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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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).
Secondary ID [1] 0 0
A5641009
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pulmonary Disease, Chronic Obstructive 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline in forced expiratory volume in 1 second (FEV1) compared to placebo
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Change from baseline in other lung function parameters, dyspnea, quality of life compared to placebo
Timepoint [1] 0 0

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
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Any significant co-morbid disease
* Use of any maintenance therapy except short acting bronchodilators

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Camperdown
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Clayton
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3168a - Clayton
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
Argentina
State/province [1] 0 0
Buenos Aires
Country [2] 0 0
Argentina
State/province [2] 0 0
Santa Fé
Country [3] 0 0
Canada
State/province [3] 0 0
Alberta
Country [4] 0 0
Canada
State/province [4] 0 0
Ontario
Country [5] 0 0
Chile
State/province [5] 0 0
RM
Country [6] 0 0
Chile
State/province [6] 0 0
Santiago
Country [7] 0 0
Chile
State/province [7] 0 0
ValparaÃ-so
Country [8] 0 0
Croatia
State/province [8] 0 0
Zagreb
Country [9] 0 0
Czech Republic
State/province [9] 0 0
Olomouc
Country [10] 0 0
Czech Republic
State/province [10] 0 0
Ostrava-Poruba
Country [11] 0 0
Czech Republic
State/province [11] 0 0
Praha 5
Country [12] 0 0
Czech Republic
State/province [12] 0 0
Tabor
Country [13] 0 0
Hungary
State/province [13] 0 0
Debrecen
Country [14] 0 0
Hungary
State/province [14] 0 0
Torokbalint
Country [15] 0 0
Hungary
State/province [15] 0 0
Veszprem
Country [16] 0 0
Singapore
State/province [16] 0 0
Singapore
Country [17] 0 0
Spain
State/province [17] 0 0
Madrid
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Manchester

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Pfizer
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT00263874
Trial related presentations / 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.
Public notes

Contacts
Principal investigator
Name 0 0
Pfizer CT.gov Call Center
Address 0 0
Pfizer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00263874