Clinical trial NCT00559910: A Phase II, Study To Evaluate The Efficacy And Safety Of PH-797804 In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD).
Official 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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2007-11-16
Enrollment: 230
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

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.

Primary outcomes:
measure: Safety and tolerability measures (AEs, 12-lead ECG, lab safety) during 6 weeks of treatment and up to 2 weeks post treatment.
timeFrame: 6 weeks
measure: Spirometry measures during 6 weeks of treatment and up to 2 weeks post treatment.
timeFrame: 6 weeks
Secondary outcomes:
measure: Peak expiratory flow rate.
timeFrame: 6 weeks
measure: Blood sample for pharmacogenomics
timeFrame: 6 weeks
measure: Blood sample for pharmacokinetics
timeFrame: 6 weeks
measure: Rescue bronchodilator usage.
timeFrame: 6 weeks
measure: Dyspnea index scores.
timeFrame: 6 weeks
measure: Global impression of change (patient and clinician).
timeFrame: 6 weeks
measure: Symptom scores.
timeFrame: 6 weeks
measure: Blood sample for biomarkers
timeFrame: 6 weeks
Other outcomes:
Locations:
city: La Plata
country: Argentina
facility: Pfizer Investigational Site
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
state: Capital Federal
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
state: Capital Federal
city: Ciudad Autonoma de Buenos Aires (CABA)
country: Argentina
facility: Pfizer Investigational Site
state: Capital Federal
city: Rosario
country: Argentina
facility: Pfizer Investigational Site
state: Santa Fe
city: Camperdown
country: Australia
facility: Pfizer Investigational Site
state: New South Wales
city: Daw Park
country: Australia
facility: Pfizer Investigational Site
state: South Australia
city: Nedlands
country: Australia
facility: Pfizer Investigational Site
state: Western Australia
city: Vancouver
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Winnipeg
country: Canada
facility: Pfizer Investigational Site
state: Manitoba
city: Hamilton
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Kingston
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Sainte-Foy
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Providencia
country: Chile
facility: Pfizer Investigational Site
state: Santiago, RM
city: Valparaiso
country: Chile
facility: Pfizer Investigational Site
state: V Región
city: Talca
country: Chile
facility: Pfizer Investigational Site
city: Cvikov
country: Czechia
facility: Pfizer Investigational Site
city: Kutna Hora
country: Czechia
facility: Pfizer Investigational Site
city: Liberec
country: Czechia
facility: Pfizer Investigational Site
city: Praha 5
country: Czechia
facility: Pfizer Investigational Site
city: Strakonice
country: Czechia
facility: Pfizer Investigational Site
city: Tabor
country: Czechia
facility: Pfizer Investigational Site
city: Lille
country: France
facility: Pfizer Investigational Site
city: Marseille
country: France
facility: Pfizer Investigational Site
city: Montpellier
country: France
facility: Pfizer Investigational Site
city: Perpignan
country: France
facility: Pfizer Investigational Site
city: Athens
country: Greece
facility: Pfizer Investigational Site
city: Heraklion
country: Greece
facility: Pfizer Investigational Site
city: Larissa
country: Greece
facility: Pfizer Investigational Site
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Deszk
country: Hungary
facility: Pfizer Investigational Site
city: Pecs
country: Hungary
facility: Pfizer Investigational Site
city: Szombathely
country: Hungary
facility: Pfizer Investigational Site
city: Anyang
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Seoul
country: Korea, Republic of
facility: Pfizer Investigational Site
city: Almere
country: Netherlands
facility: Pfizer Investigational Site
city: Zutphen
country: Netherlands
facility: Pfizer Investigational Site
city: Yaroslavl
country: Russian Federation
facility: Pfizer Investigational Site
city: Yaroslavl
country: Russian Federation
facility: Pfizer Investigational Site
city: Durban
country: South Africa
facility: Pfizer Investigational Site
state: Kwa-Zulu Natal
city: Bloemfontein
country: South Africa
facility: Pfizer Investigational Site
city: Durban
country: South Africa
facility: Pfizer Investigational Site
city: Edinburgh
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.