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

NCT01321463 | Completed Phase 2 DMC

• 1 other identifier: A6631029
• Study Type: interventional
• Target: 377
• Locations: 15 countries
• Sites: 74

Brief Summary

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Spirometry measures during 12 weeks of treatment and up to 2 weeks post treatment.

  12 Weeks

Secondary Outcomes (7)

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

  12 Weeks

• Dyspnea index scores.

  12 Weeks

• Rescue bronchodilator usage.

  12 Weeks

• Symptom scores.

  12 Weeks

• Global impression of change (patient and clinician).

  12 Weeks

Study Arms (2)

PH-797804

EXPERIMENTAL

Drug: PH-797804

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

PH-797804 DRUG

6 mg oral tablet once daily for 12 weeks

PH-797804

Placebo DRUG

Placebo oral tablet once daily for 12 weeks

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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (74)

Pfizer Investigational Site

Mobile, Alabama, 36608, United States

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Glendale, Arizona, 85306, United States

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San Diego, California, 92120, United States

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Clearwater, Florida, 33756, United States

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Pensacola, Florida, 32504, United States

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Tampa, Florida, 33603, United States

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Tampa, Florida, 33613, United States

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Trinity, Florida, 34655, United States

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Conyers, Georgia, 30094, United States

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Duluth, Georgia, 30096, United States

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Norcross, Georgia, 30071, United States

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Livonia, Michigan, 48152, United States

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Fridley, Minnesota, 55432, United States

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Minneapolis, Minnesota, 55407, United States

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Rochester, Minnesota, 55905, United States

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St Louis, Missouri, 63141, United States

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Cincinnati, Ohio, 45231, United States

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Cincinnati, Ohio, 45245, United States

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Lincoln, Rhode Island, 02865, United States

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Spartanburg, South Carolina, 29303, United States

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Houston, Texas, 77030, United States

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McKinney, Texas, 75069, United States

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Capital Federal, Buenos Aires, C1440BRR, Argentina

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Rosario, Santa Fe Province, 2000, Argentina

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Buenos Aires, 1426, Argentina

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Daw Park, South Australia, 5041, Australia

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Nedlands, Western Australia, 6009, Australia

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Rousse, 7002, Bulgaria

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Sevlievo, 5400, Bulgaria

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Sofia, 1407, Bulgaria

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Sofia, 1431, Bulgaria

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Stara Zagora, 6003, Bulgaria

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Calgary, Alberta, T1Y 6J4, Canada

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Niagara Falls, Ontario, L2G 1J4, Canada

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Ottawa, Ontario, K1Y 4G2, Canada

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Toronto, Ontario, M6H 3M2, Canada

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Québec, Quebec, G1V 4G5, Canada

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Trois-Rivières, Quebec, G8T 7A1, Canada

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Quillota, Región de Valparaíso, 2260494, Chile

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Valparaíso, Región de Valparaíso, 2352499, Chile

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Kutná Hora, 284 01, Czechia

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Liberec, 460 01, Czechia

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Pardubice, 530 09, Czechia

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Praha 10- Malesice, 108 00, Czechia

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Tábor, 39001, Czechia

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Budapest, 1125, Hungary

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Gyula, 5703, Hungary

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Szeged, 6722, Hungary

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Szombathely, 9700, Hungary

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Ahmedabad, Gujarat, 380 052, India

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Nagpur, Maharashtra, 440 012, India

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Coimbatore, Tamil Nadu, 641 004, India

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Newtown, 6021, New Zealand

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Tauranga, 3110, New Zealand

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Warsaw, 04-141, Poland

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Zawadzkie, 47-120, Poland

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Łęczna, 21-010, Poland

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Bojnice, 972 01, Slovakia

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Bratislava, 826 06, Slovakia

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Košice, 040 01, Slovakia

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Liptovský Hrádok, 033 01, Slovakia

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Považská Bystrica, 017 26, Slovakia

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Spišská Nová Ves, 052 01, Slovakia

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Bellville, Cape Town, 7530, South Africa

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Tygerberg Campus, Cape Town, 7505, South Africa

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eManzimtoti, Durban, 4126, South Africa

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Durban, KwaZulu-Natal, 4001, South Africa

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Bloemfontein, 9301, South Africa

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Gothenburg, 400 14, Sweden

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Gothenburg, 413 45, Sweden

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Lund, 22185, Sweden

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Stockholm, 171 76, Sweden

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Cottingham, Hull, HU16 5JQ, United Kingdom

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Glasgow, G12 OYN, United Kingdom

Location

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2011
• First Posted: March 23, 2011
• Study Start: May 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: July 11, 2013

Record last verified: 2012-07

Locations

BU (5); SE (4); CL (2); PL (3); AU (2); CZ (5); US (22); IN (3); SL (6); GB (2); AR (3); HU (4); CA (6); NZ (2); ZA (5)