Clinical trial NCT00808288: A Study To Investigate The Safety, Toleration And Efficacy of PF00610355 In Chronic Obstructive Pulmonary Disease (COPD) Patients.
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Disease, Chronic Obstructive
Lung Diseases
Lung Diseases, Obstructive
Keywords: COPD Respiratory Long acting beta agonist
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-12-15
Enrollment: 405
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the effects and safety of PF-00610355 on patients with chronic obstructive lung disease (COPD)


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.

Primary outcomes:
measure: Change from baseline in trough FEV1
timeFrame: 6 week
Secondary outcomes:
measure: Maximal and mean changes from baseline in heart rate, QTc and plasma potassium
timeFrame: each visit
measure: Change from baseline in peak FEV1
timeFrame: 0-6 hours /6 weeks
measure: Change from baseline in trough and peak FEV6, FVC and IC
timeFrame: 6 weeks
measure: Change from baseline in trough FEV1, FEV6, forced vital capacity (FVC) and inspiratory capacity (IC)
timeFrame: 2 and 4 weeks
measure: Change from baseline in Respiratory Questionnaire Self-Administered Standardised (CRQ-SAS)
timeFrame: 2,4,6 weeks
measure: Change from baseline of COPD symptoms and rescue bronchodilator use (per daily diary).
timeFrame: weekly
Other outcomes:
Locations:
city: Fairhope
country: United States
facility: Pfizer Investigational Site
state: Alabama
city: San Diego
country: United States
facility: Pfizer Investigational Site
state: California
city: Spring Valley
country: United States
facility: Pfizer Investigational Site
state: California
city: Wheat Ridge
country: United States
facility: Pfizer Investigational Site
state: Colorado
city: Daytona Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Ormond Beach
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Tampa
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Trinity
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Austell
country: United States
facility: Pfizer Investigational Site
state: Georgia
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Overland Park
country: United States
facility: Pfizer Investigational Site
state: Kansas
city: Fridley
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Minneapolis
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: Minnesota
city: Saint Louis
country: United States
facility: Pfizer Investigational Site
state: Missouri
city: Rochester
country: United States
facility: Pfizer Investigational Site
state: New York
city: Charlotte
country: United States
facility: Pfizer Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Oklahoma City
country: United States
facility: Pfizer Investigational Site
state: Oklahoma
city: Lincoln
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: Pawtucket
country: United States
facility: Pfizer Investigational Site
state: Rhode Island
city: Charleston
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Charleston
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Columbia
country: United States
facility: Pfizer Investigational Site
state: South Carolina
city: Houston
country: United States
facility: Pfizer Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
city: Morgantown
country: United States
facility: Pfizer Investigational Site
state: West Virginia
city: Rosario
country: Argentina
facility: Pfizer Investigational Site
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Buenos Aires
country: Argentina
facility: Pfizer Investigational Site
city: Ruse
country: Bulgaria
facility: Pfizer Investigational Site
city: Sofia
country: Bulgaria
facility: Pfizer Investigational Site
city: Sofia
country: Bulgaria
facility: Pfizer Investigational Site
city: Stara Zagora
country: Bulgaria
facility: Pfizer Investigational Site
city: Troyan
country: Bulgaria
facility: Pfizer Investigational Site
city: Zagreb
country: Croatia
facility: Pfizer Investigational Site
city: Kutna Hora
country: Czechia
facility: Pfizer Investigational Site
city: Liberec
country: Czechia
facility: Pfizer Investigational Site
city: Praha 5
country: Czechia
facility: Pfizer Investigational Site
city: Tabor
country: Czechia
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Berlin
country: Germany
facility: Pfizer Investigational Site
city: Frankfurt
country: Germany
facility: Pfizer Investigational Site
city: Hamburg
country: Germany
facility: Pfizer Investigational Site
city: Kassel
country: Germany
facility: Pfizer Investigational Site
city: Luebeck
country: Germany
facility: Pfizer Investigational Site
city: Schwerin
country: Germany
facility: Pfizer Investigational Site
city: Wiesbaden
country: Germany
facility: Pfizer Investigational Site
city: Budapest
country: Hungary
facility: Pfizer Investigational Site
city: Debrecen
country: Hungary
facility: Pfizer Investigational Site
city: Szeged
country: Hungary
facility: Pfizer Investigational Site
city: Szombathely
country: Hungary
facility: Pfizer Investigational Site
city: Torokbalint
country: Hungary
facility: Pfizer Investigational Site
city: Lodz
country: Poland
facility: Pfizer Investigational Site
city: Sopot
country: Poland
facility: Pfizer Investigational Site
city: Warszawa
country: Poland
facility: Pfizer Investigational Site
city: Wejherowo
country: Poland
facility: Pfizer Investigational Site
city: Bojnice
country: Slovakia
facility: Pfizer Investigational Site
city: Bratislava
country: Slovakia
facility: Pfizer Investigational Site
city: Liptovsky Hradok
country: Slovakia
facility: Pfizer Investigational Site
city: Nove Zamky
country: Slovakia
facility: Pfizer Investigational Site
city: Poprad
country: Slovakia
facility: Pfizer Investigational Site
city: Spisska Nova Ves
country: Slovakia
facility: Pfizer Investigational Site
city: Bellville
country: South Africa
facility: Pfizer Investigational Site
state: Cape Town
city: Tygerberg
country: South Africa
facility: Pfizer Investigational Site
state: Cape Town
city: Bloemfontein
country: South Africa
facility: Pfizer Investigational Site
state: Free State
city: Bloemfontein
country: South Africa
facility: Pfizer Investigational Site
city: Gatesville, Cape Town
country: South Africa
facility: Pfizer Investigational Site
city: Salt
country: Spain
facility: Pfizer Investigational Site
state: Girona
city: Pozuelo de Alarcon
country: Spain
facility: Pfizer Investigational Site
state: Madrid
city: Istanbul
country: Turkey
facility: Pfizer Investigational Site
city: Izmir
country: Turkey
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: