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

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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Congestive Heart Failure Cardiovascular Diseases Chronic Disease Chronic Obstructive Pulmonary Disease Disease Attributes Heart Diseases Heart Failure Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Study type

Interventional

Phase

Phase 1

Primary location

Acusphere, Inc.

Watertown, Massachusetts, 02472, United States

About this study

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.

Treatment and study plan

AI-700

Drug

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Acusphere

Industry

Registry information

Official study 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)

Important dates

Study start: 2004
Study completion: 2005
First posted: Sep 12, 2005
Registry last updated: Oct 23, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed