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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-salbutamol FEV1/FVC ratio of \< or = 0.70
A measured post-salbutamol FEV1 \> or = 40 and \< or = 80% of predicted normal values
Demonstrated reversibility to a short acting beta agonist by either \>12% and \>150 ml improvement in baseline FEV1, 30 minutes following administration of 4 puffs of salbutamol MDI or an absolute improvement of \>200 ml in baseline FEV1, 30 minutes following administration of 4 puffs of salbutamol MDI.
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 24 weeks of Screening
Poorly controlled COPD in prior 6-weeks, defined as the occurrence of acute worsening of COPD requiring corticosteroids or antibiotics or acute worsening of COPD requiring treatment prescribed by a physician
Clinically significant medical conditions
Lower respiratory tract infection requiring antibiotics in past 6 weeks
Clinically significant abnormal ECG
Clinically significant 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 the medications below in specified time interval prior to Screening: 12-weeks: depot corticosteroids, intra-articular corticosteroids; 4 weeks: ICS \>1000 μg/day of fluticasone propionate or equivalent, non-potassium sparing diuretics, P-glycoprotein inhibitors, CYP3A4 inhibitors; 1 week: tiotropium; 48 hours: oral beta agonists, long acting beta agonists, theophylline, zariflukast, montelukast, zileuton; 8 hours: ipratropium or ipratropium/salbutamol combination product, inhaled short acting beta agonists, xanthine containing foods
Use of the following medications is prohibited: tricyclic antidepressants, monoamine oxidase (MAO) inhibitors, beta-adrenergic antagonists, anticonvulsants (barbiturates,hydantoins, and carbamazepine and phenothiazines
Receiving long-term-oxygen or nocturnal oxygen therapy for \>12 hours a day
Diagnosis of sleep apnea that is uncontrolled
Participation in acute phase of pulmonary rehabilitation in prior 4 weeks or will enter acute phase of pulmonary rehabilitation program during study
Unable to comply with study procedures
Affiliated with Investigator site
Questionable validity of consent
A positive drug of abuse test at Screening lives prior to Screening, whichever is longer
Clareo Health | Study to Evaluate the Safety and Efficacy of Inhaled PT005 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
