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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2005-07-31

Brief Summary

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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

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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.

Conditions

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Congestive Heart Failure Chronic Obstructive Pulmonary Disease

Keywords

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ultrasound contrast agent pharmacokinetics congestive heart failure chronic obstructive pulmonary disease safety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

ECT

Blinding Strategy

DOUBLE

Interventions

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AI-700

Intervention Type DRUG

Eligibility Criteria

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Eligible Sex

Accepts Healthy Volunteers

No

Locations

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Acusphere, Inc.

Watertown, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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AI-700-05

Identifier Type: -

Identifier Source: org_study_id