None listed
Conditions
Interventions
Investigational materials will be provided by Pearl, as shown below:
BFF MDI 320/9.6 µg (160/4.8 µg per actuation)
BFF MDI 160/9.6 µg (80/4.8 µg per actuation)
FF MDI 9.6 µg (4.8 µg per actua
Sponsors
Pearl Therapeutics Inc.,
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Each subject must meet the following criteria, in relationship to Visit 1, unless otherwise noted, to be enrolled in this study: 1.Give their signed written informed consent to participate 2.Are at least 40 years of age and no older than 80 years 3.COPD Diagnosis: subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS) [Celli, 2004] or by locally applicable guidelines, e.g., JRS Guidelines [JRS, 2013] characterized by progressive airflow limitation associated with an abnormal inflammatory response of the lungs to noxious particles or gases, primarily caused by cigarette smoking 4. COPD Severity: subjects with established COPD clinical history and who are symptomatic (CAT ≥ 10) and severity defined and calculated using NHANES III reference equations
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following criteria, in relationship to Visit 1, will be excluded from the study unless otherwise stated. 1.Respiratory a.Current diagnosis of asthma, in the opinion of the Investigator b.COPD due to α1-Antitrypsin Deficiency c.Sleep apnea that, in the opinion of the Investigator, is uncontrolled d.Other Respiratory Disorders: known active tuberculosis, lung cancer, cystic fibrosis, significant bronchiectasis (high resolution CT evidence of bronchiectasis that causes repeated acute exacerbations), sarcoidosis, idiopathic interstitial pulmonary fibrosis, primary pulmonary hypertension, or pulmonary thromboembolic disease Note: allergic rhinitis is not exclusionary)
Countries
Argentina, Austria, Belgium, Brazil, Canada, Chile, Denmark, France, Germany, Italy, Mexico, Norway, Peru, Russian Federation, South Africa, Sweden
Contacts
Public ContactGonzalo Ernesto Castro
ASTRAZENECA PERU S.A.
Outcome results
None listed