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

Pulmonary Disease, Chronic Obstructive Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01321463
• Other study ID #: A6631029
• Status: Completed
• Phase: Phase 2
• First received: March 21, 2011
• Last updated: July 8, 2013
• Start date: May 2011
• Est. completion date: June 2012

Study information

• Verified date: July 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 377
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• PH-797804
6 mg oral tablet once daily for 12 weeks
• Placebo
Placebo oral tablet once daily for 12 weeks

Locations

Country	Name	City	State
Argentina	Pfizer Investigational Site	Buenos Aires
Argentina	Pfizer Investigational Site	Capital Federal	Buenos Aires
Argentina	Pfizer Investigational Site	Rosario	Santa Fe
Australia	Pfizer Investigational Site	Daw Park	South Australia
Australia	Pfizer Investigational Site	Nedlands	Western Australia
Bulgaria	Pfizer Investigational Site	Ruse
Bulgaria	Pfizer Investigational Site	Sevlievo
Bulgaria	Pfizer Investigational Site	Sofia
Bulgaria	Pfizer Investigational Site	Sofia
Bulgaria	Pfizer Investigational Site	Stara Zagora
Canada	Pfizer Investigational Site	Calgary	Alberta
Canada	Pfizer Investigational Site	Niagara Falls	Ontario
Canada	Pfizer Investigational Site	Ottawa	Ontario
Canada	Pfizer Investigational Site	Quebec
Canada	Pfizer Investigational Site	Toronto	Ontario
Canada	Pfizer Investigational Site	Trois-Rivieres	Quebec
Chile	Pfizer Investigational Site	Quillota	V Region
Chile	Pfizer Investigational Site	Valparaiso	V Region
Czech Republic	Pfizer Investigational Site	Kutna Hora
Czech Republic	Pfizer Investigational Site	Liberec
Czech Republic	Pfizer Investigational Site	Pardubice
Czech Republic	Pfizer Investigational Site	Praha 10- Malesice
Czech Republic	Pfizer Investigational Site	Tabor
Hungary	Pfizer Investigational Site	Budapest
Hungary	Pfizer Investigational Site	Gyula
Hungary	Pfizer Investigational Site	Szeged
Hungary	Pfizer Investigational Site	Szombathely
India	Pfizer Investigational Site	Ahmedabad	Gujarat
India	Pfizer Investigational Site	Coimbatore	Tamil Nadu
India	Pfizer Investigational Site	Nagpur	Maharashtra
New Zealand	Pfizer Investigational Site	Newtown
New Zealand	Pfizer Investigational Site	Tauranga
Poland	Pfizer Investigational Site	Leczna
Poland	Pfizer Investigational Site	Warszawa
Poland	Pfizer Investigational Site	Zawadzkie
Slovakia	Pfizer Investigational Site	Bojnice
Slovakia	Pfizer Investigational Site	Bratislava
Slovakia	Pfizer Investigational Site	Kosice
Slovakia	Pfizer Investigational Site	Liptovsky Hradok
Slovakia	Pfizer Investigational Site	Povazska Bystrica
Slovakia	Pfizer Investigational Site	Spisska Nova Ves
South Africa	Pfizer Investigational Site	Amanzimtoti	Durban
South Africa	Pfizer Investigational Site	Bellville	Cape Town
South Africa	Pfizer Investigational Site	Bloemfontein
South Africa	Pfizer Investigational Site	Durban	Kwa-Zulu Natal
South Africa	Pfizer Investigational Site	Tygerberg Campus	Cape Town
Sweden	Pfizer Investigational Site	Goteborg
Sweden	Pfizer Investigational Site	Goteborg
Sweden	Pfizer Investigational Site	Lund
Sweden	Pfizer Investigational Site	Stockholm
United Kingdom	Pfizer Investigational Site	Cottingham	Hull
United Kingdom	Pfizer Investigational Site	Glasgow
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Clearwater	Florida
United States	Pfizer Investigational Site	Conyers	Georgia
United States	Pfizer Investigational Site	Duluth	Georgia
United States	Pfizer Investigational Site	Fridley	Minnesota
United States	Pfizer Investigational Site	Glendale	Arizona
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Lincoln	Rhode Island
United States	Pfizer Investigational Site	Livonia	Michigan
United States	Pfizer Investigational Site	Mckinney	Texas
United States	Pfizer Investigational Site	Minneapolis	Minnesota
United States	Pfizer Investigational Site	Mobile	Alabama
United States	Pfizer Investigational Site	Norcross	Georgia
United States	Pfizer Investigational Site	Pensacola	Florida
United States	Pfizer Investigational Site	Rochester	Minnesota
United States	Pfizer Investigational Site	San Diego	California
United States	Pfizer Investigational Site	Spartanburg	South Carolina
United States	Pfizer Investigational Site	St. Louis	Missouri
United States	Pfizer Investigational Site	Tampa	Florida
United States	Pfizer Investigational Site	Tampa	Florida
United States	Pfizer Investigational Site	Trinity	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Bulgaria,  Canada,  Chile,  Czech Republic,  Hungary,  India,  New Zealand,  Poland,  Slovakia,  South Africa,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spirometry measures during 12 weeks of treatment and up to 2 weeks post treatment.		12 Weeks	No
Secondary	Safety and tolerability measures (AEs, 12-lead ECG, lab safety) during 12 weeks of treatment and up to 2 weeks post treatment.		12 Weeks	Yes
Secondary	Dyspnea index scores.		12 Weeks	No
Secondary	Rescue bronchodilator usage.		12 Weeks	No
Secondary	Symptom scores.		12 Weeks	No
Secondary	Global impression of change (patient and clinician).		12 Weeks	No
Secondary	Blood sample for pharmacokinetics.		12 Weeks	No
Secondary	Blood and urine sample for biomarkers and molecular profiling.		12 Weeks	No

External Links

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