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

Chronic Obstructive Pulmonary Disease Clinical Trial

— PT009001  

Official title:

A Randomized, Double Blind, Chronic Dosing (28 Days), Four Period, Five Treatment, Incomplete Block, Multi Center, Crossover Study to Assess the Efficacy and Safety of PT009, PT008, and PT005 in Subjects With Moderate to Severe COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02196077
• Other study ID #: PT009001
• Status: Completed
• Phase: Phase 2
• Start date: August 1, 2014
• Est. completion date: March 1, 2015

Study information

• Verified date: May 2018
• Source: Pearl Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: March 1, 2015
• Est. primary completion date: March 1, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• BFF MDI 320/9.6 µg
Budesonide and formoterol fumarate metered dose inhaler (BFF MDI) 320/9.6 µg; PT009 administered as 2 inhalations, twice daily (BID)
• BFF MDI 160/9.6 µg
Budesonide and formoterol fumarate metered dose inhaler (BFF MDI) 160/9.6 µg; PT009 administered as 2 inhalations, twice daily (BID)
• BFF MDI 80/9.6 µg
Budesonide and formoterol fumarate metered dose inhaler (BFF MDI) 80/9.6 µg; PT009 administered as 2 inhalations, twice daily (BID)
• BD MDI 320 µg
Budesonide metered dose inhaler (BD MDI) 320 µg; PT008 administered as 2 inhalations, twice daily (BID)
• FF MDI 9.6 µg
Formoterol fumarate metered dose inhaler (FF MDI) 9.6 µg; PT005 administered as 2 inhalations, twice daily (BID)

Locations

Country	Name	City	State
United States	Pearl Investigative Site	Charlotte	North Carolina
United States	Pearl Investigative Site	Cincinnati	Ohio
United States	Pearl Investigative Site	Clearwater	Florida
United States	Pearl Investigative Site	Columbus	Ohio
United States	Pearl Investigative Site	Dublin	Ohio
United States	Pearl Investigative Site	Easley	South Carolina
United States	Pearl Investigative Site	Edina	Minnesota
United States	Pearl Investigative Site	Greenville	South Carolina
United States	Pearl Investigative Site	Medford	Oregon
United States	Pearl Investigative Site	Minneapolis	Minnesota
United States	Pearl Investigative Site	Panama City	Florida
United States	Pearl Investigative Site	Rolling Hills Estates	California
United States	Pearl Investigative Site	Saint Charles	Missouri
United States	Pearl Investigative Site	Spartanburg	South Carolina
United States	Pearl Investigative Site	Tampa	Florida
United States	Pearl Investigative Site	Winter Park	Florida
United States	Pearl Investigative Site	Woodbury	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Pearl Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change From Baseline in Morning Pre-dose Trough FEV1 Over 28 Days		Over 28 days
Secondary	Peak Change From Baseline in FEV1 (in Liters) Day 15		Day 15
Secondary	Peak Change From Baseline in FEV1 (in Liters) Day 29		Day 29
Secondary	Peak Change From Baseline in FEV1 on Day 1		Day 1
Secondary	Forced Vital Capacity (FVC) AUC0-12 on Day 29		Day 29
Secondary	Transition Dyspnea Index (TDI) Focal Score on Day 29	Min/Max Range of TDI scale -9 (major deterioration) to +9 (major improvement)	Day 29
Secondary	Change From Baseline in Average Daily Use of Rescue Ventolin HFA Over the Last Week of Treatment		Visit 12-13 (7 days)

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