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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

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PH-797804
Placebo
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pfizer Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PH-797804

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

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.
Dyspnea index scores.
Rescue bronchodilator usage.
Symptom scores.
Global impression of change (patient and clinician).
Blood sample for pharmacokinetics.
Blood and urine sample for biomarkers and molecular profiling.

Full Information

First Posted
March 21, 2011
Last Updated
July 8, 2013
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01321463
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
377 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PH-797804
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
PH-797804
Intervention Description
6 mg oral tablet once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo oral tablet once daily for 12 weeks
Primary Outcome Measure Information:
Title
Spirometry measures during 12 weeks of treatment and up to 2 weeks post treatment.
Time Frame
12 Weeks
Secondary Outcome Measure Information:
Title
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
Title
Dyspnea index scores.
Time Frame
12 Weeks
Title
Rescue bronchodilator usage.
Time Frame
12 Weeks
Title
Symptom scores.
Time Frame
12 Weeks
Title
Global impression of change (patient and clinician).
Time Frame
12 Weeks
Title
Blood sample for pharmacokinetics.
Time Frame
12 Weeks
Title
Blood and urine sample for biomarkers and molecular profiling.
Time Frame
12 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Pfizer Investigational Site
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Pfizer Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Pfizer Investigational Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Pfizer Investigational Site
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
Pfizer Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Pfizer Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Pfizer Investigational Site
City
Trinity
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
Facility Name
Pfizer Investigational Site
City
Conyers
State/Province
Georgia
ZIP/Postal Code
30094
Country
United States
Facility Name
Pfizer Investigational Site
City
Duluth
State/Province
Georgia
ZIP/Postal Code
30096
Country
United States
Facility Name
Pfizer Investigational Site
City
Norcross
State/Province
Georgia
ZIP/Postal Code
30071
Country
United States
Facility Name
Pfizer Investigational Site
City
Livonia
State/Province
Michigan
ZIP/Postal Code
48152
Country
United States
Facility Name
Pfizer Investigational Site
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Pfizer Investigational Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Pfizer Investigational Site
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Pfizer Investigational Site
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Pfizer Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45231
Country
United States
Facility Name
Pfizer Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45245
Country
United States
Facility Name
Pfizer Investigational Site
City
Lincoln
State/Province
Rhode Island
ZIP/Postal Code
02865
Country
United States
Facility Name
Pfizer Investigational Site
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Pfizer Investigational Site
City
Mckinney
State/Province
Texas
ZIP/Postal Code
75069
Country
United States
Facility Name
Pfizer Investigational Site
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
C1440BRR
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Buenos Aires
ZIP/Postal Code
1426
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Daw Park
State/Province
South Australia
ZIP/Postal Code
5041
Country
Australia
Facility Name
Pfizer Investigational Site
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Pfizer Investigational Site
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
Pfizer Investigational Site
City
Sevlievo
ZIP/Postal Code
5400
Country
Bulgaria
Facility Name
Pfizer Investigational Site
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
Pfizer Investigational Site
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Pfizer Investigational Site
City
Stara Zagora
ZIP/Postal Code
6003
Country
Bulgaria
Facility Name
Pfizer Investigational Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T1Y 6J4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Niagara Falls
State/Province
Ontario
ZIP/Postal Code
L2G 1J4
Country
Canada
Facility Name
Pfizer Investigational Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4G2
Country
Canada
Facility Name
Pfizer Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6H 3M2
Country
Canada
Facility Name
Pfizer Investigational Site
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G8T 7A1
Country
Canada
Facility Name
Pfizer Investigational Site
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Pfizer Investigational Site
City
Quillota
State/Province
V Region
ZIP/Postal Code
2260494
Country
Chile
Facility Name
Pfizer Investigational Site
City
Valparaiso
State/Province
V Region
ZIP/Postal Code
2352499
Country
Chile
Facility Name
Pfizer Investigational Site
City
Kutna Hora
ZIP/Postal Code
284 01
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Liberec
ZIP/Postal Code
460 01
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Pardubice
ZIP/Postal Code
530 09
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Praha 10- Malesice
ZIP/Postal Code
108 00
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Tabor
ZIP/Postal Code
39001
Country
Czech Republic
Facility Name
Pfizer Investigational Site
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Gyula
ZIP/Postal Code
5703
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Szeged
ZIP/Postal Code
6722
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Ahmedabad
State/Province
Gujarat
ZIP/Postal Code
380 052
Country
India
Facility Name
Pfizer Investigational Site
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440 012
Country
India
Facility Name
Pfizer Investigational Site
City
Coimbatore
State/Province
Tamil Nadu
ZIP/Postal Code
641 004
Country
India
Facility Name
Pfizer Investigational Site
City
Newtown
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Pfizer Investigational Site
City
Tauranga
ZIP/Postal Code
3110
Country
New Zealand
Facility Name
Pfizer Investigational Site
City
Leczna
ZIP/Postal Code
21-010
Country
Poland
Facility Name
Pfizer Investigational Site
City
Warszawa
ZIP/Postal Code
04-141
Country
Poland
Facility Name
Pfizer Investigational Site
City
Zawadzkie
ZIP/Postal Code
47-120
Country
Poland
Facility Name
Pfizer Investigational Site
City
Bojnice
ZIP/Postal Code
972 01
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Bratislava
ZIP/Postal Code
826 06
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Kosice
ZIP/Postal Code
040 01
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Liptovsky Hradok
ZIP/Postal Code
033 01
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Povazska Bystrica
ZIP/Postal Code
017 26
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Spisska Nova Ves
ZIP/Postal Code
052 01
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Bellville
State/Province
Cape Town
ZIP/Postal Code
7530
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Tygerberg Campus
State/Province
Cape Town
ZIP/Postal Code
7505
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Amanzimtoti
State/Province
Durban
ZIP/Postal Code
4126
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Durban
State/Province
Kwa-Zulu Natal
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Goteborg
ZIP/Postal Code
400 14
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Goteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Lund
ZIP/Postal Code
22185
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Stockholm
ZIP/Postal Code
171 76
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Cottingham
State/Province
Hull
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Facility Name
Pfizer Investigational Site
City
Glasgow
ZIP/Postal Code
G12 OYN
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A6631029&StudyName=Study%20To%20Evaluate%20The%20Efficacy%20And%20Safety%20Of%20PH-797804%20For%2012%20Weeks%20In%20Adults%20With%20Moderate%20To%20Severe%20Chronic%20Obstructive%20Pulmonary%20
Description
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Learn more about this trial

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

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