Efficacy and Safety Study of PT009, PT008, and PT005 in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: BFF MDI 320/9.6 μg; BFF MDI 160/9.6 μg; BFF MDI 80/9.6 μg; BD MDI 320 μg; FF MDI 9.6 μg
Intervention description: Budesonide and formoterol fumarate metered dose inhaler (BFF MDI) 320/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID); Budesonide and formoterol fumarate metered dose inhaler (BFF MDI) 160/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID); Budesonide and formoterol fumarate metered dose inhaler (BFF MDI) 80/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID); Budesonide metered dose inhaler (BD MDI) 320 μg; PT008 administered as 2 inhalations, twice daily (BID); Formoterol fumarate metered dose inhaler (FF MDI) 9.6 μg; PT005 administered as 2 inhalations, twice daily (BID)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Masking description: Double Blind
Enrollment: 180.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Budesonide and formoterol inhalation aerosol

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