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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00559910




Registration number
NCT00559910
Ethics application status
Date submitted
15/11/2007
Date registered
16/11/2007
Date last updated
16/10/2018

Titles & IDs
Public title
A Phase II, Study To Evaluate The Efficacy And Safety Of PH-797804 In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD).
Scientific title
A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Once-Daily Orally Administered PH-797804 (0.5, 3, 6 And 10 MG) In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD).
Secondary ID [1] 0 0
A6631011
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 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
Treatment: Drugs - PH-797804
Treatment: Drugs - Placebo

Experimental: PH-797804 - PH-797804 at four dose levels

Placebo comparator: Placebo - Placebo


Treatment: Drugs: PH-797804
PH-797804 at four dose levels

Treatment: Drugs: Placebo
Placebo
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability measures (AEs, 12-lead ECG, lab safety) during 6 weeks of treatment and up to 2 weeks post treatment.
Timepoint [1] 0 0
6 weeks
Primary outcome [2] 0 0
Spirometry measures during 6 weeks of treatment and up to 2 weeks post treatment.
Timepoint [2] 0 0
6 weeks
Secondary outcome [1] 0 0
Peak expiratory flow rate.
Timepoint [1] 0 0
6 weeks
Secondary outcome [2] 0 0
Blood sample for pharmacogenomics
Timepoint [2] 0 0
6 weeks
Secondary outcome [3] 0 0
Blood sample for pharmacokinetics
Timepoint [3] 0 0
6 weeks
Secondary outcome [4] 0 0
Rescue bronchodilator usage.
Timepoint [4] 0 0
6 weeks
Secondary outcome [5] 0 0
Dyspnea index scores.
Timepoint [5] 0 0
6 weeks
Secondary outcome [6] 0 0
Global impression of change (patient and clinician).
Timepoint [6] 0 0
6 weeks
Secondary outcome [7] 0 0
Symptom scores.
Timepoint [7] 0 0
6 weeks
Secondary outcome [8] 0 0
Blood sample for biomarkers
Timepoint [8] 0 0
6 weeks

Eligibility
Key inclusion criteria
* Male or female subjects between, and including, the ages of 40 and 80 years.
* Subjects with a diagnosis, for at least 6 months, of moderate to severe COPD (GOLD) and who meet the criteria for Stage II-III disease, subjects must have had stable disease for at least 1 month prior to screening.
* Subjects must have a smoking history of at least 10 pack-years and be current smokers or ex-smokers that gave up > 6 months ago.
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* More than 2 exacerbations of COPD requiring treatment with oral steroids in the preceding year or hospitalization for the treatment of COPD within 3 months of screening or more than twice during the preceding year.
* History or presence of significant cardiovascular disease.
* ECG abnormalities.
* Significant concomitant clinical disease that could interfere with the conduct, safety or interpretation of results of this study.
* Evidence of organ or blood disorders.

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?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/02/2008
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/12/2009
Sample size
Target
Accrual to date
Final
230
Recruitment in Australia
Recruitment state(s)
NSW,SA,WA
Recruitment hospital [1] 0 0
Pfizer Investigational Site - Camperdown
Recruitment hospital [2] 0 0
Pfizer Investigational Site - Daw Park
Recruitment hospital [3] 0 0
Pfizer Investigational Site - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
5041 - Daw Park
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
Capital Federal
Country [3] 0 0
Argentina
State/province [3] 0 0
Santa Fe
Country [4] 0 0
Canada
State/province [4] 0 0
British Columbia
Country [5] 0 0
Canada
State/province [5] 0 0
Manitoba
Country [6] 0 0
Canada
State/province [6] 0 0
Ontario
Country [7] 0 0
Canada
State/province [7] 0 0
Quebec
Country [8] 0 0
Chile
State/province [8] 0 0
Santiago, RM
Country [9] 0 0
Chile
State/province [9] 0 0
V Región
Country [10] 0 0
Chile
State/province [10] 0 0
Talca
Country [11] 0 0
Czechia
State/province [11] 0 0
Cvikov
Country [12] 0 0
Czechia
State/province [12] 0 0
Kutna Hora
Country [13] 0 0
Czechia
State/province [13] 0 0
Liberec
Country [14] 0 0
Czechia
State/province [14] 0 0
Praha 5
Country [15] 0 0
Czechia
State/province [15] 0 0
Strakonice
Country [16] 0 0
Czechia
State/province [16] 0 0
Tabor
Country [17] 0 0
France
State/province [17] 0 0
Lille
Country [18] 0 0
France
State/province [18] 0 0
Marseille
Country [19] 0 0
France
State/province [19] 0 0
Montpellier
Country [20] 0 0
France
State/province [20] 0 0
Perpignan
Country [21] 0 0
Greece
State/province [21] 0 0
Athens
Country [22] 0 0
Greece
State/province [22] 0 0
Heraklion
Country [23] 0 0
Greece
State/province [23] 0 0
Larissa
Country [24] 0 0
Hungary
State/province [24] 0 0
Budapest
Country [25] 0 0
Hungary
State/province [25] 0 0
Deszk
Country [26] 0 0
Hungary
State/province [26] 0 0
Pecs
Country [27] 0 0
Hungary
State/province [27] 0 0
Szombathely
Country [28] 0 0
Korea, Republic of
State/province [28] 0 0
Anyang
Country [29] 0 0
Korea, Republic of
State/province [29] 0 0
Seoul
Country [30] 0 0
Netherlands
State/province [30] 0 0
Almere
Country [31] 0 0
Netherlands
State/province [31] 0 0
Zutphen
Country [32] 0 0
Russian Federation
State/province [32] 0 0
Yaroslavl
Country [33] 0 0
South Africa
State/province [33] 0 0
Kwa-Zulu Natal
Country [34] 0 0
South Africa
State/province [34] 0 0
Bloemfontein
Country [35] 0 0
South Africa
State/province [35] 0 0
Durban
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Edinburgh

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

Ethics approval
Ethics application status

Summary
Brief summary
PH-797804 is a potent ant-inflammatory drug that may reduce the inflammation that is associated with COPD. PH-797804 will be dosed to patients with COPD to evaluate its potential safety and efficacy profile in COPD.
Trial website
https://clinicaltrials.gov/study/NCT00559910
Trial related presentations / publications
MacNee W, Allan RJ, Jones I, De Salvo MC, Tan LF. Efficacy and safety of the oral p38 inhibitor PH-797804 in chronic obstructive pulmonary disease: a randomised clinical trial. Thorax. 2013 Aug;68(8):738-45. doi: 10.1136/thoraxjnl-2012-202744. Epub 2013 Mar 28.
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/NCT00559910