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:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01321463
First received: March 21, 2011
Last updated: July 25, 2012
Last verified: July 2012
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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
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| 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 25, 2012 |
| 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 May 23, 2013