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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01033487
First received: December 15, 2009
Last updated: September 27, 2010
Last verified: September 2010
  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 2

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 July 29, 2014