A Phase II, Study To Evaluate The Efficacy And Safety Of PH-797804 In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD).

Chronic Obstructive Pulmonary Disease Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00559910
• Other study ID #: A6631011
• Status: Completed
• Phase: Phase 2
• Start date: February 2008
• Est. completion date: December 2009

Study information

• Verified date: October 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• PH-797804
PH-797804 at four dose levels
• Placebo
Placebo

Locations

Country	Name	City	State
Argentina	Pfizer Investigational Site	Buenos Aires	Capital Federal
Argentina	Pfizer Investigational Site	Buenos Aires	Capital Federal
Argentina	Pfizer Investigational Site	Ciudad Autonoma de Buenos Aires (CABA)	Capital Federal
Argentina	Pfizer Investigational Site	La Plata	Buenos Aires
Argentina	Pfizer Investigational Site	Rosario	Santa Fe
Australia	Pfizer Investigational Site	Camperdown	New South Wales
Australia	Pfizer Investigational Site	Daw Park	South Australia
Australia	Pfizer Investigational Site	Nedlands	Western Australia
Canada	Pfizer Investigational Site	Hamilton	Ontario
Canada	Pfizer Investigational Site	Kingston	Ontario
Canada	Pfizer Investigational Site	Sainte-Foy	Quebec
Canada	Pfizer Investigational Site	Vancouver	British Columbia
Canada	Pfizer Investigational Site	Winnipeg	Manitoba
Chile	Pfizer Investigational Site	Providencia	Santiago, RM
Chile	Pfizer Investigational Site	Talca
Chile	Pfizer Investigational Site	Valparaiso	V Región
Czechia	Pfizer Investigational Site	Cvikov
Czechia	Pfizer Investigational Site	Kutna Hora
Czechia	Pfizer Investigational Site	Liberec
Czechia	Pfizer Investigational Site	Praha 5
Czechia	Pfizer Investigational Site	Strakonice
Czechia	Pfizer Investigational Site	Tabor
France	Pfizer Investigational Site	Lille
France	Pfizer Investigational Site	Marseille
France	Pfizer Investigational Site	Montpellier
France	Pfizer Investigational Site	Perpignan
Greece	Pfizer Investigational Site	Athens
Greece	Pfizer Investigational Site	Heraklion
Greece	Pfizer Investigational Site	Larissa
Hungary	Pfizer Investigational Site	Budapest
Hungary	Pfizer Investigational Site	Budapest
Hungary	Pfizer Investigational Site	Deszk
Hungary	Pfizer Investigational Site	Pecs
Hungary	Pfizer Investigational Site	Szombathely
Korea, Republic of	Pfizer Investigational Site	Anyang
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Netherlands	Pfizer Investigational Site	Almere
Netherlands	Pfizer Investigational Site	Zutphen
Russian Federation	Pfizer Investigational Site	Yaroslavl
Russian Federation	Pfizer Investigational Site	Yaroslavl
South Africa	Pfizer Investigational Site	Bloemfontein
South Africa	Pfizer Investigational Site	Durban
South Africa	Pfizer Investigational Site	Durban	Kwa-Zulu Natal
United Kingdom	Pfizer Investigational Site	Edinburgh

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

Argentina,  Australia,  Canada,  Chile,  Czechia,  France,  Greece,  Hungary,  Korea, Republic of,  Netherlands,  Russian Federation,  South Africa,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability measures (AEs, 12-lead ECG, lab safety) during 6 weeks of treatment and up to 2 weeks post treatment.		6 weeks
Primary	Spirometry measures during 6 weeks of treatment and up to 2 weeks post treatment.		6 weeks
Secondary	Peak expiratory flow rate.		6 weeks
Secondary	Blood sample for pharmacogenomics		6 weeks
Secondary	Blood sample for pharmacokinetics		6 weeks
Secondary	Rescue bronchodilator usage.		6 weeks
Secondary	Dyspnea index scores.		6 weeks
Secondary	Global impression of change (patient and clinician).		6 weeks
Secondary	Symptom scores.		6 weeks
Secondary	Blood sample for biomarkers		6 weeks

External Links

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