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:
Information provided by:
Acusphere
ClinicalTrials.gov Identifier:
NCT00156780
First received: September 8, 2005
Last updated: October 19, 2006
Last verified: July 2006
  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
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
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

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00156780

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

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00156780     History of Changes
Other Study ID Numbers: AI-700-05
Study First Received: September 8, 2005
Last Updated: October 19, 2006
Health Authority: United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on September 16, 2014