Pulmonary Disease, Chronic ObstructivePhase 3NCT00103922
Study In Subjects With COPD (Chronic Obstructive Pulmonary Disease)
A Phase 3 study testing cilomilast in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 115 sites in United States.
Trial summary
This study was designed to determine if the investigational drug is effective and safe in individuals with COPD (chronic pulmonary disease) Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- cilomilast
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 115 sitesUnited States
- Study dates
- Nov 2004to Jan 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of COPD and a history of cigarette smoking.
Who cannot join
- Significant heart or lung disease not associated with COPD.
- Significant stomach or intestinal disease.
Trial locations and contacts
115 sites in 1 country.
115 sites in 1 country
United States115 sites
GSK Investigational Site
Allentown, Pennsylvania, 18103
GSK Investigational Site
Atlanta, Georgia, 30342
GSK Investigational Site
Aventura, Florida, 33180
GSK Investigational Site
Bellingham, Washington, 98225
GSK Investigational Site
Berkeley, California, 94705
GSK Investigational Site
Billings, Montana, 59102
GSK Investigational Site
Birmingham, Alabama, 35209
GSK Investigational Site
Boston, Massachusetts, 02135
GSK Investigational Site
Boulder, Colorado, 80304
GSK Investigational Site
Brandon, Florida, 33511
GSK Investigational Site
Bristol, Tennessee, 37620
GSK Investigational Site
Bronxville, New York, 10708
GSK Investigational Site
Cadillac, Michigan, 49601
GSK Investigational Site
Carmichael, California, 95608
GSK Investigational Site
Chapel Hill, North Carolina, 27599
GSK Investigational Site
Chardon, Ohio, 44024
GSK Investigational Site
Charleston, South Carolina, 29406-7108
GSK Investigational Site
Charlotte, North Carolina, 28207
GSK Investigational Site
Chattanooga, Tennessee, 37403
GSK Investigational Site
Cherry Hill, New Jersey, 08003
GSK Investigational Site
Coeur d'Alene, Idaho, 83814
GSK Investigational Site
Colorado Springs, Colorado, 80907
GSK Investigational Site
Columbus, Ohio, 43215
GSK Investigational Site
Corsicana, Texas, 75110
GSK Investigational Site
Cortland, New York, 14850
GSK Investigational Site
Dallas, Texas, 75246
GSK Investigational Site
Dayton, Ohio, 45406
GSK Investigational Site
Decatur, Georgia, 30033
GSK Investigational Site
DeLand, Florida, 32720
GSK Investigational Site
Denver, Colorado, 80230
GSK Investigational Site
Downington, Pennsylvania, 19335
GSK Investigational Site
East Providence, Rhode Island, 02914
GSK Investigational Site
Elizabeth City, North Carolina, 27909
GSK Investigational Site
Elverson, Pennsylvania, 19520
GSK Investigational Site
Englewood, Colorado, 80112
GSK Investigational Site
Erie, Pennsylvania, 16508
GSK Investigational Site
Evansville, Indiana, 47710
GSK Investigational Site
Fort Collins, Colorado, 80528
GSK Investigational Site
Fort Lauderdale, Florida, 33316
GSK Investigational Site
Fort Worth, Texas, 76104
GSK Investigational Site
Fullerton, California, 92835
GSK Investigational Site
Gaffney, South Carolina, 29340
GSK Investigational Site
Greer, South Carolina, 29651
GSK Investigational Site
Hartford, Connecticut, 06105
GSK Investigational Site
High Point, North Carolina, 27262
GSK Investigational Site
Jasper, Alabama, 35501
GSK Investigational Site
Jefferson City, Missouri, 65109
GSK Investigational Site
Johnson City, Tennessee, 37601
GSK Investigational Site
Knoxville, Tennessee, 37920
GSK Investigational Site
Lafayette, Louisiana, 70503
GSK Investigational Site
Lake Oswego, Oregon, 97035
GSK Investigational Site
Larchmont, New York, 10538
GSK Investigational Site
Largo, Florida, 33770
GSK Investigational Site
Las Vegas, Nevada, 89104
GSK Investigational Site
Long Beach, California, 90806
GSK Investigational Site
Long Beach, California, 90822
GSK Investigational Site
Longwood, Florida, 32779
GSK Investigational Site
Los Angeles, California, 90048
GSK Investigational Site
Madisonville, Kentucky, 42431
GSK Investigational Site
Medford, Oregon, 97504
GSK Investigational Site
Melbourne, Florida, 32935
GSK Investigational Site
Milwaukee, Wisconsin, 53209-0996
GSK Investigational Site
Minneapolis, Minnesota, 55402
GSK Investigational Site
Missoula, Montana, 59808
GSK Investigational Site
Morgantown, West Virginia, 26505
GSK Investigational Site
Murrieta, California, 92562
GSK Investigational Site
New Orleans, Louisiana, 70119
GSK Investigational Site
New York, New York, 10016
GSK Investigational Site
Normal, Illinois, 61761
GSK Investigational Site
Panama City, Florida, 32405
GSK Investigational Site
Pensacola, Florida, 32504
GSK Investigational Site
Phoenix, Arizona, 85006
GSK Investigational Site
Pittsburgh, Pennsylvania, 15213
GSK Investigational Site
Pittsburgh, Pennsylvania, 15218
GSK Investigational Site
Pittsburgh, Pennsylvania, 15243
GSK Investigational Site
Portland, Oregon, 97213
GSK Investigational Site
Rancho Mirage, California, 92270
GSK Investigational Site
Richmond, Virginia, 23225
GSK Investigational Site
Richmond, Virginia, 23229
GSK Investigational Site
Riverside, California, 92805
GSK Investigational Site
Sacramento, California, 95823
GSK Investigational Site
Saint Charles, Missouri, 63301
GSK Investigational Site
Salt Lake City, Utah, 84102
GSK Investigational Site
San Antonio, Texas, 78205
GSK Investigational Site
San Antonio, Texas, 78217
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
San Diego, California, 92103
GSK Investigational Site
San Diego, California, 92120
GSK Investigational Site
San Jose, California, 95117
GSK Investigational Site
Sepulveda, California, 91343
GSK Investigational Site
Simpsonville, South Carolina, 29681
GSK Investigational Site
Slidell, Louisiana, 70461
GSK Investigational Site
South Bend, Indiana, 46617
GSK Investigational Site
Spartanburg, South Carolina, 29303
GSK Investigational Site
Spokane, Washington, 99204
GSK Investigational Site
Spokane, Washington, 99207
GSK Investigational Site
St Louis, Missouri, 63122
GSK Investigational Site
St Louis, Missouri, 63141
GSK Investigational Site
Stamford, Connecticut, 06902
GSK Investigational Site
Statesville, North Carolina, 28625
GSK Investigational Site
Stockton, California, 95207
GSK Investigational Site
Sunset, Louisiana, 70584
GSK Investigational Site
Swarthmore, Pennsylvania, 19081
GSK Investigational Site
Sylvania, Ohio, 43560
GSK Investigational Site
Tacoma, Washington, 98405
GSK Investigational Site
Tamarac, Florida, 33321
GSK Investigational Site
Tampa, Florida, 33613
GSK Investigational Site
Tempe, Arizona, 85282
GSK Investigational Site
Torrance, California, 90509
GSK Investigational Site
Vista, California, 92083
GSK Investigational Site
Walnut Creek, California, 94598
GSK Investigational Site
Waterbury, Connecticut, 06708
GSK Investigational Site
West Palm Beach, Florida, 33409
GSK Investigational Site
Wheat Ridge, Colorado, 80033
GSK Investigational Site
Wichita, Kansas, 67207
About this study
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)
This study was designed to determine if the investigational drug is effective and safe in individuals with COPD (chronic pulmonary disease)
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- cilomilast
- Keywords
- smokers cough
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cilomilastDrug
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: cilomilast |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure of lung function and quality of life in patients with COPD
Secondary outcomes (1)
exacerbations in patients with COPD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2005 (estimated)
- Study startNov 2004
- Primary completionJan 2007
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00103922
- Sponsor's protocol ID
- CIL103657
- Status last verified
- Oct 2016
- First submitted
- 17 Feb 2005
- Last updated
- 28 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00103922
- Acronym / sponsor ID
- CIL103657
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- smokers cough
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 18 Feb 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was designed to determine if the investigational drug is effective and safe in individuals with COPD (chronic pulmonary disease)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: cilomilast |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of COPD and a history of cigarette smoking.
Key exclusion criteria (2 listed)
- Significant heart or lung disease not associated with COPD.
- Significant stomach or intestinal disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cilomilast | Drug | Arm 1 |
Primary outcome
measure of lung function and quality of life in patients with COPD
1 secondary outcome
exacerbations in patients with COPD
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2016.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
115 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cilomilast in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 115 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 115 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measure of lung function and quality of life in patients with COPD. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2016.