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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00263874
Registration number
NCT00263874
Ethics application status
Date submitted
8/12/2005
Date registered
9/12/2005
Date last updated
23/07/2007
Titles & IDs
Public title
Phase 2 Study of the Safety and Efficacy of UK-500,001 in Adult Patients With COPD
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Scientific 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).
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Secondary ID [1]
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A5641009
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pulmonary Disease, Chronic Obstructive
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Condition category
Condition code
Respiratory
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Chronic obstructive pulmonary disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - UK-500,001
Treatment: Drugs: UK-500,001
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change from baseline in forced expiratory volume in 1 second (FEV1) compared to placebo
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Assessment method [1]
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Timepoint [1]
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Secondary outcome [1]
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Change from baseline in other lung function parameters, dyspnea, quality of life compared to placebo
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Assessment method [1]
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Timepoint [1]
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Eligibility
Key inclusion criteria
- Moderate-severe COPD (Global inititiative for chronic Obstructive Lung Disease, GOLD,
2003 definition)
- Smoking history of at least 10 pack-years
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Minimum age
40
Years
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Maximum age
80
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Any significant co-morbid disease
- Use of any maintenance therapy except short acting bronchodilators
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Terminated
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/11/2005
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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Recruitment hospital [1]
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Pfizer Investigational Site - Camperdown
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Recruitment hospital [2]
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Pfizer Investigational Site - Clayton
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Recruitment hospital [3]
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Pfizer Investigational Site - Nedlands
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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3168a - Clayton
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Recruitment postcode(s) [3]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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Argentina
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State/province [1]
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Buenos Aires
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Argentina
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Santa Fé
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Canada
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Alberta
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Canada
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Ontario
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Chile
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RM
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Chile
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Santiago
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Chile
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ValparaÃ-so
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Croatia
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Zagreb
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Czech Republic
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Olomouc
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Czech Republic
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Ostrava-Poruba
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Czech Republic
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Praha 5
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Czech Republic
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Tabor
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Hungary
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Debrecen
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Hungary
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Torokbalint
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Hungary
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Veszprem
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Singapore
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Singapore
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Spain
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Madrid
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Country [18]
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United Kingdom
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State/province [18]
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Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Pfizer
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00263874
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Pfizer CT.gov Call Center
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Address
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Pfizer
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00263874
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