Safety, Toleration and Efficacy of Single Inhaled Doses of PF-00610355 in Chronic Obstructive Pulmonary (COPD) Patients. (A7881010)

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00783406
First received: October 30, 2008
Last updated: October 27, 2010
Last verified: October 2010
  Purpose

This study will look at the pharmacokinetics, safety, toleration and efficacy of PF-00610355 in the chronic obstructive pulmonary disease (COPD) population. The doses in this study are intended to explore the anticipated clinical dose range.


Condition Intervention Phase
Pulmonary Disease, Chronic Obstructive
Drug: PF-00610355
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2A, Double Blind (3rd Party Open), 4 Way Cross-Over, Placebo Controlled Study To Investigate The Pharmacokinetics, Safety, Toleration And Efficacy Of Single Inhaled Doses Of PF-00610355 In Moderate COPD Patients.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • To characterize the single dose pharmacokinetics of inhaled PF-00610355 in COPD patients. [ Time Frame: up to 8 days post dose ] [ Designated as safety issue: Yes ]
  • To evaluate the safety & toleration of single inhaled doses of PF-00610355 in COPD patients [ Time Frame: up to 24 hours post dose ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • To investigate the efficacy of a single inhaled dose of PF-00610355 in COPD patients. [ Time Frame: up to 24 hours post dose ] [ Designated as safety issue: Yes ]
  • To investigate the exposure/response relationship of PF-00610355. [ Time Frame: up to 8 days post dose ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: October 2008
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PF- 00610355 Drug: PF-00610355
dry powder inhaler, 1472 mcg, single dose
Experimental: PF-00610355 Drug: PF-00610355
dry powder inhaler, 736 mcg, single dose
Experimental: PF -00610355 Drug: PF-00610355
dry powder inhaler, 368 mcg, single dose
Placebo Comparator: Placebo Drug: Placebo
Placebo

  Eligibility

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

Inclusion Criteria:

  • Post-bronchodilator FEV1/ FVC ratio of <0.7.
  • Post bronchodilator FEV1 of 50-80% (inclusive) of predicted.
  • Body Mass Index (BMI) of less than 35 kg/m2; and a total body weight greater that 40 kg.
  • 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: NCT00783406

Locations
Germany
Pfizer Investigational Site
Berlin, Germany, 10117
Pfizer Investigational Site
Wiesbaden, Germany, 65187
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: NCT00783406     History of Changes
Other Study ID Numbers: A7881010
Study First Received: October 30, 2008
Last Updated: October 27, 2010
Health Authority: Germany: BfArM

Keywords provided by Pfizer:
COPD

Additional relevant MeSH terms:
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Lung Diseases, Obstructive

ClinicalTrials.gov processed this record on October 01, 2014