning and procedural complications

Respiratory fume inhalation disorder¹,^†

# participants affected / at risk

1/194 (0.52%)

0/174 (0.00%)

0/88 (0.00%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Adenocarcinoma¹,^†

# participants affected / at risk

1/194 (0.52%)

0/174 (0.00%)

0/88 (0.00%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Colorectal cancer metastatic¹,^†

# participants affected / at risk

1/194 (0.52%)

0/174 (0.00%)

0/88 (0.00%)

# events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Metastases to lung¹,^†

# participants affected / at risk

1/194 (0.52%)

0/174 (0.00%)

0/88 (0.00%)

# events

Nervous system disorders

Cerebral infarction¹,^†

# participants affected / at risk

1/194 (0.52%)

0/174 (0.00%)

0/88 (0.00%)

# events

Renal and urinary disorders

Acute kidney injury¹,^†

# participants affected / at risk

0/194 (0.00%)

0/174 (0.00%)

1/88 (1.14%)

# events

Investigations

Electrocardiogram T wave invesion¹,^†

# participants affected / at risk

0/194 (0.00%)

1/174 (0.57%)

0/88 (0.00%)

# events

Respiratory, thoracic and mediastinal disorders

Pulmonary mass¹,^†

# participants affected / at risk

0/194 (0.00%)

0/174 (0.00%)

1/88 (1.14%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA

Other Adverse Events

Time Frame	Adverse events were collected from the time of administration of the first dose of study drug to the time of the final follow-up telephone call. Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call up to approximately 54 weeks.
Additional Description	The Safety Population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study drug.

Frequency Threshold

Threshold above which other adverse events are reported	5.0%

Reporting Groups

	Description
BGF MDI 320/14.4/9.6 ug	Budesonide Gylcopyrronium and Formoterol Fumarate Inhalation Aerosol 320/14.4/9.6 ug
GFF MDI 14.4/9.6 ug	Glycopyrronium and Formoterol Fumarate Inhalation Aerosol 14.4/9.6 ug
BFF MDI 320/9.6 ug	Budesonide and Formoterol Fumarate Inhalation Aerosol 320/9.6 ug

Other Adverse Events

BGF MDI 320/14.4/9.6 ug

GFF MDI 14.4/9.6 ug

BFF MDI 320/9.6 ug

Total, other (not including serious) adverse events

# participants affected / at risk

62/194 (31.96%)

51/174 (29.31%)

30/88 (34.09%)

Infections and infestations

Upper Respiratory Tract Infection¹,^†

# participants affected / at risk

18/194 (9.28%)

17/174 (9.77%)

6/88 (6.82%)

# events

Infections and infestations

Viral Upper Respiratory Tract Infection¹,^†

# participants affected / at risk

9/194 (4.64%)

5/174 (2.87%)

6/88 (6.82%)

# events

Infections and infestations

Sinusitis²,^†

# participants affected / at risk

11/194 (5.67%)

6/174 (3.45%)

2/88 (2.27%)

# events

Infections and infestations

Urinary Tract Infection¹,^†

# participants affected / at risk

10/194 (5.15%)

6/174 (3.45%)

4/88 (4.55%)

# events

Infections and infestations

Bronchitis¹,^†

# participants affected / at risk

12/194 (6.19%)

8/174 (4.60%)

2/88 (2.27%)

# events

Respiratory, thoracic and mediastinal disorders

Dysphonia¹,^†

# participants affected / at risk

6/194 (3.09%)

2/174 (1.15%)

5/88 (5.68%)

# events

Respiratory, thoracic and mediastinal disorders

Dyspnoea¹,^†

# participants affected / at risk

4/194 (2.06%)

5/174 (2.87%)

5/88 (5.68%)

# events

Musculoskeletal and connective tissue disorders

Muscle Spasms¹,^†

# participants affected / at risk

6/194 (3.09%)

2/174 (1.15%)

5/88 (5.68%)

# events

Gastrointestinal disorders

Diarrhoea¹,^†

# participants affected / at risk

5/194 (2.58%)

9/174 (5.17%)

2/88 (2.27%)

# events

†	Events were collected by systematic assessment
1	Term from vocabulary, MedDRA
2	Term from vocabulary, MedDra

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days . The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Drafts of any and all publications or presentations of this study must be submitted at least 30 days prior to submission for publication or presentation to Pearl Therapeutics for review, approval, and to ensure consistency. Pearl Therapeutics has the right to request appropriate modification to correct facts and to represent it's opinions, or the opinions of the publication committee, if these differ with the proposed publication.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact

Name/Title:	Pearl Therapeutics, Inc.
Organization:	Pearl Therapeutics, Inc.
Phone	1-877-240-9479
E-mail:	[email protected]

Documents available

PT010008-01_Protocol_Version_2.0_REDACTED.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Investigators

Principal Investigator

Colin Reisner

Pearl Therapeutics

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

Research Site

PT010008-01_Protocol_Version_2.0_REDACTED.pdf

Trial Results Summaries