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NCT00808288 Clinical Trial

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

Pulmonary Disease, Chronic Obstructive Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00808288
Other study ID # A7881013
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date March 2010
Est. completion date December 2010

Study information
Verified date February 2019
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 405
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender All
Age group 40 Years to 80 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• PF-00610355
oral, inhaled, dry powder, 600ug, OD
• PF - 00610355
oral, inhaled, dry powder, 300ug, OD
• PF- 00610355
oral, inhaled, dry powder, 100ug, OD
• Placebo
oral, inhaled, dry powder, placebo, OD
• Salmeterol
salmeterol, 50ug, BID

Locations
Country Name City State
Argentina Pfizer Investigational Site Buenos Aires
Argentina Pfizer Investigational Site Buenos Aires
Argentina Pfizer Investigational Site Rosario Santa Fe
Bulgaria Pfizer Investigational Site Ruse
Bulgaria Pfizer Investigational Site Sofia
Bulgaria Pfizer Investigational Site Sofia
Bulgaria Pfizer Investigational Site Stara Zagora
Bulgaria Pfizer Investigational Site Troyan
Croatia Pfizer Investigational Site Zagreb
Czechia Pfizer Investigational Site Kutna Hora
Czechia Pfizer Investigational Site Liberec
Czechia Pfizer Investigational Site Praha 5
Czechia Pfizer Investigational Site Tabor
Germany Pfizer Investigational Site Berlin
Germany Pfizer Investigational Site Berlin
Germany Pfizer Investigational Site Frankfurt
Germany Pfizer Investigational Site Hamburg
Germany Pfizer Investigational Site Kassel
Germany Pfizer Investigational Site Luebeck
Germany Pfizer Investigational Site Schwerin
Germany Pfizer Investigational Site Wiesbaden
Hungary Pfizer Investigational Site Budapest
Hungary Pfizer Investigational Site Debrecen
Hungary Pfizer Investigational Site Szeged
Hungary Pfizer Investigational Site Szombathely
Hungary Pfizer Investigational Site Torokbalint
Poland Pfizer Investigational Site Lodz
Poland Pfizer Investigational Site Sopot
Poland Pfizer Investigational Site Warszawa
Poland Pfizer Investigational Site Wejherowo
Slovakia Pfizer Investigational Site Bojnice
Slovakia Pfizer Investigational Site Bratislava
Slovakia Pfizer Investigational Site Liptovsky Hradok
Slovakia Pfizer Investigational Site Nove Zamky
Slovakia Pfizer Investigational Site Poprad
Slovakia Pfizer Investigational Site Spisska Nova Ves
South Africa Pfizer Investigational Site Bellville Cape Town
South Africa Pfizer Investigational Site Bloemfontein Free State
South Africa Pfizer Investigational Site Bloemfontein
South Africa Pfizer Investigational Site Gatesville, Cape Town
South Africa Pfizer Investigational Site Tygerberg Cape Town
Spain Pfizer Investigational Site Pozuelo de Alarcon Madrid
Spain Pfizer Investigational Site Salt Girona
Turkey Pfizer Investigational Site Istanbul
Turkey Pfizer Investigational Site Izmir
United States Pfizer Investigational Site Austell Georgia
United States Pfizer Investigational Site Charleston South Carolina
United States Pfizer Investigational Site Charleston South Carolina
United States Pfizer Investigational Site Charlotte North Carolina
United States Pfizer Investigational Site Cincinnati Ohio
United States Pfizer Investigational Site Cincinnati Ohio
United States Pfizer Investigational Site Cincinnati Ohio
United States Pfizer Investigational Site Cincinnati Ohio
United States Pfizer Investigational Site Columbia South Carolina
United States Pfizer Investigational Site Daytona Beach Florida
United States Pfizer Investigational Site Fairhope Alabama
United States Pfizer Investigational Site Fridley Minnesota
United States Pfizer Investigational Site Houston Texas
United States Pfizer Investigational Site Lincoln Rhode Island
United States Pfizer Investigational Site Minneapolis Minnesota
United States Pfizer Investigational Site Morgantown West Virginia
United States Pfizer Investigational Site Oklahoma City Oklahoma
United States Pfizer Investigational Site Ormond Beach Florida
United States Pfizer Investigational Site Overland Park Kansas
United States Pfizer Investigational Site Overland Park Kansas
United States Pfizer Investigational Site Pawtucket Rhode Island
United States Pfizer Investigational Site Rochester New York
United States Pfizer Investigational Site Rochester Minnesota
United States Pfizer Investigational Site Saint Louis Missouri
United States Pfizer Investigational Site San Antonio Texas
United States Pfizer Investigational Site San Diego California
United States Pfizer Investigational Site Spring Valley California
United States Pfizer Investigational Site Tampa Florida
United States Pfizer Investigational Site Trinity Florida
United States Pfizer Investigational Site Wheat Ridge Colorado

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Bulgaria,  Croatia,  Czechia,  Germany,  Hungary,  Poland,  Slovakia,  South Africa,  Spain,  Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change from baseline in trough FEV1 6 week
Secondary Maximal and mean changes from baseline in heart rate, QTc and plasma potassium each visit
Secondary Change from baseline in peak FEV1 0-6 hours /6 weeks
Secondary Change from baseline in trough and peak FEV6, FVC and IC 6 weeks
Secondary Change from baseline in trough FEV1, FEV6, forced vital capacity (FVC) and inspiratory capacity (IC) 2 and 4 weeks
Secondary Change from baseline in Respiratory Questionnaire Self-Administered Standardised (CRQ-SAS) 2,4,6 weeks
Secondary Change from baseline of COPD symptoms and rescue bronchodilator use (per daily diary). weekly
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