Pulmonary Disease, Chronic ObstructivePhase 2NCT00263874
Phase 2 Study of the Safety and Efficacy of UK-500,001 in Adult Patients With COPD
A Phase 2 study testing UK-500,001 in people with Pulmonary Disease, Chronic Obstructive, run by Pfizer at 28 sites in 10 countries.
Trial summary
This initial proof of concept, phase II study aims to assess the safety and efficacy of UK-500,001 for the chronic maintenance treatment of adults with Chronic Obstructive Pulmonary Disease. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- UK-500,001
- How many people
- 324 participants
- Where
- 28 sitesin 10 countries
- Study dates
- Nov 2005to Sep 2006
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Moderate-severe COPD (Global inititiative for chronic Obstructive Lung Disease, GOLD, 2003 definition)
- Smoking history of at least 10 pack-years
Who cannot join
- Any significant co-morbid disease
- Use of any maintenance therapy except short acting bronchodilators
Trial locations and contacts
28 sites in 10 countries.
28 sites in 10 countries
Argentina5 sites
Pfizer Investigational Site
Buenos Aires, 1426
Pfizer Investigational Site
Buenos Aires, C1425DQU
Pfizer Investigational Site
La Plata, Buenos Aires, C1904AGP
Pfizer Investigational Site
Rosario, Santa Fé, 2000
Pfizer Investigational Site
Vicente López, Buenos Aires, 1602
Canada4 sites
Pfizer Investigational Site
Calgary, Alberta, T1Y 6J4
Pfizer Investigational Site
Hamilton, Ontario, L8N 3Z5
Pfizer Investigational Site
Kingston, Ontario, K7L 2V7
Pfizer Investigational Site
Red Deer, Alberta, T4N 6V7
Czechia4 sites
Pfizer Investigational Site
Olomouc, 775 20
Pfizer Investigational Site
Ostrava-Poruba, 708 52
Pfizer Investigational Site
Prague, 150 06
Pfizer Investigational Site
Tábor, 390 03
Australia3 sites
Pfizer Investigational Site
Camperdown, New South Wales, 2050
Pfizer Investigational Site
Clayton, Victoria, 3168a
Pfizer Investigational Site
Nedlands, Western Australia, 6009
Chile3 sites
Pfizer Investigational Site
Providencia, Santiago Metropolitan, 7500691
Pfizer Investigational Site
Santiago, RM, 7500691
Pfizer Investigational Site
ValparaÃ-so, ValparaÃ-so, 2381594
Hungary3 sites
Pfizer Investigational Site
Debrecen, 4004
Pfizer Investigational Site
Törökbálint, 2045
Pfizer Investigational Site
Veszprém, 8200
Singapore2 sites
Pfizer Investigational Site
Singapore, 308433
Pfizer Investigational Site
Singapore, 529889
Spain2 sites
Pfizer Investigational Site
Madrid, Madrid, 28007
Pfizer Investigational Site
Madrid, Madrid, 28046
About this study
Official title: A Phase II Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of UK-500,001 Dry Powder For Inhalation (DPI) In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD).
This initial proof of concept, phase II study aims to assess the safety and efficacy of UK-500,001 for the chronic maintenance treatment of adults with Chronic Obstructive Pulmonary Disease.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- UK-500,001
- 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.
UK-500,001Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in forced expiratory volume in 1 second (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 posted9 Dec 2005 (estimated)
- Study startNov 2005
- Study completionSep 2006
Why it stopped: The decision to terminate was completely related to efficacy and there were no safety concerns.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 324 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00263874
- Sponsor's protocol ID
- A5641009
- Status last verified
- Jul 2007
- First submitted
- 8 Dec 2005
- Last updated
- 23 Jul 2007
- Results posted
- No
Publications
Vestbo J, Tan L, Atkinson G, Ward J; UK-500,001 Global Study Team. A controlled trial of 6-weeks' treatment with a novel inhaled phosphodiesterase type-4 inhibitor in COPD. Eur Respir J. 2009 May;33(5):1039-44. doi: 10.1183/09031936.00068908. Epub 2009 Feb 12.
PubMed 19213793
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of UK-500,001 Dry Powder For Inhalation (DPI) In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD).
- ClinicalTrials.gov ID
- NCT00263874
- Acronym / sponsor ID
- A5641009
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The decision to terminate was completely related to efficacy and there were no safety concerns.
- Enrolment
- 324 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2005
- Study completion
- Sep 2006
- First posted
- 9 Dec 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 initial proof of concept, phase II study aims to assess the safety and efficacy of UK-500,001 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 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Moderate-severe COPD (Global inititiative for chronic Obstructive Lung Disease, GOLD, 2003 definition)
- Smoking history of at least 10 pack-years
Key exclusion criteria (2 listed)
- Any significant co-morbid disease
- 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 |
|---|---|---|
| UK-500,001 | Drug | – |
Primary outcome
Change from baseline in forced expiratory volume in 1 second (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 was stopped early (reason given: The decision to terminate was completely related to efficacy and there were no safety concerns.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2007.
- Derived from this study: PubMed 19213793Vestbo J, Tan L, Atkinson G, Ward J; UK-500,001 Global Study Team. A controlled trial of 6-weeks' treatment with a novel inhaled phosphodiesterase type-4 inhibitor in COPD. Eur Respir J. 2009 May;33(5):1039-44. doi: 10.1183/09031936.00068908. Epub 2009 Feb 12.
- 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
28 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing UK-500,001 in people with Pulmonary Disease, Chronic Obstructive, run by Pfizer at 28 sites in 10 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: stopped early, as of the sponsor's last update on 23 Jul 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in Argentina, Canada, Czechia, Australia, Chile and 5 more countries. 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 was stopped early (reason given: The decision to terminate was completely related to efficacy and there were no safety concerns.). Results are not available in the source record.
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 forced expiratory volume in 1 second (FEV1) compared to placebo. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00263874, which also lists 1 linked publication.
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 23 Jul 2007.