NCT00156780

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Aug 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
Last Updated

October 23, 2006

Status Verified

July 1, 2006

First QC Date

September 8, 2005

Last Update Submit

October 19, 2006

Conditions

Congestive Heart FailureChronic Obstructive Pulmonary Disease

Keywords

ultrasound contrast agentpharmacokineticscongestive heart failurechronic obstructive pulmonary diseasesafety

Outcome Measures

Primary Outcomes (2)

  • 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

Interventions

AI-700DRUG

Sponsors & Collaborators

Study Sites (1)

Acusphere, Inc.

Watertown, Massachusetts, 02472, United States

Location

Related Links

MeSH Terms

Conditions

Heart FailurePulmonary Disease, Chronic Obstructive

Interventions

perfluorobutane

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
ECT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 8, 2005

First Posted

September 12, 2005

Study Start

August 1, 2004

Study Completion

July 1, 2005

Last Updated

October 23, 2006

Record last verified: 2006-07

Locations

US(1)