Clareo Health | Efficacy and Safety of Two Doses of Formoterol Fumarate MDI (PT005) in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD), Compared to Foradil® Aerolizer® as an Active Control
Efficacy and Safety of Two Doses of Formoterol Fumarate MDI (PT005) in Patients With Stable Chronic Obstructive Pulmonary Disease (COPD), Compared to Foradil® Aerolizer® as an Active Control
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Pearl Therapeutics, Inc.
Age
40–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Signed written informed consent
40 - 80 years of age
Fluency in written and spoken English
Females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods
Current/former smokers with at least a 10 pack-year history of cigarette smoking
A measured post- bronchodilator FEV1/FVC ratio of \< or = 0.70
A measured post- bronchodilator FEV1 \> or = 750ml or 30% predicted and \< or = 80% of predicted normal values
Competent at using the inhalation device
You may not be if
Women who are pregnant or lactating
Primary diagnosis of asthma
Alpha-1 antitrypsin deficiency as the cause of COPD
Active pulmonary diseases
Prior lung volume reduction surgery
Abnormal chest X-ray (or CT scan) not due to the presence of COPD
Hospitalized due to poorly controlled COPD within 12 weeks of Screening
Poorly controlled COPD, defined as the occurrence of acute worsening of COPD requiring corticosteroids or antibiotics or acute worsening of COPD requiring treatment prescribed by a physician within 6 weeks of screening or between screening and visit 2
Lower respiratory tract infection requiring antibiotics within 6 weeks of screening
Clinically significant medical conditions that preclude participation in the study (e.g. clinically significant abnormal ECG or uncontrolled hypertension)
Positive Hepatitis B surface antigen or Hepatitis C antibody
Cancer that has not been in complete remission for at least 5 years
History of hypersensitivity to any beta2-agonists or any study drug component
History of severe milk protein allergy
Known or suspected history of alcohol or drug abuse
Medically unable to withhold short acting bronchodilators for 8-hours
Use of prohibited medications prior to screening and during the study as specified in the protocol
Receiving long-term-oxygen or nocturnal oxygen therapy for \>12 hours a day
Participation in acute phase of pulmonary rehabilitation within 4 weeks of screening or will enter acute phase of pulmonary rehabilitation program during study
Unable to comply with study procedures
Prior participation in a Pearl PT005 study
Requires use of a spacer due to poor hand-to-breath coordination
