A Study To Examine The Safety, Pharmacokinetics And Pharmacodynamics Of PF-03635659 In Patients With Chronic Obstructive Pulmonary Disease - Full Text View

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT01033487

Purpose

PF-03635659 is being developed for the treatment of chronic obstructive pulmonary disease. This is a study to examine the safety, pharmacokinetics and pharmacodynamics of PF-03635659 in patients with Chronic Obstructive Pulmonary Disease (COPD).

Condition	Intervention	Phase
Pulmonary Disease, Chronic Obstructive Lung Diseases Respiratory Tract Diseases Chronic Obstructive Airway Disease COPD	Drug: placebo Drug: active comparator Drug: PF-03635659	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Phase 2A, Double Blind, Placebo-Controlled, Single Dose, 5-Way Crossover Study Assessing The Pharmacodynamic, Pharmacokinetic And Safety Profiles Of Oral Inhaled PF-03635659 In Patients With Moderate Chronic Obstructive Pulmonary Disease.

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

FEV1 change from baseline [ Time Frame: 0-48hrs ] [ Designated as safety issue: No ]
PK parameters (Cmax, Tmax, AUClast, AUCinf, T½). [ Time Frame: 0-48hrs ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Peak FEV1 - change from baseline in maximum FEV1 [ Time Frame: 0-48hrs ] [ Designated as safety issue: No ]
Average AUEC change from baseline FEV1 [ Time Frame: 0-48hrs ] [ Designated as safety issue: No ]
Force Vital Capacity (FVC) [ Time Frame: 0-48hrs ] [ Designated as safety issue: No ]
Inspiratory Capacity (IC) [ Time Frame: 0-48hrs ] [ Designated as safety issue: No ]
Adverse Events, Blood pressure, pulse rate, ECG [ Time Frame: 0-48hrs ] [ Designated as safety issue: Yes ]

Enrollment:	22
Study Start Date:	January 2010
Study Completion Date:	June 2010
Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Placebo	Drug: placebo oral inhaled formulation, single dose
Active Comparator: Active comparator	Drug: active comparator oral inhaled formulation, single dose
Experimental: PF-03635659	Drug: PF-03635659 oral inhaled formulation, single dose, low dose Drug: PF-03635659 oral inhaled formulation, single dose, mid dose Drug: PF-03635659 oral inhaled formulation, single dose, high dose

Eligibility

Ages Eligible for Study:	40 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male or female (women of non-childbearing potential) subjects between the ages of 40 and 80 years, inclusive with a diagnosis of moderate COPD (GOLD, 2007 update) and who meet the following criteria for GOLD stage II disease
Body Mass Index (BMI) of less than 35.5 kg/m2; and a total body weight >40 kg (88 lbs).
Current smokers, or ex-smokers who have abstained from smoking for at least 6 months

Exclusion Criteria:

Subjects having more than 2 exacerbations requiring treatment with oral steroids or hospitalization for the treatment of COPD in the previous year.
History of lower respiratory tract infection or significant disease instability during the month preceding screening or during the period between screening and randomization.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01033487

Locations

Germany
Pfizer Investigational Site
Berlin, Germany, 10117

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier:	NCT01033487 History of Changes
Other Study ID Numbers:	B0431010
Study First Received:	December 15, 2009
Last Updated:	September 27, 2010
Health Authority:	Germany: BfArM

Keywords provided by Pfizer:

Safety
Pharmacokinetics
Pharmacodynamics
PF-03635659
COPD

Additional relevant MeSH terms:

Chronic Disease
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive

Respiratory Tract Diseases
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012