Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
A Randomized, Double-blind, Parallel Group, 14-day, Multi-Center Study to Evaluate the Safety of PT003, PT005, PT001 and Foradil® Aerolizer® (12 µg, Open Label) as Evaluated by Holter Monitoring, in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Verified date | May 2013 |
Source | Pearl Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
This study is primarily a safety study. The primary and secondary endpoints are based on 24-hour Holter monitor assessments obtained on Day 14 relative to baseline.
Status | Completed |
Enrollment | 237 |
Est. completion date | November 2011 |
Est. primary completion date | November 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 80 Years |
Eligibility |
Key Inclusion Criteria: - Signed written informed consent - 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 - Acceptable baseline (Visit 2) Holter monitor recording 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 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 - Clinically significant abnormal findings during the baseline Holter recording - Patients with a pacemaker or ICD/CRT/CRT_D devices Other inclusion/exclusion criteria as defined by the protocol |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Pearl Investigative Site | Caboolture | Queensland |
Australia | Pearl Investigative Site | Dawpark | South Australia |
Australia | Pearl Investigative Site | Glebe | New South Wales |
Australia | Pearl Investigative Site | Heidelberg | Victoria |
Australia | Pearl Investigative Site | Nedlands | Western Australia |
Australia | Pearl Investigative Site | Toorak Gardens | South Australia |
New Zealand | Pearl Investigative Site | Caversham | Dunedin |
New Zealand | Pearl Investigative Site | Newtown | Wellington |
New Zealand | Pearl Investigative Site | Private Bag | Hamilton |
New Zealand | Pearl Investigative Site | Tauranga | North Island |
United States | Pearl Investigative Site | Fullerton | California |
United States | Pearl Investigative Site | Glendale | Arizona |
United States | Pearl Investigative Site | Lafayette | Louisiana |
United States | Pearl Investigative Site | Livonia | Michigan |
United States | Pearl Investigative Site | Los Angeles | California |
United States | Pearl Investigative Site | Medford | Oregon |
United States | Pearl Investigative Site | North Dartmouth | Massachusetts |
United States | Pearl Investigative Site | Pensacola | Florida |
United States | Pearl Investigative Site | San Antonio | Texas |
United States | Pearl Investigative Site | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
Pearl Therapeutics, Inc. |
United States, Australia, New Zealand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Mean Heart Rate Average Over 24 Hours Post-dose | The primary safety objective of this study is to compare the change in mean heart rate averaged over 24 hours post-dose, following twice daily dosing over 14 days with PT003 MDI, PT005 MDI, PT001 MDI or Foradil Aerolizer compared to baseline in patients with moderate to severe chronic obstructive pulmonary disease (COPD). | 14 days | Yes |
Secondary | Characterization of additional cardiovascular safety parameters | The secondary objective of the study is to further characterize additional cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation). | 24 hours | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05102305 -
A Multi-center,Prospective, OS to Evaluate the Effectiveness of 'NAC' Nebulizer Therapy in COPD (NEWEST)
|
||
Completed |
NCT01867762 -
An Effectiveness and Safety Study of Inhaled JNJ 49095397 (RV568) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
|
Phase 2 | |
Recruiting |
NCT05562037 -
Stepped Care vs Center-based Cardiopulmonary Rehabilitation for Older Frail Adults Living in Rural MA
|
N/A | |
Terminated |
NCT04921332 -
Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD
|
N/A | |
Completed |
NCT03089515 -
Small Airway Chronic Obstructive Disease Syndrome Following Exposure to WTC Dust
|
N/A | |
Completed |
NCT02787863 -
Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology
|
Phase 4 | |
Recruiting |
NCT05552833 -
Pulmonary Adaptive Responses to HIIT in COPD
|
N/A | |
Recruiting |
NCT05835492 -
A Pragmatic Real-world Multicentre Observational Research Study to Explore the Clinical and Health Economic Impact of myCOPD
|
||
Recruiting |
NCT05631132 -
May Noninvasive Mechanical Ventilation (NIV) and/or Continuous Positive Airway Pressure (CPAP) Increase the Bronchoalveolar Lavage (BAL) Salvage in Patients With Pulmonary Diseases?
|
N/A | |
Completed |
NCT03244137 -
Effects of Pulmonary Rehabilitation on Cognitive Function in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease
|
||
Not yet recruiting |
NCT03282526 -
Volume Parameters vs Flow Parameters in Assessment of Reversibility in Chronic Obstructive Pulmonary Disease
|
N/A | |
Completed |
NCT02546700 -
A Study to Evaluate Safety and Efficacy of Lebrikizumab in Participants With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 2 | |
Withdrawn |
NCT04446637 -
Acute Bronchodilator Effects of Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination vs Salbutamol 100 mcg Inhaler Plus Ipratropium 20 mcg Inhalation Aerosol Free Combination in Patients With Stable COPD
|
Phase 3 | |
Completed |
NCT04535986 -
A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD
|
Phase 3 | |
Recruiting |
NCT05865184 -
Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
|
||
Completed |
NCT03256695 -
Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Participants With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 3 | |
Completed |
NCT03295474 -
Telemonitoring in Pulmonary Rehabilitation: Feasibility and Acceptability of a Remote Pulse Oxymetry System.
|
||
Withdrawn |
NCT04042168 -
Implications of Appropriate Use of Inhalers in Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 4 | |
Completed |
NCT03414541 -
Safety And Efficacy Study Of Orally Administered DS102 In Patients With Chronic Obstructive Pulmonary Disease
|
Phase 2 | |
Completed |
NCT02552160 -
DETECT-Register DocumEnTation and Evaluation of a COPD Combination Therapy
|