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

• Status: Withdrawn
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pearl Therapeutics, Inc.
• Treatments: Formoterol Fumarate

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