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NCT00156780 Clinical Trial

Phase 1 Safety and Pharmacokinetic Study of AI-700 in Patients With Diminished DLCO and COPD and/or CHF

Chronic Obstructive Pulmonary Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00156780
Other study ID # AI-700-05
Secondary ID
Status Completed
Phase Phase 1
First received September 8, 2005
Last updated October 19, 2006
Start date August 2004
Est. completion date July 2005

Study information
Verified date July 2006
Source Acusphere
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

— Not specified —

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

Intervention

Drug:
• AI-700

Locations
Country Name City State
United States Acusphere, Inc. Watertown Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Acusphere

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary To determine the safety of AI-700 in patients with diminished pulmonary diffusing capacity (DLCO) and moderate or severe COPD and/or CHF
Primary To determine the pharmacokinetics of perfluorocarbon gas in blood following an intravenous injection of AI-700 in this patient population
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