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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01321463
First received: March 21, 2011
Last updated: July 8, 2013
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: PH-797804
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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 For 12 Weeks In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD) On A Background Of Salmeterol Xinafoate/ Fluticasone Propionate Combination

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Spirometry measures during 12 weeks of treatment and up to 2 weeks post treatment. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and tolerability measures (AEs, 12-lead ECG, lab safety) during 12 weeks of treatment and up to 2 weeks post treatment. [ Time Frame: 12 Weeks ] [ Designated as safety issue: Yes ]
  • Dyspnea index scores. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Rescue bronchodilator usage. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Symptom scores. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Global impression of change (patient and clinician). [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Blood sample for pharmacokinetics. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]
  • Blood and urine sample for biomarkers and molecular profiling. [ Time Frame: 12 Weeks ] [ Designated as safety issue: No ]

Enrollment: 377
Study Start Date: May 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PH-797804 Drug: PH-797804
6 mg oral tablet once daily for 12 weeks
Placebo Comparator: Placebo Drug: Placebo
Placebo oral tablet once daily for 12 weeks

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01321463

  Hide Study Locations
Locations
United States, Alabama
Pfizer Investigational Site
Mobile, Alabama, United States, 36608
United States, Arizona
Pfizer Investigational Site
Glendale, Arizona, United States, 85306
United States, California
Pfizer Investigational Site
San Diego, California, United States, 92120
United States, Florida
Pfizer Investigational Site
Clearwater, Florida, United States, 33756
Pfizer Investigational Site
Pensacola, Florida, United States, 32504
Pfizer Investigational Site
Tampa, Florida, United States, 33613
Pfizer Investigational Site
Tampa, Florida, United States, 33603
Pfizer Investigational Site
Trinity, Florida, United States, 34655
United States, Georgia
Pfizer Investigational Site
Conyers, Georgia, United States, 30094
Pfizer Investigational Site
Duluth, Georgia, United States, 30096
Pfizer Investigational Site
Norcross, Georgia, United States, 30071
United States, Michigan
Pfizer Investigational Site
Livonia, Michigan, United States, 48152
United States, Minnesota
Pfizer Investigational Site
Fridley, Minnesota, United States, 55432
Pfizer Investigational Site
Minneapolis, Minnesota, United States, 55407
Pfizer Investigational Site
Rochester, Minnesota, United States, 55905
United States, Missouri
Pfizer Investigational Site
St. Louis, Missouri, United States, 63141
United States, Ohio
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45245
Pfizer Investigational Site
Cincinnati, Ohio, United States, 45231
United States, Rhode Island
Pfizer Investigational Site
Lincoln, Rhode Island, United States, 02865
United States, South Carolina
Pfizer Investigational Site
Spartanburg, South Carolina, United States, 29303
United States, Texas
Pfizer Investigational Site
Houston, Texas, United States, 77030
Pfizer Investigational Site
Mckinney, Texas, United States, 75069
Argentina
Pfizer Investigational Site
Capital Federal, Buenos Aires, Argentina, C1440BRR
Pfizer Investigational Site
Rosario, Santa Fe, Argentina, 2000
Pfizer Investigational Site
Buenos Aires, Argentina, 1426
Australia, South Australia
Pfizer Investigational Site
Daw Park, South Australia, Australia, 5041
Australia, Western Australia
Pfizer Investigational Site
Nedlands, Western Australia, Australia, 6009
Bulgaria
Pfizer Investigational Site
Ruse, Bulgaria, 7002
Pfizer Investigational Site
Sevlievo, Bulgaria, 5400
Pfizer Investigational Site
Sofia, Bulgaria, 1431
Pfizer Investigational Site
Sofia, Bulgaria, 1407
Pfizer Investigational Site
Stara Zagora, Bulgaria, 6003
Canada, Alberta
Pfizer Investigational Site
Calgary, Alberta, Canada, T1Y 6J4
Canada, Ontario
Pfizer Investigational Site
Niagara Falls, Ontario, Canada, L2G 1J4
Pfizer Investigational Site
Ottawa, Ontario, Canada, K1Y 4G2
Pfizer Investigational Site
Toronto, Ontario, Canada, M6H 3M2
Canada, Quebec
Pfizer Investigational Site
Trois-Rivieres, Quebec, Canada, G8T 7A1
Canada
Pfizer Investigational Site
Quebec, Canada, G1V 4G5
Chile
Pfizer Investigational Site
Quillota, V Region, Chile, 2260494
Pfizer Investigational Site
Valparaiso, V Region, Chile, 2352499
Czech Republic
Pfizer Investigational Site
Kutna Hora, Czech Republic, 284 01
Pfizer Investigational Site
Liberec, Czech Republic, 460 01
Pfizer Investigational Site
Pardubice, Czech Republic, 530 09
Pfizer Investigational Site
Praha 10- Malesice, Czech Republic, 108 00
Pfizer Investigational Site
Tabor, Czech Republic, 39001
Hungary
Pfizer Investigational Site
Budapest, Hungary, 1125
Pfizer Investigational Site
Gyula, Hungary, 5703
Pfizer Investigational Site
Szeged, Hungary, 6722
Pfizer Investigational Site
Szombathely, Hungary, 9700
India
Pfizer Investigational Site
Ahmedabad, Gujarat, India, 380 052
Pfizer Investigational Site
Nagpur, Maharashtra, India, 440 012
Pfizer Investigational Site
Coimbatore, Tamil Nadu, India, 641 004
New Zealand
Pfizer Investigational Site
Newtown, New Zealand, 6021
Pfizer Investigational Site
Tauranga, New Zealand, 3110
Poland
Pfizer Investigational Site
Leczna, Poland, 21-010
Pfizer Investigational Site
Warszawa, Poland, 04-141
Pfizer Investigational Site
Zawadzkie, Poland, 47-120
Slovakia
Pfizer Investigational Site
Bojnice, Slovakia, 972 01
Pfizer Investigational Site
Bratislava, Slovakia, 826 06
Pfizer Investigational Site
Kosice, Slovakia, 040 01
Pfizer Investigational Site
Liptovsky Hradok, Slovakia, 033 01
Pfizer Investigational Site
Povazska Bystrica, Slovakia, 017 26
Pfizer Investigational Site
Spisska Nova Ves, Slovakia, 052 01
South Africa
Pfizer Investigational Site
Bellville, Cape Town, South Africa, 7530
Pfizer Investigational Site
Tygerberg Campus, Cape Town, South Africa, 7505
Pfizer Investigational Site
Amanzimtoti, Durban, South Africa, 4126
Pfizer Investigational Site
Durban, Kwa-Zulu Natal, South Africa, 4001
Pfizer Investigational Site
Bloemfontein, South Africa, 9301
Sweden
Pfizer Investigational Site
Goteborg, Sweden, 413 45
Pfizer Investigational Site
Goteborg, Sweden, 400 14
Pfizer Investigational Site
Lund, Sweden, 22185
Pfizer Investigational Site
Stockholm, Sweden, 171 76
United Kingdom
Pfizer Investigational Site
Cottingham, Hull, United Kingdom, HU16 5JQ
Pfizer Investigational Site
Glasgow, United Kingdom, G12 OYN
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01321463     History of Changes
Other Study ID Numbers: A6631029
Study First Received: March 21, 2011
Last Updated: July 8, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Respiratory Tract Diseases
Salmeterol
Albuterol
Fluticasone
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Tocolytic Agents
Reproductive Control Agents
Dermatologic Agents
Anti-Allergic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 17, 2014