COPD
Conditions
Brief summary
The purpose of this study is to evaluate the safety and efficacy of inhaled formoterol fumarate (7.2 and 9.6 µg ex-actuator) compared to placebo and Foradil Aerolizer in patients with moderate to very severe chronic obstructive pulmonary disease (COPD).
Interventions
DRUGInhaled PT005
inhaled, twice daily for 1 week duration
DRUGInhaled Placebo
inhaled, twice daily for 1 week duration
DRUGFormoterol Fumarate 12 µg (Foradil Aerolizer)
inhaled, twice daily for 1 week duration
Sponsors
Pearl Therapeutics, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * 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 Key
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in forced expiratory volume in one second (FEV1) area under the curve from 0 to 12 hours [AUC(0-12)] from test day baseline across the two doses of inhaled PT005 compared with placebo. | Day 7 |
Secondary
| Measure | Time frame |
|---|---|
| Lung Function Measures on Day 7 as measured by spirometry. | Day 7 |
| Safety measures including electrocardiograms (ECGs), vital signs, physical exam, clinical laboratory testing, and adverse events of special interest | Day 7 |
Countries
United States
Outcome results
None listed