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
40–75
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Signed written informed consent
40 - 75 years of age
Females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods
COPD diagnosis
Current/former smokers with at least a 10 pack-year history of cigarette smoking
Patients with established clinical history of COPD and severity defined as a post-ipratropium FEV1/FVC ratio of ≤0.70 and FEV1 ≥50 and ≤85% of predicted normal at Screening
Must demonstrate reversibility to ipratropium demonstrated by a \>200 mL improvement over baseline and/or \>12% and \>150 mL improvement over baseline
Patients willing to stay at study site for at least 24 hours on each test day
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
Unable to perform acceptable spirometry
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
Symptomatic prostatic hypertrophy or bladder neck obstruction
Known narrow-angle glaucoma
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 anticholinergics
History of severe milk protein allergy
Known or suspected history of alcohol or drug abuse
Medically unable to withhold short acting bronchodilators for 6-hours
Use of the medications below in specified time interval prior to Screening: 3 months: depot corticosteroids, intra-articular corticosteroids; 6 weeks: oral corticosteroids, antibiotics administered for a COPD exacerbation; and 1 month: P-glycoprotein inhibitors, CYP450 3A4 inhibitors, ICS \>1000 μg/day of fluticasone propionate or equivalent
The following COPD medications need to be stopped and switched to appropriate replacement therapies: tiotropium, oral beta2 agonists, LABAs, combination corticosteroid/LABAs, theophylline, leukotriene inhibitors,cromoglycate and nedocromil
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
Will enter acute phase of pulmonary rehabilitation program during study
Unable to comply with study procedures
Affiliated with Investigator site
Questionable validity of consent
Use of investigational study drug/participation in clinical study in the last 30 days or 5 half lives prior to Screening, whichever is longer
