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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00156780
First Posted: September 12, 2005
Last Update Posted: October 23, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Acusphere
  Purpose
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 Intervention Phase
Congestive Heart Failure Chronic Obstructive Pulmonary Disease Drug: AI-700 Phase 1

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Acusphere:

Primary Outcome Measures:
  • 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

Study Start Date: August 2004
Estimated Study Completion Date: July 2005
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

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 Submitted: September 8, 2005
First Posted: September 12, 2005
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