None listed
Conditions
Brief summary
The primary purpose of this study is to compare the safety and improvement in lung function in patients with chronic obstructive pulmonary disease (COPD) following administration of inhaled PT005 to inhaled placebo. The safety and improvement in lung function will also be compared to a known and approved inhaled bronchodilator (Foradil Aerolizer) for the treatment of patients with chronic obstructive pulmonary disease (COPD). The primary hypothesis is that inhaled PT005 will be safe, well tolerated and will demonstrate greater improvement in lung function compared to placebo, and these improvements will be comparable to Foradil Aerolizer.
Interventions
Foradil Aerolizer (12 micrograms formoterol fumarate dry powder for inhalation) is an inhaled long acting bronchodilator medication that is indicated for asthma and chronic obstructive pulmonary disease (COPD). PT005 is an inhaled long acting bronchodilator. The design uses ascending doses of PT005 (3, 6 and 12 micrograms) with a full crossover. There are 5 single days of treatment with a minimum of 3 days and maximum of 10 days between treatments. The Foradil Aerolizer is administered as
Foradil Aerolizer (12 micrograms formoterol fumarate dry powder for inhalation) is an inhaled long acting bronchodilator medication that is indicated for asthma and chronic obstructive pulmonary disease (COPD). PT005 is an inhaled long acting bronchodilator. The design uses ascending doses of PT005 (3, 6 and 12 micrograms) with a full crossover. There are 5 single days of treatment with a minimum of 3 days and maximum of 10 days between treatments. The Foradil Aerolizer is administered as per the instructions for use with one inhalation.
Sponsors
Pearl Therapeutics Inc.
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Established clinical history of chronic obstructive pulmonary disease (COPD) in accordance with the American Thoracic Society/ European Respiratory Society criteria 2. Current or prior history of at least 10 pack-years of cigarette smoking. It should be noted that number of pack years = (number of cigarettes per day/ 20) X number of years smoked. For example, 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years. Previous smokers are defined as those who have stopped smoking for at least 6 months prior to visit 1; 3. A measured post-salbutamol FEV1/FVC ratio of less than or equal to 0.70 at Visit 1 (Screening); 4. A measured post-salbutamol FEV1 greater than or equal to 40% and less than or equal to 80% of predicted normal values calculated using National Health and Nutrition Examination Survey (NHANES) III references equations at Visit 1 (Screening); 5. Demonstrated reversiblity to a short acting beta agonist (>12% and >150 ml improvement in baseline FEV1 30 minutes following administration of 4 puffs of salbutamol MDI, or > 200 ml improvement in baseline FEV1, 30 minutes following administration of 4 puffs of salbutamol metered dose inhaler (MDI)
Exclusion criteria
1. Primary diagnosis of asthma. Patients with a prior history of asthma are eligible if chronic obstructive pulmonary disease (COPD) is currently their primary diagnosis; 2. Active tuberculosis, lung cancer, bronchietasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung disease or other active pulmonary disease; 3. Lung volume reduction surgery at any time in the past; 4. Chest X-ray [or Computed Tomography (CT) scan] reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD; 5. Hospitalization due to poorly controlled COPD within 24 weeks of the screening visit; 6. Poorly controlled COPD, defined as the occurrence of any of the following in the 6 weeks prior to Visit 1 or between Visit 1 and Visit 2: a. Acute worsening of COPD that is managed with corticosteroids or antibiotics; or b. Acute worsening of COPD that requires treatment prescribed by a physician; 7. Clinically significant medical conditions including but not limited to cardiovascular, neurological, psychiatric, renal, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or haematological abnormalities that are uncontrolled; 8. Lower respiratory tract infections which requires the use of antibiotics within 6 weeks prior to Visit 1; 9. Abnormal and clinically significant 12-lead ECG that results in an active medical condition; 10. Treatment with tricyclic antidepressants, monoamine oxidase (MAO) inhibitors, beta-adrenergic antagonists, anticonvulsants (barbiturates, hydantoins and carbamazepine) or phenothiazines would be ineligible for the study; 11. Non-compliance with study procedures, including an inability to abstain from smoking throughout each test day.
Outcome results
None listed