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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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
Gender
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
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,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/show/NCT00559910
Trial related presentations / publications
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
Other publications