Pulmonary Disease, Chronic ObstructivePhase 2NCT00219622
A Phase 2 Study of the Safety and Efficacy of a Tofimilast in Adult Patients With Chronic Obstructive Pulmonary Disease
A Phase 2 study testing tofimilast in people with Pulmonary Disease, Chronic Obstructive, run by Pfizer at 40 sites in 6 countries.
Trial summary
This an initial proof of concept, phase to study to assess the safety and efficacy of tofimilast for the chronic maintenance treatment of adults with Chronic Obstructive Pulmonary Disease Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- tofimilast
- How many people
- 300 participants
- Where
- 40 sitesin 6 countries
- Study dates
- May 2004to Jul 2005
- Phase
- Phase 2
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate-severe COPD (GOLD 2003 definition)
- Smoking history of at least 10 pack-years
Who cannot join
- Any significant co-morbid disease, particularly cardiovascular
- Use of any maintenance therapy except short acting bronchodilators
Trial locations and contacts
40 sites in 6 countries.
40 sites in 6 countries
United States23 sites
Pfizer Investigational Site
Bellingham, Washington, 98226
Pfizer Investigational Site
Buffalo, New York, 14215-1199
Pfizer Investigational Site
Charlotte, North Carolina, 28207
Pfizer Investigational Site
Cincinnati, Ohio, 45241
Pfizer Investigational Site
Clearwater, Florida, 33756
Pfizer Investigational Site
Clearwater, Florida, 33765
Pfizer Investigational Site
Dallas, Texas, 75231
Pfizer Investigational Site
Edina, Minnesota, 55438
Pfizer Investigational Site
Iowa City, Iowa, 52240
Pfizer Investigational Site
Lake Oswego, Oregon, 97035
Pfizer Investigational Site
Lincoln, Rhode Island, 02865
Pfizer Investigational Site
Madisonville, Kentucky, 42431
Pfizer Investigational Site
Minneapolis, Minnesota, 55407
Pfizer Investigational Site
Normal, Illinois, 61761
Pfizer Investigational Site
Phoenix, Arizona, 85006
Pfizer Investigational Site
Renton, Washington, 98055
Pfizer Investigational Site
Riverdale, Georgia, 30296
Pfizer Investigational Site
Riverside, California, 92506
Pfizer Investigational Site
Spartanburg, South Carolina, 29303
Pfizer Investigational Site
Spartanburg, South Carolina, 29307
Pfizer Investigational Site
Stockbridge, Georgia, 30281
Pfizer Investigational Site
Tukwila, Washington, 98188
Pfizer Investigational Site
Wheaton, Maryland, 20902
Argentina6 sites
Pfizer Investigational Site
Buenos Aires, 1426
Pfizer Investigational Site
Buenos Aires, C1425BEA
Pfizer Investigational Site
Buenos Aires, C1425DQU
Pfizer Investigational Site
La Plata, Buenos Aires, C1904AGP
Pfizer Investigational Site
Rosario, Santa Fe Province, 2000
Pfizer Investigational Site
Vicente López, Buenos Aires, 1602
Chile4 sites
Pfizer Investigational Site
Providencia, Santiago Metropolitan
Pfizer Investigational Site
Recoleta, Santiago Metropolitan
Pfizer Investigational Site
Santiago
Pfizer Investigational Site
ValparaÃ-so
Brazil3 sites
Pfizer Investigational Site
Curitiba, Paraná, 80060-900
Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, 90035-002
Pfizer Investigational Site
Porto Alegre, Rio Grande do Sul, 90610-000
Mexico3 sites
Pfizer Investigational Site
México, D.f., 14080
Pfizer Investigational Site
Monterrey, Nuevo León
Pfizer Investigational Site
Monterrey, Nuevo León, 64460
Costa Rica1 site
Pfizer Investigational Site
San José, Provincia de San José
About this study
Official title: Phase 2, Randomized, Double-Blind, Placebo-Controlled, Six Week Study Of The Efficacy And Safety Of Tofimilast Dry Powder For Inhalation In Adults Diagnosed With Chronic Obstructive Pulmonary Disease
This an initial proof of concept, phase to study to assess the safety and efficacy of tofimilast for the chronic maintenance treatment of adults with Chronic Obstructive Pulmonary Disease
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- tofimilast
- 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.
tofimilastDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in FEV1 compared to placebo
Secondary outcomes (1)
Change from baseline in other lung function parameters, dyspnea, quality of life compared to placebo
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startMay 2004
- Primary completionJul 2005
- Study completionJul 2005
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 PfizerThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 300 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00219622
- Sponsor's protocol ID
- A2641022
- Status last verified
- Nov 2012
- First submitted
- 11 Sep 2005
- Last updated
- 7 Nov 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2, Randomized, Double-Blind, Placebo-Controlled, Six Week Study Of The Efficacy And Safety Of Tofimilast Dry Powder For Inhalation In Adults Diagnosed With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT00219622
- Acronym / sponsor ID
- A2641022
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- May 2004
- Primary completion
- Jul 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 22 Sep 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 an initial proof of concept, phase to study to assess the safety and efficacy of tofimilast for the chronic maintenance treatment of adults with Chronic Obstructive Pulmonary Disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Moderate-severe COPD (GOLD 2003 definition)
- Smoking history of at least 10 pack-years
Key exclusion criteria (2 listed)
- Any significant co-morbid disease, particularly cardiovascular
- Use of any maintenance therapy except short acting bronchodilators
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 |
|---|---|---|
| tofimilast | Drug | – |
Primary outcome
Change from baseline in FEV1 compared to placebo
1 secondary outcome
Change from baseline in other lung function parameters, dyspnea, quality of life compared to placebo
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 7 Nov 2012.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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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.
Pfizer CT.gov Call Center study director
Pfizer
40 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing tofimilast in people with Pulmonary Disease, Chronic Obstructive, run by Pfizer at 40 sites in 6 countries.
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 2 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 7 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in United States, Argentina, Chile, Brazil, Mexico and 1 more country. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change from baseline in FEV1 compared to placebo. 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 7 Nov 2012.