Clinical trial NCT01321463: Study To Evaluate The Efficacy And Safety Of PH-797804 For 12 Weeks In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD) Taking Salmeterol Xinafoate/Fluticasone Propionate Combination
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 For 12 Weeks In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD) On A Background Of Salmeterol Xinafoate/ Fluticasone Propionate Combination
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-03-23
Enrollment: 377
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 an oral 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 a smoking history of at least 10 pack-years and be current smokers or ex-smokers that gave up \> 6 months ago.
* Subjects must be treated with a LABA/ICS combination for at least 1 month prior to screening.

Exclusion Criteria:

* A COPD exacerbation requiring treatment with oral steroids or hospitalization for the treatment of COPD within 3 months of screening.
* 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: Spirometry measures during 12 weeks of treatment and up to 2 weeks post treatment.
timeFrame: 12 Weeks
Secondary outcomes:
measure: Safety and tolerability measures (AEs, 12-lead ECG, lab safety) during 12 weeks of treatment and up to 2 weeks post treatment.
timeFrame: 12 Weeks
measure: Dyspnea index scores.
timeFrame: 12 Weeks
measure: Rescue bronchodilator usage.
timeFrame: 12 Weeks
measure: Symptom scores.
timeFrame: 12 Weeks
measure: Global impression of change (patient and clinician).
timeFrame: 12 Weeks
measure: Blood sample for pharmacokinetics.
timeFrame: 12 Weeks
measure: Blood and urine sample for biomarkers and molecular profiling.
timeFrame: 12 Weeks
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: Glendale
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Clearwater
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Pensacola
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Trinity
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Conyers
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Duluth
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Norcross
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Livonia
country: United States
facility: Pfizer Investigational Site
state: Michigan
city: Fridley
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Minneapolis
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: St. Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Lincoln
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: Spartanburg
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Mckinney
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Capital Federal
country: Argentina
facility: Pfizer Investigational Site
state: Buenos Aires
city: Rosario
country: Argentina
facility: Pfizer Investigational Site
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Daw Park
country: Australia
facility: Pfizer Investigational Site
state: South Australia
city: Nedlands
country: Australia
facility: Pfizer Investigational Site
state: Western Australia
city: Ruse
country: Bulgaria
facility: Pfizer Investigational Site
city: Sevlievo
country: Bulgaria
facility: Pfizer Investigational Site
city: Sofia
country: Bulgaria
facility: Pfizer Investigational Site
city: Sofia
country: Bulgaria
facility: Pfizer Investigational Site
city: Stara Zagora
country: Bulgaria
facility: Pfizer Investigational Site
city: Calgary
country: Canada
facility: Pfizer Investigational Site
state: Alberta
city: Niagara Falls
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Trois-Rivieres
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Quebec
country: Canada
facility: Pfizer Investigational Site
city: Quillota
country: Chile
facility: Pfizer Investigational Site
state: V Region
city: Valparaiso
country: Chile
facility: Pfizer Investigational Site
state: V Region
city: Kutna Hora
country: Czech Republic
facility: Pfizer Investigational Site
city: Liberec
country: Czech Republic
facility: Pfizer Investigational Site
city: Pardubice
country: Czech Republic
facility: Pfizer Investigational Site
city: Praha 10- Malesice
country: Czech Republic
facility: Pfizer Investigational Site
city: Tabor
country: Czech Republic
facility: Pfizer Investigational Site
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Gyula
country: Hungary
facility: Pfizer Investigational Site
city: Szeged
country: Hungary
facility: Pfizer Investigational Site
city: Szombathely
country: Hungary
facility: Pfizer Investigational Site
city: Ahmedabad
country: India
facility: Pfizer Investigational Site
state: Gujarat
city: Nagpur
country: India
facility: Pfizer Investigational Site
state: Maharashtra
city: Coimbatore
country: India
facility: Pfizer Investigational Site
state: Tamil Nadu
city: Newtown
country: New Zealand
facility: Pfizer Investigational Site
city: Tauranga
country: New Zealand
facility: Pfizer Investigational Site
city: Leczna
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Zawadzkie
country: Poland
facility: Pfizer Investigational Site
city: Bojnice
country: Slovakia
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Kosice
country: Slovakia
facility: Pfizer Investigational Site
city: Liptovsky Hradok
country: Slovakia
facility: Pfizer Investigational Site
city: Povazska Bystrica
country: Slovakia
facility: Pfizer Investigational Site
city: Spisska Nova Ves
country: Slovakia
facility: Pfizer Investigational Site
city: Bellville
country: South Africa
facility: Pfizer Investigational Site
state: Cape Town
city: Tygerberg Campus
country: South Africa
facility: Pfizer Investigational Site
state: Cape Town
city: Amanzimtoti
country: South Africa
facility: Pfizer Investigational Site
state: Durban
city: Durban
country: South Africa
facility: Pfizer Investigational Site
state: Kwa-Zulu Natal
city: Bloemfontein
country: South Africa
facility: Pfizer Investigational Site
city: Goteborg
country: Sweden
facility: Pfizer Investigational Site
city: Goteborg
country: Sweden
facility: Pfizer Investigational Site
city: Lund
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Cottingham
country: United Kingdom
facility: Pfizer Investigational Site
state: Hull
city: Glasgow
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: