Back to resultsPhase 1 Safety and Pharmacokinetic Study of AI-700 in Patients With Diminished DLCO and COPD and/or CHF
Primary Purpose
Congestive Heart Failure, Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AI-700
Sponsored by
About this trial
This is an interventional educational/counseling/training trial for Congestive Heart Failure focused on measuring ultrasound contrast agent, pharmacokinetics, congestive heart failure, chronic obstructive pulmonary disease, safety
Eligibility Criteria
Sites / Locations
- Acusphere, Inc.
Outcomes
Primary Outcome Measures
To determine the safety of AI-700 in patients with diminished pulmonary diffusing capacity (DLCO) and moderate or severe COPD and/or CHF
To determine the pharmacokinetics of perfluorocarbon gas in blood following an intravenous injection of AI-700 in this patient population
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00156780
Brief Title
Phase 1 Safety and Pharmacokinetic Study of AI-700 in Patients With Diminished DLCO and COPD and/or CHF
Official Title
A Phase 1, Double Blind, Crossover, Placebo-Controlled, Dual-Injection, Safety and Pharmacokinetic Study of AI-700 in Patients With Diminished DLCO and Chronic Obstructive Pulmonary Disease (COPD) and/or Congestive Heart Failure (CHF)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2006
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Acusphere
4. Oversight
5. Study Description
Brief Summary
This study was conducted to evaluate the safety and pharmacokinetics of an echocardiographic contrast agent, AI-700, in patients with moderate to severe chronic obstructive pulmonary disease (COPD) and/or congestive heart failure (CHF).
Detailed Description
In ongoing clinical trials, AI-700 is currently being evaluated for its value to provide enhanced echocardiography to detect CAD. The patient population is comprised of those patients who have chest pain and are being evaluated for inducible ischemia. This population may include patients with compromised pulmonary function due to COPD or CHF. This study was to evaluate the safety of AI-700 in these patients.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure, Chronic Obstructive Pulmonary Disease
Keywords
ultrasound contrast agent, pharmacokinetics, congestive heart failure, chronic obstructive pulmonary disease, safety
7. Study Design
Primary Purpose
Educational/Counseling/Training
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
AI-700
Primary Outcome Measure Information:
Title
To determine the safety of AI-700 in patients with diminished pulmonary diffusing capacity (DLCO) and moderate or severe COPD and/or CHF
Title
To determine the pharmacokinetics of perfluorocarbon gas in blood following an intravenous injection of AI-700 in this patient population
10. Eligibility
Facility Information:
Facility Name
Acusphere, Inc.
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.acusphere.com
Description
Related Info
Learn more about this trial
Phase 1 Safety and Pharmacokinetic Study of AI-700 in Patients With Diminished DLCO and COPD and/or CHF
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