Efficacy and Safety Study of PT009, PT008, and PT005 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

NCT02196077 | Completed Phase 2 Results FDA Drug

• 1 other identifier: PT009001
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 17

Brief Summary

This is a Phase IIb, randomized, double blind, chronic dosing (28 days), four period, five treatment, incomplete block, crossover design in subjects with moderate to severe COPD. The overall objective is to demonstrate that the combination of budesonide (BD; PT008) and formoterol fumarate (FF; PT005) in a metered-dose inhaler (MDI); (BFF MDI; PT009) provides benefit on lung function compared with BD MDI in subjects with moderate to severe COPD.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Budesonide and formoterol inhalation aerosol

Outcome Measures

Primary Outcomes (1)

• FEV1 AUC0-12 on Day 29

  Change from Baseline in forced expiratory volume in 1 second (FEV1) area under the curve from 0 to 12 hours (AUC0-12)

  Day 29

Secondary Outcomes (7)

• Change From Baseline in Morning Pre-dose Trough FEV1 Over 28 Days

  Over 28 days

• Peak Change From Baseline in FEV1 (in Liters) Day 15

  Day 15

• Peak Change From Baseline in FEV1 (in Liters) Day 29

  Day 29

• Peak Change From Baseline in FEV1 on Day 1

  Day 1

• Forced Vital Capacity (FVC) AUC0-12 on Day 29

  Day 29

Study Arms (5)

BFF MDI 320/9.6 μg

EXPERIMENTAL

Budesonide and formoterol fumarate metered dose inhaler (BFF MDI) 320/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID)

Drug: BFF MDI 320/9.6 μg

BFF MDI 160/9.6 μg

EXPERIMENTAL

Budesonide and formoterol fumarate metered dose inhaler (BFF MDI)160/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID)

Drug: BFF MDI 160/9.6 μg

BFF MDI 80/9.6 μg

EXPERIMENTAL

Budesonide and formoterol fumarate metered dose inhaler (BFF MDI) 80/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID)

Drug: BFF MDI 80/9.6 μg

BD MDI 320 μg

EXPERIMENTAL

Budesonide metered dose inhaler (BD MDI) 320 μg; PT008 administered as 2 inhalations, twice daily (BID)

Drug: BD MDI 320 μg

FF MDI 9.6 μg

EXPERIMENTAL

Formoterol fumarate metered dose inhaler (FF MDI) 9.6 μg; PT005 administered as 2 inhalations, twice daily (BID)

Drug: FF MDI 9.6 μg

Interventions

BFF MDI 320/9.6 μg DRUG

Budesonide and formoterol fumarate metered dose inhaler (BFF MDI) 320/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID)

BFF MDI 320/9.6 μg

BFF MDI 160/9.6 μg DRUG

Budesonide and formoterol fumarate metered dose inhaler (BFF MDI) 160/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID)

BFF MDI 160/9.6 μg

BFF MDI 80/9.6 μg DRUG

Budesonide and formoterol fumarate metered dose inhaler (BFF MDI) 80/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID)

BFF MDI 80/9.6 μg

BD MDI 320 μg DRUG

Budesonide metered dose inhaler (BD MDI) 320 μg; PT008 administered as 2 inhalations, twice daily (BID)

BD MDI 320 μg

FF MDI 9.6 μg DRUG

Formoterol fumarate metered dose inhaler (FF MDI) 9.6 μg; PT005 administered as 2 inhalations, twice daily (BID)

FF MDI 9.6 μg

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed Consent Form (ICF) prior to any study related procedures
• COPD Diagnosis: Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS)
• Tobacco Use: Current or former smokers with a history of at least 10 pack years of cigarette smoking
• Women of non-childbearing potential or medically acceptable contraception for women of child-bearing potential and males with female partners of childbearing potential
• Severity of Disease: Subjects with an established clinical history of COPD and severity defined as: FEV1/forced vital capacity (FVC) ratio of \<0.70; At Screening (Visit 1a/b), post bronchodilator FEV1 must be \<80% predicted normal value, calculated using NHANES III (Third National Health and Nutrition Examination Survey) reference equations; the measured FEV1 must also be ≥30% of predicted normal value; at Visit 2, the average of the 60 minutes and 30 minutes pre dose FEV1 assessments must be \<80% predicted normal value calculated using NHANES III reference equations
• Screening clinical laboratory tests must be acceptable to the Investigator
• Screening ECG must be acceptable to the Investigator
• Chest x ray or computerized tomography (CT) scan within 6 months prior to Visit 1a must be acceptable to the Investigator.

You may not qualify if:

• Significant diseases other than COPD, ie., disease or condition which, in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study
• Pregnancy, nursing female subjects, or subjects trying to conceive, or not using medically acceptable form of contraception
• Asthma: Subjects who have a primary diagnosis of asthma (Note: Subjects with a prior history of asthma are eligible if COPD is currently their primary diagnosis).
• Alpha 1 Antitrypsin Deficiency: Subjects who have alpha 1 antitrypsin deficiency as the cause of COPD -Active pulmonary disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, primary pulmonary hypertension, interstitial lung disease, and uncontrolled sleep apnea (ie., in the opinion of the Investigator severity of the disorder would impact the conduct of the study)-
• Clinically significant neurologic, cardiovascular, hepatic, renal, endocrinologic, pulmonary, hematological, psychiatric, or other medical illness that would interfere with participation in this study
• Poorly Controlled COPD
• History of ECG abnormalities
• Cancer not in complete remission for at least 5 years
• Clinically significant, symptomatic prostatic hypertrophy
• Male subjects with a trans-urethral resection of the prostate or full resection of the prostate within 6 months prior to Screening
• Clinically significant bladder neck obstruction or urinary retention
• Inadequately treated glaucoma
• History of an allergic reaction or hypersensitivity to any drug or to any component of the formulations used in this study

Sponsors & Collaborators

• Pearl Therapeutics, Inc.: lead

Study Sites (17)

Pearl Investigative Site

Rolling Hills Estates, California, United States

Location

Pearl Investigative Site

Clearwater, Florida, United States

Location

Pearl Investigative Site

Panama City, Florida, United States

Location

Pearl Investigative Site

Tampa, Florida, United States

Location

Pearl Investigative Site

Winter Park, Florida, United States

Location

Pearl Investigative Site

Edina, Minnesota, United States

Location

Pearl Investigative Site

Minneapolis, Minnesota, United States

Location

Pearl Investigative Site

Woodbury, Minnesota, United States

Location

Pearl Investigative Site

Saint Charles, Missouri, United States

Location

Pearl Investigative Site

Charlotte, North Carolina, United States

Location

Pearl Investigative Site

Cincinnati, Ohio, United States

Location

Pearl Investigative Site

Columbus, Ohio, United States

Location

Pearl Investigative Site

Dublin, Ohio, United States

Location

Pearl Investigative Site

Medford, Oregon, United States

Location

Pearl Investigative Site

Easley, South Carolina, United States

Location

Pearl Investigative Site

Greenville, South Carolina, United States

Location

Pearl Investigative Site

Spartanburg, South Carolina, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Paul Dorinsky, MD, FCCP
• Organization: Pearl Therapeutics Inc.

pdorinsky@pearltherapeutics.com

650-305-2600

Study Officials

• Shahid Siddiqui, MD, MHSA

  Pearl Therapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double Blind
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2014
• First Posted: July 21, 2014
• Study Start: August 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: June 20, 2018
• Results First Posted: May 9, 2017

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will share

Locations

US (17)