Safety, Toleration and Efficacy of Single Inhaled Doses of PF-00610355 in Chronic Obstructive Pulmonary (COPD) Patients. (A7881010)
Primary Purpose
Pulmonary Disease, Chronic Obstructive
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
PF-00610355
PF-00610355
PF-00610355
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive focused on measuring COPD
Eligibility 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.
Sites / Locations
- Pfizer Investigational Site
- Pfizer Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
PF- 00610355
PF-00610355
PF -00610355
Placebo
Arm Description
Outcomes
Primary Outcome Measures
To characterize the single dose pharmacokinetics of inhaled PF-00610355 in COPD patients.
To evaluate the safety & toleration of single inhaled doses of PF-00610355 in COPD patients
Secondary Outcome Measures
To investigate the efficacy of a single inhaled dose of PF-00610355 in COPD patients.
To investigate the exposure/response relationship of PF-00610355.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00783406
Brief Title
Safety, Toleration and Efficacy of Single Inhaled Doses of PF-00610355 in Chronic Obstructive Pulmonary (COPD) Patients.
Acronym
A7881010
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.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
March 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Pfizer
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
COPD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
PF- 00610355
Arm Type
Experimental
Arm Title
PF-00610355
Arm Type
Experimental
Arm Title
PF -00610355
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
PF-00610355
Intervention Description
dry powder inhaler, 1472 mcg, single dose
Intervention Type
Drug
Intervention Name(s)
PF-00610355
Intervention Description
dry powder inhaler, 736 mcg, single dose
Intervention Type
Drug
Intervention Name(s)
PF-00610355
Intervention Description
dry powder inhaler, 368 mcg, single dose
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
To characterize the single dose pharmacokinetics of inhaled PF-00610355 in COPD patients.
Time Frame
up to 8 days post dose
Title
To evaluate the safety & toleration of single inhaled doses of PF-00610355 in COPD patients
Time Frame
up to 24 hours post dose
Secondary Outcome Measure Information:
Title
To investigate the efficacy of a single inhaled dose of PF-00610355 in COPD patients.
Time Frame
up to 24 hours post dose
Title
To investigate the exposure/response relationship of PF-00610355.
Time Frame
up to 8 days post dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Pfizer Investigational Site
City
Wiesbaden
ZIP/Postal Code
65187
Country
Germany
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A7881010&StudyName=Safety%2C%20Toleration%20and%20Efficacy%20of%20Single%20Inhaled%20Doses%20of%20PF-00610355%20in%20Chronic%20Obstructive%20Pulmonary%20%28COPD%29%20Patients.
Description
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Safety, Toleration and Efficacy of Single Inhaled Doses of PF-00610355 in Chronic Obstructive Pulmonary (COPD) Patients.
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