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.
COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2011-05-31
2011-07-31
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.
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
NCT01043601
Study to Evaluate the Safety and Efficacy of Inhaled PT005 in Patients With Chronic Obstructive Pulmonary Disease (COPD)
NCT00880490
PT003 MDI Cardiovascular Safety Study
NCT01349803
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
PT003 MDI Dose Confirmation Study
NCT01349816
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
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PT005 MDI (Dose 1)
PT005 MDI (Dose 1)
PT005 MDI
PT005 MDI taken as two inhalations
PT005 MDI (Dose 2)
PT005 MDI (Dose 2)
PT005 MDI
PT005 MDI taken as two inhalations
PT005 MDI (Dose 3)
PT005 MDI (Dose 3)
PT005 MDI
PT005 MDI taken as two inhalations
Placebo MDI
Placebo MDI
Placebo MDI
Matching placebo to PT005 MDI taken as two inhalations
Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
Formoterol fumarate inhalation powder 12 μg
Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
Taken as 1 capsule. Each capsule contains 12 μg corresponding to 10 µg formoterol fumarate dihydrate delivered from the mouthpiece
Formoterol Fumarate 24 μg (Foradil® Aerolizer®)
Formoterol fumarate inhalation powder 24 μg
Formoterol Fumarate 24 μg (Foradil® Aerolizer®)
Taken as 2 capsules. Each capsule contains 12 μg corresponding to 10 µg formoterol fumarate dihydrate delivered from the mouthpiece
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PT005 MDI
PT005 MDI taken as two inhalations
Formoterol Fumarate 12 μg (Foradil® Aerolizer®)
Taken as 1 capsule. Each capsule contains 12 μg corresponding to 10 µg formoterol fumarate dihydrate delivered from the mouthpiece
Formoterol Fumarate 24 μg (Foradil® Aerolizer®)
Taken as 2 capsules. Each capsule contains 12 μg corresponding to 10 µg formoterol fumarate dihydrate delivered from the mouthpiece
Placebo MDI
Matching placebo to PT005 MDI taken as two inhalations
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
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
* Clinical history of COPD with airflow limitation that is not fully reversible
* 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
* Able to change COPD treatment as required by protocol
* Demonstratead reversibility to short acting beta agonist (Ventolin HFA) (\> 12% and \>150 mL improvement in baseline FEV1 approximately 30 minutes following administration of 4 puffs of Ventolin HFA or \> 200 mL improvement in baseline FEV1 30 minutes following administration of 2 puffs of Ventolin HFA)
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 3 months of Screening
* Clinically significant medical conditions that preclude participation in the study (e.g. clinically significant abnormal ECG, uncontrolled hypertension, glaucoma, symptomatic prostatic hypertrophy)
* Cancer that has not been in complete remission for at least 5 years
* Treatment with investigational study drug or participation in another clinical trial or study within the last 30 days or 5 half lives
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.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Pearl Investigative Site
Clearwater, Florida, United States
Pearl Investigative Site
Tampa, Florida, United States
Pearl Investigative Site
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.
PT005003
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.