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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00559910
Recruitment Status : Completed
First Posted : November 16, 2007
Last Update Posted : October 16, 2018
Sponsor:
Information provided by:
Pfizer

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: PH-797804 Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : February 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arms and Interventions
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Arm Intervention/treatment
Experimental: PH-797804
PH-797804 at four dose levels
 Drug: PH-797804
PH-797804 at four dose levels
Placebo Comparator: Placebo
Placebo
 Drug: Placebo
Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Safety and tolerability measures (AEs, 12-lead ECG, lab safety) during 6 weeks of treatment and up to 2 weeks post treatment. [ Time Frame: 6 weeks ]
  2. Spirometry measures during 6 weeks of treatment and up to 2 weeks post treatment. [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Peak expiratory flow rate. [ Time Frame: 6 weeks ]
  2. Blood sample for pharmacogenomics [ Time Frame: 6 weeks ]
  3. Blood sample for pharmacokinetics [ Time Frame: 6 weeks ]
  4. Rescue bronchodilator usage. [ Time Frame: 6 weeks ]
  5. Dyspnea index scores. [ Time Frame: 6 weeks ]
  6. Global impression of change (patient and clinician). [ Time Frame: 6 weeks ]
  7. Symptom scores. [ Time Frame: 6 weeks ]
  8. Blood sample for biomarkers [ Time Frame: 6 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00559910


Locations
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Argentina
Pfizer Investigational Site
La Plata, Buenos Aires, Argentina, 1900
Pfizer Investigational Site
Buenos Aires, Capital Federal, Argentina, C1425DQI
Pfizer Investigational Site
Buenos Aires, Capital Federal, Argentina, C1426ABP
Pfizer Investigational Site
Ciudad Autonoma de Buenos Aires (CABA), Capital Federal, Argentina, C1428DDE
Pfizer Investigational Site
Rosario, Santa Fe, Argentina, 2000
Australia, New South Wales
Pfizer Investigational Site
Camperdown, New South Wales, Australia, 2050
Australia, South Australia
Pfizer Investigational Site
Daw Park, South Australia, Australia, 5041
Australia, Western Australia
Pfizer Investigational Site
Nedlands, Western Australia, Australia, 6009
Canada, British Columbia
Pfizer Investigational Site
Vancouver, British Columbia, Canada, V5Z 4E1
Canada, Manitoba
Pfizer Investigational Site
Winnipeg, Manitoba, Canada, R2K 3S8
Canada, Ontario
Pfizer Investigational Site
Hamilton, Ontario, Canada, L8N 3Z5
Pfizer Investigational Site
Kingston, Ontario, Canada, K7L 2V7
Canada, Quebec
Pfizer Investigational Site
Sainte-Foy, Quebec, Canada, G1V 4G5
Chile
Pfizer Investigational Site
Providencia, Santiago, RM, Chile, 7500691
Pfizer Investigational Site
Valparaiso, V Región, Chile, 2352499
Pfizer Investigational Site
Talca, Chile, 3460001
Czechia
Pfizer Investigational Site
Cvikov, Czechia, 471 54
Pfizer Investigational Site
Kutna Hora, Czechia, 283 01
Pfizer Investigational Site
Liberec, Czechia, 460 01
Pfizer Investigational Site
Praha 5, Czechia, 153 00
Pfizer Investigational Site
Strakonice, Czechia, 387 01
Pfizer Investigational Site
Tabor, Czechia, 39001
France
Pfizer Investigational Site
Lille, France, 59042 CEDEX
Pfizer Investigational Site
Marseille, France, 13009
Pfizer Investigational Site
Montpellier, France, 34295 CEDEX 5
Pfizer Investigational Site
Perpignan, France, 66000
Greece
Pfizer Investigational Site
Athens, Greece, 10676
Pfizer Investigational Site
Heraklion, Greece, 711 10
Pfizer Investigational Site
Larissa, Greece, 41 110
Hungary
Pfizer Investigational Site
Budapest, Hungary, 1125
Pfizer Investigational Site
Budapest, Hungary, H-1036
Pfizer Investigational Site
Deszk, Hungary, 6772
Pfizer Investigational Site
Pecs, Hungary, 7626
Pfizer Investigational Site
Szombathely, Hungary, 9700
Korea, Republic of
Pfizer Investigational Site
Anyang, Korea, Republic of, 431-070
Pfizer Investigational Site
Seoul, Korea, Republic of, 135-710
Pfizer Investigational Site
Seoul, Korea, Republic of, 138-736
Netherlands
Pfizer Investigational Site
Almere, Netherlands, 1311 RL
Pfizer Investigational Site
Zutphen, Netherlands, 7207 BA
Russian Federation
Pfizer Investigational Site
Yaroslavl, Russian Federation, 150003
Pfizer Investigational Site
Yaroslavl, Russian Federation, 150023
South Africa
Pfizer Investigational Site
Durban, Kwa-Zulu Natal, South Africa, 4001
Pfizer Investigational Site
Bloemfontein, South Africa, 9301
Pfizer Investigational Site
Durban, South Africa, 4126
United Kingdom
Pfizer Investigational Site
Edinburgh, United Kingdom, EH16 4SA
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00559910    
Other Study ID Numbers: A6631011
First Posted: November 16, 2007    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases