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

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)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00156780

Enrollment

Unknown

Registered

2005-09-12

Start date

2004-08-31

Completion date

2005-07-31

Last updated

2006-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease, Congestive Heart Failure

Keywords

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

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.

Interventions

DRUGAI-700

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

ECT

Masking

DOUBLE

Eligibility

Design outcomes

Primary

Measure	Time frame
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	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026