Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
A Randomized, 24-week, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety and Tolerability of ARIFLO® (15mg BID) in Patients With Chronic Obstructive Pulmonary Disease (COPD)
| Verified date | October 2016 |
| Source | GlaxoSmithKline |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study was designed to determine if the investigational drug is effective and safe in individuals with COPD (chronic pulmonary disease)
| Status | Completed |
| Enrollment | 600 |
| Est. completion date | January 2007 |
| Est. primary completion date | January 2007 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 40 Years and older |
| Eligibility |
Inclusion criteria: - Diagnosis of COPD and a history of cigarette smoking. Exclusion criteria: - Significant heart or lung disease not associated with COPD. - Significant stomach or intestinal disease. |
| Country | Name | City | State |
|---|---|---|---|
| United States | GSK Investigational Site | Allentown | Pennsylvania |
| United States | GSK Investigational Site | Atlanta | Georgia |
| United States | GSK Investigational Site | Aventura | Florida |
| United States | GSK Investigational Site | Bellingham | Washington |
| United States | GSK Investigational Site | Berkeley | California |
| United States | GSK Investigational Site | Billings | Montana |
| United States | GSK Investigational Site | Birmingham | Alabama |
| United States | GSK Investigational Site | Boston | Massachusetts |
| United States | GSK Investigational Site | Boulder | Colorado |
| United States | GSK Investigational Site | Brandon | Florida |
| United States | GSK Investigational Site | Bristol | Tennessee |
| United States | GSK Investigational Site | Bronxville | New York |
| United States | GSK Investigational Site | Cadillac | Michigan |
| United States | GSK Investigational Site | Carmichael | California |
| United States | GSK Investigational Site | Chapel Hill | North Carolina |
| United States | GSK Investigational Site | Chardon | Ohio |
| United States | GSK Investigational Site | Charleston | South Carolina |
| United States | GSK Investigational Site | Charlotte | North Carolina |
| United States | GSK Investigational Site | Chattanooga | Tennessee |
| United States | GSK Investigational Site | Cherry Hill | New Jersey |
| United States | GSK Investigational Site | Coeur D'Alene | Idaho |
| United States | GSK Investigational Site | Colorado Springs | Colorado |
| United States | GSK Investigational Site | Columbus | Ohio |
| United States | GSK Investigational Site | Corsicana | Texas |
| United States | GSK Investigational Site | Cortland | New York |
| United States | GSK Investigational Site | Dallas | Texas |
| United States | GSK Investigational Site | Dayton | Ohio |
| United States | GSK Investigational Site | Decatur | Georgia |
| United States | GSK Investigational Site | Deland | Florida |
| United States | GSK Investigational Site | Denver | Colorado |
| United States | GSK Investigational Site | Downington | Pennsylvania |
| United States | GSK Investigational Site | East Providence | Rhode Island |
| United States | GSK Investigational Site | Elizabeth City | North Carolina |
| United States | GSK Investigational Site | Elverson | Pennsylvania |
| United States | GSK Investigational Site | Englewood | Colorado |
| United States | GSK Investigational Site | Erie | Pennsylvania |
| United States | GSK Investigational Site | Evansville | Indiana |
| United States | GSK Investigational Site | Fort Collins | Colorado |
| United States | GSK Investigational Site | Fort Lauderdale | Florida |
| United States | GSK Investigational Site | Fort Worth | Texas |
| United States | GSK Investigational Site | Fullerton | California |
| United States | GSK Investigational Site | Gaffney | South Carolina |
| United States | GSK Investigational Site | Greer | South Carolina |
| United States | GSK Investigational Site | Hartford | Connecticut |
| United States | GSK Investigational Site | High Point | North Carolina |
| United States | GSK Investigational Site | Jasper | Alabama |
| United States | GSK Investigational Site | Jefferson City | Missouri |
| United States | GSK Investigational Site | Johnson City | Tennessee |
| United States | GSK Investigational Site | Knoxville | Tennessee |
| United States | GSK Investigational Site | Lafayette | Louisiana |
| United States | GSK Investigational Site | Lake Oswego | Oregon |
| United States | GSK Investigational Site | Larchmont | New York |
| United States | GSK Investigational Site | Largo | Florida |
| United States | GSK Investigational Site | Las Vegas | Nevada |
| United States | GSK Investigational Site | Long Beach | California |
| United States | GSK Investigational Site | Long Beach | California |
| United States | GSK Investigational Site | Longwood | Florida |
| United States | GSK Investigational Site | Los Angeles | California |
| United States | GSK Investigational Site | Madisonville | Kentucky |
| United States | GSK Investigational Site | Medford | Oregon |
| United States | GSK Investigational Site | Melbourne | Florida |
| United States | GSK Investigational Site | Milwaukee | Wisconsin |
| United States | GSK Investigational Site | Minneapolis | Minnesota |
| United States | GSK Investigational Site | Missoula | Montana |
| United States | GSK Investigational Site | Morgantown | West Virginia |
| United States | GSK Investigational Site | Murrieta | California |
| United States | GSK Investigational Site | New Orleans | Louisiana |
| United States | GSK Investigational Site | New York | New York |
| United States | GSK Investigational Site | Normal | Illinois |
| United States | GSK Investigational Site | Panama City | Florida |
| United States | GSK Investigational Site | Pensacola | Florida |
| United States | GSK Investigational Site | Phoenix | Arizona |
| United States | GSK Investigational Site | Pittsburgh | Pennsylvania |
| United States | GSK Investigational Site | Pittsburgh | Pennsylvania |
| United States | GSK Investigational Site | Pittsburgh | Pennsylvania |
| United States | GSK Investigational Site | Portland | Oregon |
| United States | GSK Investigational Site | Rancho Mirage | California |
| United States | GSK Investigational Site | Richmond | Virginia |
| United States | GSK Investigational Site | Richmond | Virginia |
| United States | GSK Investigational Site | Riverside | California |
| United States | GSK Investigational Site | Sacramento | California |
| United States | GSK Investigational Site | Salt Lake City | Utah |
| United States | GSK Investigational Site | San Antonio | Texas |
| United States | GSK Investigational Site | San Antonio | Texas |
| United States | GSK Investigational Site | San Antonio | Texas |
| United States | GSK Investigational Site | San Diego | California |
| United States | GSK Investigational Site | San Diego | California |
| United States | GSK Investigational Site | San Jose | California |
| United States | GSK Investigational Site | Sepulveda | California |
| United States | GSK Investigational Site | Simpsonville | South Carolina |
| United States | GSK Investigational Site | Slidell | Louisiana |
| United States | GSK Investigational Site | South Bend | Indiana |
| United States | GSK Investigational Site | Spartanburg | South Carolina |
| United States | GSK Investigational Site | Spokane | Washington |
| United States | GSK Investigational Site | Spokane | Washington |
| United States | GSK Investigational Site | St. Charles | Missouri |
| United States | GSK Investigational Site | St. Louis | Missouri |
| United States | GSK Investigational Site | St. Louis | Missouri |
| United States | GSK Investigational Site | Stamford | Connecticut |
| United States | GSK Investigational Site | Statesville | North Carolina |
| United States | GSK Investigational Site | Stockton | California |
| United States | GSK Investigational Site | Sunset | Louisiana |
| United States | GSK Investigational Site | Swarthmore | Pennsylvania |
| United States | GSK Investigational Site | Sylvania | Ohio |
| United States | GSK Investigational Site | Tacoma | Washington |
| United States | GSK Investigational Site | Tamarac | Florida |
| United States | GSK Investigational Site | Tampa | Florida |
| United States | GSK Investigational Site | Tempe | Arizona |
| United States | GSK Investigational Site | Torrance | California |
| United States | GSK Investigational Site | Vista | California |
| United States | GSK Investigational Site | Walnut Creek | California |
| United States | GSK Investigational Site | Waterbury | Connecticut |
| United States | GSK Investigational Site | West Palm Beach | Florida |
| United States | GSK Investigational Site | Wheat Ridge | Colorado |
| United States | GSK Investigational Site | Wichita | Kansas |
| Lead Sponsor | Collaborator |
|---|---|
| GlaxoSmithKline |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | measure of lung function and quality of life in patients with COPD | |||
| Secondary | exacerbations in patients with COPD |
| 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 |
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 |
NCT05402020 -
Effectiveness of Tiotropium + Olodaterol Versus Inhaled Corticosteroids (ICS) + Long-acting β2-agonists (LABA) Among COPD Patients in Taiwan
|
||
| 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
|