Pulmonary Disease, Chronic Obstructive Clinical Trial
— A7881013Official title:
A Phase 2b, Parallel Group, Placebo And Active Comparator Controlled Study To Investigate The Safety, Toleration And Efficacy Of 6-Week Once Daily Administration Of Inhaled PF-00610355 Dry Powder In Patients With Moderate Chronic Obstructive Pulmonary Disease.
| NCT number | NCT00808288 |
| Other study ID # | A7881013 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 2 |
| First received | |
| Last updated | |
| Start date | March 2010 |
| Est. completion date | December 2010 |
| Verified date | February 2019 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
To assess the effects and safety of PF-00610355 on patients with chronic obstructive lung disease (COPD)
| Status | Completed |
| Enrollment | 405 |
| Est. completion date | December 2010 |
| Est. primary completion date | December 2010 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 40 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Post-bronchodilator FEV1/FVC ratio <0.7 and a post-bronchodilator FEV1 of 50-80%. - Diagnosis of moderate COPD for a minimum of 6 months. - Stable disease for at least 1 month prior to screening Exclusion Criteria: - More than 2 exacerbations of COPD requiring treatment with oral steroids in the preceding year or hospitalisation for the treatment of COPD within 3 months of screening or more than twice during the preceding year. - History of a lower respiratory tract infection or significant disease instability during the month preceding screening or during the time between screening and randomisation. |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Pfizer Investigational Site | Buenos Aires | |
| Argentina | Pfizer Investigational Site | Buenos Aires | |
| Argentina | Pfizer Investigational Site | Rosario | Santa Fe |
| Bulgaria | Pfizer Investigational Site | Ruse | |
| Bulgaria | Pfizer Investigational Site | Sofia | |
| Bulgaria | Pfizer Investigational Site | Sofia | |
| Bulgaria | Pfizer Investigational Site | Stara Zagora | |
| Bulgaria | Pfizer Investigational Site | Troyan | |
| Croatia | Pfizer Investigational Site | Zagreb | |
| Czechia | Pfizer Investigational Site | Kutna Hora | |
| Czechia | Pfizer Investigational Site | Liberec | |
| Czechia | Pfizer Investigational Site | Praha 5 | |
| Czechia | Pfizer Investigational Site | Tabor | |
| Germany | Pfizer Investigational Site | Berlin | |
| Germany | Pfizer Investigational Site | Berlin | |
| Germany | Pfizer Investigational Site | Frankfurt | |
| Germany | Pfizer Investigational Site | Hamburg | |
| Germany | Pfizer Investigational Site | Kassel | |
| Germany | Pfizer Investigational Site | Luebeck | |
| Germany | Pfizer Investigational Site | Schwerin | |
| Germany | Pfizer Investigational Site | Wiesbaden | |
| Hungary | Pfizer Investigational Site | Budapest | |
| Hungary | Pfizer Investigational Site | Debrecen | |
| Hungary | Pfizer Investigational Site | Szeged | |
| Hungary | Pfizer Investigational Site | Szombathely | |
| Hungary | Pfizer Investigational Site | Torokbalint | |
| Poland | Pfizer Investigational Site | Lodz | |
| Poland | Pfizer Investigational Site | Sopot | |
| Poland | Pfizer Investigational Site | Warszawa | |
| Poland | Pfizer Investigational Site | Wejherowo | |
| Slovakia | Pfizer Investigational Site | Bojnice | |
| Slovakia | Pfizer Investigational Site | Bratislava | |
| Slovakia | Pfizer Investigational Site | Liptovsky Hradok | |
| Slovakia | Pfizer Investigational Site | Nove Zamky | |
| Slovakia | Pfizer Investigational Site | Poprad | |
| Slovakia | Pfizer Investigational Site | Spisska Nova Ves | |
| South Africa | Pfizer Investigational Site | Bellville | Cape Town |
| South Africa | Pfizer Investigational Site | Bloemfontein | Free State |
| South Africa | Pfizer Investigational Site | Bloemfontein | |
| South Africa | Pfizer Investigational Site | Gatesville, Cape Town | |
| South Africa | Pfizer Investigational Site | Tygerberg | Cape Town |
| Spain | Pfizer Investigational Site | Pozuelo de Alarcon | Madrid |
| Spain | Pfizer Investigational Site | Salt | Girona |
| Turkey | Pfizer Investigational Site | Istanbul | |
| Turkey | Pfizer Investigational Site | Izmir | |
| United States | Pfizer Investigational Site | Austell | Georgia |
| United States | Pfizer Investigational Site | Charleston | South Carolina |
| United States | Pfizer Investigational Site | Charleston | South Carolina |
| United States | Pfizer Investigational Site | Charlotte | North Carolina |
| United States | Pfizer Investigational Site | Cincinnati | Ohio |
| United States | Pfizer Investigational Site | Cincinnati | Ohio |
| United States | Pfizer Investigational Site | Cincinnati | Ohio |
| United States | Pfizer Investigational Site | Cincinnati | Ohio |
| United States | Pfizer Investigational Site | Columbia | South Carolina |
| United States | Pfizer Investigational Site | Daytona Beach | Florida |
| United States | Pfizer Investigational Site | Fairhope | Alabama |
| United States | Pfizer Investigational Site | Fridley | Minnesota |
| United States | Pfizer Investigational Site | Houston | Texas |
| United States | Pfizer Investigational Site | Lincoln | Rhode Island |
| United States | Pfizer Investigational Site | Minneapolis | Minnesota |
| United States | Pfizer Investigational Site | Morgantown | West Virginia |
| United States | Pfizer Investigational Site | Oklahoma City | Oklahoma |
| United States | Pfizer Investigational Site | Ormond Beach | Florida |
| United States | Pfizer Investigational Site | Overland Park | Kansas |
| United States | Pfizer Investigational Site | Overland Park | Kansas |
| United States | Pfizer Investigational Site | Pawtucket | Rhode Island |
| United States | Pfizer Investigational Site | Rochester | New York |
| United States | Pfizer Investigational Site | Rochester | Minnesota |
| United States | Pfizer Investigational Site | Saint Louis | Missouri |
| United States | Pfizer Investigational Site | San Antonio | Texas |
| United States | Pfizer Investigational Site | San Diego | California |
| United States | Pfizer Investigational Site | Spring Valley | California |
| United States | Pfizer Investigational Site | Tampa | Florida |
| United States | Pfizer Investigational Site | Trinity | Florida |
| United States | Pfizer Investigational Site | Wheat Ridge | Colorado |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States, Argentina, Bulgaria, Croatia, Czechia, Germany, Hungary, Poland, Slovakia, South Africa, Spain, Turkey,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change from baseline in trough FEV1 | 6 week | ||
| Secondary | Maximal and mean changes from baseline in heart rate, QTc and plasma potassium | each visit | ||
| Secondary | Change from baseline in peak FEV1 | 0-6 hours /6 weeks | ||
| Secondary | Change from baseline in trough and peak FEV6, FVC and IC | 6 weeks | ||
| Secondary | Change from baseline in trough FEV1, FEV6, forced vital capacity (FVC) and inspiratory capacity (IC) | 2 and 4 weeks | ||
| Secondary | Change from baseline in Respiratory Questionnaire Self-Administered Standardised (CRQ-SAS) | 2,4,6 weeks | ||
| Secondary | Change from baseline of COPD symptoms and rescue bronchodilator use (per daily diary). | weekly |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05043428 -
The Roles of Peers and Functional Tasks in Enhancing Exercise Training for Adults With COPD
|
N/A | |
| Completed |
NCT00528996 -
An Efficacy and Safety Study to Compare Three Doses of BEA 2180 BR to Tiotropium and Placebo in the Respimat Inhaler.
|
Phase 2 | |
| Completed |
NCT03740373 -
A Study to Assess the Pulmonary Distribution of Budesonide, Glycopyrronium and Formoterol Fumarate
|
Phase 1 | |
| Completed |
NCT05402020 -
Effectiveness of Tiotropium + Olodaterol Versus Inhaled Corticosteroids (ICS) + Long-acting β2-agonists (LABA) Among COPD Patients in Taiwan
|
||
| Completed |
NCT05393245 -
Safety of Tiotropium + Olodaterol in Chronic Obstructive Pulmonary Disease (COPD) Patients in Taiwan: a Non-interventional Study Based on the Taiwan National Health Insurance (NHI) Data
|
||
| Completed |
NCT04011735 -
Re-usable Respimat® Soft MistTM Inhaler Study
|
||
| Enrolling by invitation |
NCT03075709 -
The Development, Implementation and Evaluation of Clinical Pathways for Chronic Obstructive Pulmonary Disease (COPD) in Saskatchewan
|
||
| Completed |
NCT03764163 -
Image and Model Based Analysis of Lung Disease
|
Early Phase 1 | |
| Completed |
NCT00515268 -
Endotoxin Challenge Study For Healthy Men and Women
|
Phase 1 | |
| Completed |
NCT04085302 -
TARA Working Prototype Engagement Evaluation: Feasibility Study
|
N/A | |
| Completed |
NCT03691324 -
Training of Inhalation Technique in Hospitalized Chronic Obstructive Pulmonary Disease (COPD) Patients - a Pilot Study
|
N/A | |
| Completed |
NCT02236611 -
A 12-week Study to Evaluate the Efficacy and Safety of Umeclidinium 62.5 Microgram (mcg) Compared With Glycopyrronium 44 mcg in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 4 | |
| Completed |
NCT00153075 -
Flow Rate Effect Respimat Inhaler Versus a Metered Dose Inhaler Using Berodual in Patients With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 4 | |
| Completed |
NCT01017952 -
A Study to Evaluate Annual Rate of Exacerbations and Safety of 3 Dosage Strengths of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 3 | |
| Completed |
NCT01009463 -
A Study to Evaluate the Efficacy and Safety of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 3 | |
| Completed |
NCT04882124 -
Study of Effect of CSJ117 on Symptoms, Pharmacodynamics and Safety in Patients With COPD
|
Phase 2 | |
| Completed |
NCT02853123 -
Effect of Tiotropium + Olodaterol on Breathlessness in COPD Patients
|
Phase 4 | |
| Completed |
NCT02619357 -
Method Validation Study to Explore the Sensitivity of SenseWear Armband Gecko for Measuring Physical Activity in Subjects With Chronic Obstructive Pulmonary Disease (COPD) & Asthma
|
Phase 1 | |
| Recruiting |
NCT05858463 -
High Intensity Interval Training and Muscle Adaptations During PR
|
N/A | |
| Not yet recruiting |
NCT05032898 -
Acute Exacerbation of Chronic Obstructive Pulmonary Disease Inpatient Registry Study Stage II
|