Pulmonary Disease, Chronic ObstructivePhase 1/2NCT00163098
A Study of UK-369,003 on the Safety and Efficacy in Patients With COPD
A Phase 1/2 study testing UK-369,003 in people with Pulmonary Disease, Chronic Obstructive, run by Pfizer at 28 sites in 6 countries.
Trial summary
A randomised, controlled study investigating the effect of UK-369,003 on exercise tolerance in patients with COPD Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- UK-369,003
- How many people
- 136 participants
- Where
- 28 sitesin 6 countries
- Study dates
- Dec 2004to Dec 2005
- Phase
- Phase 1/2
- 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 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- GOLD criteria 2 to 4
- 10 pack year history of smoking
Who cannot join
- Women of child bearing potential
Trial locations and contacts
28 sites in 6 countries.
28 sites in 6 countries
Argentina11 sites
Pfizer Investigational Site
Buenos Aires, 1272
Pfizer Investigational Site
Buenos Aires, 1427
Pfizer Investigational Site
Ciudad de Beurnos Aires, C1425DQi
Pfizer Investigational Site
Ciudad de Buenos Aires, C1115AAB
Pfizer Investigational Site
Ciudad de Buenos Aires, C1416DRV
Pfizer Investigational Site
Ciudad de Buenos Aires,, (C1425DTG)
Pfizer Investigational Site
Córdoba, Córdoba Province, CP 5016
Pfizer Investigational Site
Provincia de Buenos Aires, (1605)
Pfizer Investigational Site
Rosario, Santa Fé, 2000
Pfizer Investigational Site
San Miguel de Tucumán, Pcia de Tucuman, 4000
Pfizer Investigational Site
San Miguel de Tucumán, Pcia de Tucuman
Australia6 sites
Pfizer Investigational Site
Adelaide, South Australia, 5000
Pfizer Investigational Site
Camperdown, New South Wales, 2050
Pfizer Investigational Site
Chermside, Queensland, 4032
Pfizer Investigational Site
Darlinghurst, New South Wales, 2010
Pfizer Investigational Site
Melbourne, Victoria, 3004
Pfizer Investigational Site
Perth, Western Australia, 6000
India5 sites
Pfizer Investigational Site
Chennai, Tamil Nadu, 600116
Pfizer Investigational Site
Kochi, Kerala, 682026
Pfizer Investigational Site
Mumbai, Maharashtra, 400016
Pfizer Investigational Site
Pune, Maharashtra, 411 019
Pfizer Investigational Site
Vellore, Tamil Nadu, 632002
United Kingdom3 sites
Pfizer Investigational Site
Glasgow, G11 6NT
Pfizer Investigational Site
Newcastle upon Tyne, NE7 7DN
Pfizer Investigational Site
Papworth Everard, Cambridgeshire, CB3 8RE
Germany2 sites
Pfizer Investigational Site
Giessen, 35392
Pfizer Investigational Site
Greifestein, 35753
Location not given1 site
Pfizer Investigational Site
About this study
Official title: A Multi-Centre, Multinational, Randomized, Double-Blind, Placebo Controlled, Proof Of Concept Trial To Assess The Effects Of A Subject-Optimized Dose Of UK-369,003 On Exercise Capacity In Subjects With Chronic Obstructive Pulmonary Disease
A randomised, controlled study investigating the effect of UK-369,003 on exercise tolerance in patients with COPD
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- UK-369,003
- 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-369,003Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect on exercise tolerance
Secondary outcomes (1)
Effect on lung function and quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2005 (estimated)
- Study startDec 2004
- Study completionDec 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 136 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
- NCT00163098
- Sponsor's protocol ID
- A3711028
- Status last verified
- Oct 2006
- First submitted
- 8 Sep 2005
- Last updated
- 13 Oct 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Centre, Multinational, Randomized, Double-Blind, Placebo Controlled, Proof Of Concept Trial To Assess The Effects Of A Subject-Optimized Dose Of UK-369,003 On Exercise Capacity In Subjects With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT00163098
- Acronym / sponsor ID
- A3711028
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Study completion
- Dec 2005
- First posted
- 13 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.
A randomised, controlled study investigating the effect of UK-369,003 on exercise tolerance in patients with COPD
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- GOLD criteria 2 to 4
- 10 pack year history of smoking
Key exclusion criteria (1 listed)
- Women of child bearing potential
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-369,003 | Drug | – |
Primary outcome
Effect on exercise tolerance
1 secondary outcome
Effect on lung function and quality of life
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 13 Oct 2006.
- 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 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing UK-369,003 in people with Pulmonary Disease, Chronic Obstructive, run by Pfizer at 28 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 1 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 13 Oct 2006. 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, Australia, India, United Kingdom, Germany. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Effect on exercise tolerance. 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 13 Oct 2006.