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

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ClinicalTrials.gov Identifier: NCT00156780
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : October 23, 2006
Sponsor:
Information provided by:

Study Description
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).

Condition or disease Intervention/treatment Phase
Congestive Heart Failure Chronic Obstructive Pulmonary Disease Drug: AI-700 Phase 1

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Educational/Counseling/Training
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)
Study Start Date : August 2004
Estimated Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. To determine the safety of AI-700 in patients with diminished pulmonary diffusing capacity (DLCO) and moderate or severe COPD and/or CHF
  2. To determine the pharmacokinetics of perfluorocarbon gas in blood following an intravenous injection of AI-700 in this patient population

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Contacts and Locations

Information from the National Library of Medicine

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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00156780


Locations
United States, Massachusetts
Acusphere, Inc.
Watertown, Massachusetts, United States, 02472
Sponsors and Collaborators
Acusphere
More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00156780     History of Changes
Other Study ID Numbers: AI-700-05
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: October 23, 2006
Last Verified: July 2006

Keywords provided by Acusphere:
ultrasound contrast agent
pharmacokinetics
congestive heart failure
chronic obstructive pulmonary disease
safety

Additional relevant MeSH terms:
Heart Failure
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Heart Diseases
Cardiovascular Diseases
Respiratory Tract Diseases