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
Phase 2
Withdrawn
- Conditions
- COPD
- Interventions
- Registration Number
- NCT01043601
- Lead Sponsor
- Pearl Therapeutics, Inc.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Inhaled PT005 9.6 µg Inhaled PT005 - Inhaled Placebo Inhaled Placebo - Inhaled PT005 7.2 µg Inhaled PT005 - Formoterol Fumarate 12 µg (Foradil Aerolizer) Formoterol Fumarate 12 µg (Foradil Aerolizer) -
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Spartanburg Medical Research
🇺🇸Spartanburg, South Carolina, United States