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

NCT00559910 | Completed Phase 2 DMC

• 1 other identifier: A6631011
• Study Type: interventional
• Target: 230
• Locations: 13 countries
• Sites: 45

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (2)

• Safety and tolerability measures (AEs, 12-lead ECG, lab safety) during 6 weeks of treatment and up to 2 weeks post treatment.

  6 weeks

• Spirometry measures during 6 weeks of treatment and up to 2 weeks post treatment.

  6 weeks

Secondary Outcomes (8)

• Peak expiratory flow rate.

  6 weeks

• Blood sample for pharmacogenomics

  6 weeks

• Blood sample for pharmacokinetics

  6 weeks

• Rescue bronchodilator usage.

  6 weeks

• Dyspnea index scores.

  6 weeks

Study Arms (2)

PH-797804

EXPERIMENTAL

PH-797804 at four dose levels

Drug: PH-797804

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

PH-797804 DRUG

PH-797804 at four dose levels

PH-797804

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (45)

Pfizer Investigational Site

La Plata, Buenos Aires, 1900, Argentina

Location

Pfizer Investigational Site

Buenos Aires, Buenos Aires F.D., C1425DQI, Argentina

Location

Pfizer Investigational Site

Buenos Aires, Buenos Aires F.D., C1426ABP, Argentina

Location

Pfizer Investigational Site

Ciudad Autonoma de Buenos Aires (caba), Buenos Aires F.D., C1428DDE, Argentina

Location

Pfizer Investigational Site

Rosario, Santa Fe Province, 2000, Argentina

Location

Pfizer Investigational Site

Camperdown, New South Wales, 2050, Australia

Location

Pfizer Investigational Site

Daw Park, South Australia, 5041, Australia

Location

Pfizer Investigational Site

Nedlands, Western Australia, 6009, Australia

Location

Pfizer Investigational Site

Vancouver, British Columbia, V5Z 4E1, Canada

Location

Pfizer Investigational Site

Winnipeg, Manitoba, R2K 3S8, Canada

Location

Pfizer Investigational Site

Hamilton, Ontario, L8N 3Z5, Canada

Location

Pfizer Investigational Site

Kingston, Ontario, K7L 2V7, Canada

Location

Pfizer Investigational Site

Sainte-Foy, Quebec, G1V 4G5, Canada

Location

Pfizer Investigational Site

Valparaíso, Región de Valparaíso, 2352499, Chile

Location

Pfizer Investigational Site

Providencia, Santiago, RM, 7500691, Chile

Location

Pfizer Investigational Site

Talca, 3460001, Chile

Location

Pfizer Investigational Site

Cvikov, 471 54, Czechia

Location

Pfizer Investigational Site

Kutná Hora, 283 01, Czechia

Location

Pfizer Investigational Site

Liberec, 460 01, Czechia

Location

Pfizer Investigational Site

Prague, 153 00, Czechia

Location

Pfizer Investigational Site

Strakonice, 387 01, Czechia

Location

Pfizer Investigational Site

Tábor, 39001, Czechia

Location

Pfizer Investigational Site

Lille, 59042 CEDEX, France

Location

Pfizer Investigational Site

Marseille, 13009, France

Location

Pfizer Investigational Site

Montpellier, 34295 CEDEX 5, France

Location

Pfizer Investigational Site

Perpignan, 66000, France

Location

Pfizer Investigational Site

Athens, 10676, Greece

Location

Pfizer Investigational Site

Heraklion, 711 10, Greece

Location

Pfizer Investigational Site

Larissa, 41 110, Greece

Location

Pfizer Investigational Site

Budapest, 1125, Hungary

Location

Pfizer Investigational Site

Budapest, H-1036, Hungary

Location

Pfizer Investigational Site

Deszk, 6772, Hungary

Location

Pfizer Investigational Site

Pécs, 7626, Hungary

Location

Pfizer Investigational Site

Szombathely, 9700, Hungary

Location

Pfizer Investigational Site

Almere Stad, 1311 RL, Netherlands

Location

Pfizer Investigational Site

Zutphen, 7207 BA, Netherlands

Location

Pfizer Investigational Site

Yaroslavl, 150003, Russia

Location

Pfizer Investigational Site

Yaroslavl, 150023, Russia

Location

Pfizer Investigational Site

Durban, KwaZulu-Natal, 4001, South Africa

Location

Pfizer Investigational Site

Bloemfontein, 9301, South Africa

Location

Pfizer Investigational Site

Durban, 4126, South Africa

Location

Pfizer Investigational Site

Anyang, 431-070, South Korea

Location

Pfizer Investigational Site

Seoul, 135-710, South Korea

Location

Pfizer Investigational Site

Seoul, 138-736, South Korea

Location

Pfizer Investigational Site

Edinburgh, EH16 4SA, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 23539534 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

PH 797804

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 15, 2007
• First Posted: November 16, 2007
• Study Start: February 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: October 16, 2018

Record last verified: 2018-10

Locations

CA (5); CZ (6); GR (3); CL (3); NL (2); RU (2); KR (3); AR (5); FR (4); HU (5); AU (3); ZA (3); GB (1)