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
NCT ID: NCT01043601
Last Updated: 2014-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
PHASE2
INTERVENTIONAL
2010-07-31
2011-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
PT005 MDI Dose Ranging Versus Foradil Aerolizer Study
NCT01349868
Study to Evaluate the Safety and Efficacy of Inhaled PT005 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT00880490
Study to Evaluate the Efficacy, Safety and Pharmacokinetics of PT001, PT003, and PT005 Following Chronic Dosing (7 Days) in Patients With Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)
NCT01085045
A Study Characterizing Pharmacodynamic Profiles in Subjects With Chronic Obstructive Pulmonary Disease
NCT01113593
Comparison of Aclidinium Bromide and Formoterol Fumarate in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
NCT00706914
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Inhaled PT005 7.2 µg
Inhaled PT005
inhaled, twice daily for 1 week duration
Inhaled PT005 9.6 µg
Inhaled PT005
inhaled, twice daily for 1 week duration
Inhaled Placebo
Inhaled Placebo
inhaled, twice daily for 1 week duration
Formoterol Fumarate 12 µg (Foradil Aerolizer)
Formoterol Fumarate 12 µg (Foradil Aerolizer)
inhaled, twice daily for 1 week duration
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Inhaled PT005
inhaled, twice daily for 1 week duration
Inhaled Placebo
inhaled, twice daily for 1 week duration
Formoterol Fumarate 12 µg (Foradil Aerolizer)
inhaled, twice daily for 1 week duration
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
40 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Pearl Therapeutics, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Pearl Therapeutics, Inc.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Charles Fogarty, MD
Role: PRINCIPAL_INVESTIGATOR
Spartanburg Medical Research
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Spartanburg Medical Research
Spartanburg, South Carolina, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PT0051002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.