Safety, Toleration and Efficacy of Single Inhaled Doses of PF-00610355 in Chronic Obstructive Pulmonary (COPD) Patients.
A7881010
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.
1 other identifier
interventional
20
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Oct 2008
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 30, 2008
CompletedFirst Posted
Study publicly available on registry
October 31, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedNovember 1, 2010
October 1, 2010
5 months
October 30, 2008
October 27, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
To characterize the single dose pharmacokinetics of inhaled PF-00610355 in COPD patients.
up to 8 days post dose
To evaluate the safety & toleration of single inhaled doses of PF-00610355 in COPD patients
up to 24 hours post dose
Secondary Outcomes (2)
To investigate the efficacy of a single inhaled dose of PF-00610355 in COPD patients.
up to 24 hours post dose
To investigate the exposure/response relationship of PF-00610355.
up to 8 days post dose
Study Arms (4)
PF- 00610355
EXPERIMENTALPF-00610355
EXPERIMENTALPF -00610355
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (2)
Pfizer Investigational Site
Berlin, 10117, Germany
Pfizer Investigational Site
Wiesbaden, 65187, Germany
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 30, 2008
First Posted
October 31, 2008
Study Start
October 1, 2008
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
November 1, 2010
Record last verified: 2010-10