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A Study To Investigate The Safety, Toleration And Efficacy of PF00610355 In Chronic Obstructive Pulmonary Disease (COPD) Patients. (A7881013)

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
PF-00610355
PF - 00610355
PF- 00610355
Placebo
Salmeterol
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring COPD Respiratory Long acting beta agonist

Eligibility Criteria

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

Inclusion Criteria:

  • Post-bronchodilator FEV1/FVC ratio <0.7 and a post-bronchodilator FEV1 of 50-80%.
  • Diagnosis of moderate COPD for a minimum of 6 months.
  • Stable disease for at least 1 month prior to screening

Exclusion Criteria:

  • More than 2 exacerbations of COPD requiring treatment with oral steroids in the preceding year or hospitalisation for the treatment of COPD within 3 months of screening or more than twice during the preceding year.
  • History of a lower respiratory tract infection or significant disease instability during the month preceding screening or during the time between screening and randomisation.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Active Comparator

Arm Label

PF-00610355

PF- 00610355

PF - 00610355

Placebo

Salmeterol

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in trough FEV1

Secondary Outcome Measures

Maximal and mean changes from baseline in heart rate, QTc and plasma potassium
Change from baseline in peak FEV1
Change from baseline in trough and peak FEV6, FVC and IC
Change from baseline in trough FEV1, FEV6, forced vital capacity (FVC) and inspiratory capacity (IC)
Change from baseline in Respiratory Questionnaire Self-Administered Standardised (CRQ-SAS)
Change from baseline of COPD symptoms and rescue bronchodilator use (per daily diary).

Full Information

First Posted
December 12, 2008
Last Updated
February 1, 2019
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00808288
Brief Title
A Study To Investigate The Safety, Toleration And Efficacy of PF00610355 In Chronic Obstructive Pulmonary Disease (COPD) Patients.
Acronym
A7881013
Official Title
A Phase 2b, Parallel Group, Placebo And Active Comparator Controlled Study To Investigate The Safety, Toleration And Efficacy Of 6-Week Once Daily Administration Of Inhaled PF-00610355 Dry Powder In Patients With Moderate Chronic Obstructive Pulmonary Disease.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (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
To assess the effects and safety of PF-00610355 on patients with chronic obstructive lung disease (COPD)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive, Lung Diseases, Lung Diseases, Obstructive
Keywords
COPD Respiratory Long acting beta agonist

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
405 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PF-00610355
Arm Type
Experimental
Arm Title
PF- 00610355
Arm Type
Experimental
Arm Title
PF - 00610355
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Salmeterol
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
PF-00610355
Intervention Description
oral, inhaled, dry powder, 600ug, OD
Intervention Type
Drug
Intervention Name(s)
PF - 00610355
Intervention Description
oral, inhaled, dry powder, 300ug, OD
Intervention Type
Drug
Intervention Name(s)
PF- 00610355
Intervention Description
oral, inhaled, dry powder, 100ug, OD
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral, inhaled, dry powder, placebo, OD
Intervention Type
Drug
Intervention Name(s)
Salmeterol
Intervention Description
salmeterol, 50ug, BID
Primary Outcome Measure Information:
Title
Change from baseline in trough FEV1
Time Frame
6 week
Secondary Outcome Measure Information:
Title
Maximal and mean changes from baseline in heart rate, QTc and plasma potassium
Time Frame
each visit
Title
Change from baseline in peak FEV1
Time Frame
0-6 hours /6 weeks
Title
Change from baseline in trough and peak FEV6, FVC and IC
Time Frame
6 weeks
Title
Change from baseline in trough FEV1, FEV6, forced vital capacity (FVC) and inspiratory capacity (IC)
Time Frame
2 and 4 weeks
Title
Change from baseline in Respiratory Questionnaire Self-Administered Standardised (CRQ-SAS)
Time Frame
2,4,6 weeks
Title
Change from baseline of COPD symptoms and rescue bronchodilator use (per daily diary).
Time Frame
weekly

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: Post-bronchodilator FEV1/FVC ratio <0.7 and a post-bronchodilator FEV1 of 50-80%. Diagnosis of moderate COPD for a minimum of 6 months. Stable disease for at least 1 month prior to screening Exclusion Criteria: More than 2 exacerbations of COPD requiring treatment with oral steroids in the preceding year or hospitalisation for the treatment of COPD within 3 months of screening or more than twice during the preceding year. History of a lower respiratory tract infection or significant disease instability during the month preceding screening or during the time between screening and randomisation.
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
Fairhope
State/Province
Alabama
ZIP/Postal Code
36532
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
Spring Valley
State/Province
California
ZIP/Postal Code
91978
Country
United States
Facility Name
Pfizer Investigational Site
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Pfizer Investigational Site
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32114
Country
United States
Facility Name
Pfizer Investigational Site
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
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
Austell
State/Province
Georgia
ZIP/Postal Code
30106
Country
United States
Facility Name
Pfizer Investigational Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Pfizer Investigational Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
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
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Pfizer Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14618
Country
United States
Facility Name
Pfizer Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Pfizer Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
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
45242
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
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
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
Pawtucket
State/Province
Rhode Island
ZIP/Postal Code
02860
Country
United States
Facility Name
Pfizer Investigational Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Pfizer Investigational Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Pfizer Investigational Site
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
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
San Antonio
State/Province
Texas
ZIP/Postal Code
78212
Country
United States
Facility Name
Pfizer Investigational Site
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States
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
Buenos Aires
ZIP/Postal Code
C1405BCH
Country
Argentina
Facility Name
Pfizer Investigational Site
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Facility Name
Pfizer Investigational Site
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Pfizer Investigational Site
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Facility Name
Pfizer Investigational Site
City
Stara Zagora
ZIP/Postal Code
6003
Country
Bulgaria
Facility Name
Pfizer Investigational Site
City
Troyan
ZIP/Postal Code
5600
Country
Bulgaria
Facility Name
Pfizer Investigational Site
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Pfizer Investigational Site
City
Kutna Hora
ZIP/Postal Code
283 01
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Liberec
ZIP/Postal Code
460 01
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Praha 5
ZIP/Postal Code
153 00
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Tabor
ZIP/Postal Code
39001
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Berlin
ZIP/Postal Code
12687
Country
Germany
Facility Name
Pfizer Investigational Site
City
Berlin
ZIP/Postal Code
14057
Country
Germany
Facility Name
Pfizer Investigational Site
City
Frankfurt
ZIP/Postal Code
60596
Country
Germany
Facility Name
Pfizer Investigational Site
City
Hamburg
ZIP/Postal Code
20354
Country
Germany
Facility Name
Pfizer Investigational Site
City
Kassel
ZIP/Postal Code
34121
Country
Germany
Facility Name
Pfizer Investigational Site
City
Luebeck
ZIP/Postal Code
23552
Country
Germany
Facility Name
Pfizer Investigational Site
City
Schwerin
ZIP/Postal Code
19055
Country
Germany
Facility Name
Pfizer Investigational Site
City
Wiesbaden
ZIP/Postal Code
65187
Country
Germany
Facility Name
Pfizer Investigational Site
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Debrecen
ZIP/Postal Code
4012
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Szeged
ZIP/Postal Code
6772
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Szombathely
ZIP/Postal Code
9700
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Torokbalint
ZIP/Postal Code
2045
Country
Hungary
Facility Name
Pfizer Investigational Site
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Pfizer Investigational Site
City
Sopot
ZIP/Postal Code
81-741
Country
Poland
Facility Name
Pfizer Investigational Site
City
Warszawa
ZIP/Postal Code
04-141
Country
Poland
Facility Name
Pfizer Investigational Site
City
Wejherowo
ZIP/Postal Code
84-200
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
Liptovsky Hradok
ZIP/Postal Code
033 01
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Nove Zamky
ZIP/Postal Code
940 01
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Poprad
ZIP/Postal Code
058 01
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
State/Province
Cape Town
ZIP/Postal Code
7505
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Bloemfontein
State/Province
Free State
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Bloemfontein
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Gatesville, Cape Town
ZIP/Postal Code
7764
Country
South Africa
Facility Name
Pfizer Investigational Site
City
Salt
State/Province
Girona
ZIP/Postal Code
17190
Country
Spain
Facility Name
Pfizer Investigational Site
City
Pozuelo de Alarcon
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Facility Name
Pfizer Investigational Site
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Pfizer Investigational Site
City
Izmir
ZIP/Postal Code
35100
Country
Turkey

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A7881013&StudyName=A%20Study%20To%20Investigate%20The%20Safety%2C%20Toleration%20And%20Efficacy%20of%20PF00610355%20In%20Chronic%20Obstructive%20Pulmonary%20Disease%20%28COPD%29%20Patients.
Description
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Learn more about this trial

A Study To Investigate The Safety, Toleration And Efficacy of PF00610355 In Chronic Obstructive Pulmonary Disease (COPD) Patients.

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