Clinical trial NCT02196077: Efficacy and Safety Study of PT009, PT008, and PT005 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Budesonide and formoterol inhalation aerosol
Lead sponsor: Pearl Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2014-07-21
Enrollment: 180
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: FEV1 AUC0-12 on Day 29
timeFrame: Day 29
Secondary outcomes:
measure: Change From Baseline in Morning Pre-dose Trough FEV1 Over 28 Days
timeFrame: Over 28 days
measure: Peak Change From Baseline in FEV1 (in Liters) Day 15
timeFrame: Day 15
measure: Peak Change From Baseline in FEV1 (in Liters) Day 29
timeFrame: Day 29
measure: Peak Change From Baseline in FEV1 on Day 1
timeFrame: Day 1
measure: Forced Vital Capacity (FVC) AUC0-12 on Day 29
timeFrame: Day 29
measure: Transition Dyspnea Index (TDI) Focal Score on Day 29
timeFrame: Day 29
measure: Change From Baseline in Average Daily Use of Rescue Ventolin HFA Over the Last Week of Treatment
timeFrame: Visit 12-13 (7 days)
Other outcomes:
Locations:
city: Rolling Hills Estates
country: United States
facility: Pearl Investigative Site
state: California
city: Clearwater
country: United States
facility: Pearl Investigative Site
state: Florida
city: Panama City
country: United States
facility: Pearl Investigative Site
state: Florida
city: Tampa
country: United States
facility: Pearl Investigative Site
state: Florida
city: Winter Park
country: United States
facility: Pearl Investigative Site
state: Florida
city: Edina
country: United States
facility: Pearl Investigative Site
state: Minnesota
city: Minneapolis
country: United States
facility: Pearl Investigative Site
state: Minnesota
city: Woodbury
country: United States
facility: Pearl Investigative Site
state: Minnesota
city: Saint Charles
country: United States
facility: Pearl Investigative Site
state: Missouri
city: Charlotte
country: United States
facility: Pearl Investigative Site
state: North Carolina
city: Cincinnati
country: United States
facility: Pearl Investigative Site
state: Ohio
city: Columbus
country: United States
facility: Pearl Investigative Site
state: Ohio
city: Dublin
country: United States
facility: Pearl Investigative Site
state: Ohio
city: Medford
country: United States
facility: Pearl Investigative Site
state: Oregon
city: Easley
country: United States
facility: Pearl Investigative Site
state: South Carolina
city: Greenville
country: United States
facility: Pearl Investigative Site
state: South Carolina
city: Spartanburg
country: United States
facility: Pearl Investigative Site
state: South Carolina
Study officials:
affiliation: Pearl Therapeutics, Inc.
name: Shahid Siddiqui, MD, MHSA
role: STUDY_DIRECTOR
References: