An Effectiveness and Safety Study of AQUAVAN® Injection (Fospropofol Disodium) for Sedation During Flexible Bronchoscopy

Condition(s) targeted: Bronchoscopy; Anesthesia

Intervention: AQUAVAN® (fospropofol disodium) Injection (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: MGI Pharma

Official(s) and/or principal investigator(s):
James Jones, MD, PharmD, Study Director, Affiliation: MGI Pharma

Very often patients receive medication before a diagnostic, therapeutic, or surgical procedure to help them relax, keep them calm, and to relieve them from pain. This is called procedural sedation. During procedural (mild-to-moderate) sedation, a patient is first given a pain-relief medication (analgesic) and then a medication to help him/her relax and keep him/her calm (sedative). Propofol is the drug commonly used for sedation because it releases immediately into the blood stream and causes fast sedation. AQUAVAN (fospropofol disodium) is made as a slow release version of propofol with a longer duration of effect.

Official title: A Phase 3, Randomized, Double-Blind, Dose-Controlled Study To Assess The Efficacy And Safety Of AQUAVAN® (Fospropofol Disodium) Injection For Minimal-To-Moderate Sedation In Patients Undergoing Flexible Bronchoscopy

Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

Sedation Success rate is defined as: Having 3 consecutive Modified Observer's Assessment of Alertness/Sedation (OAA/S) scale scores of ≤4 after administration of sedative medication

Completing the procedure

Without requiring the use of alternative sedative medication

Without requiring manual or mechanical ventilation

Secondary outcome:

Treatment Success rate - Treatment Success is defined as a patient (i) completing the procedure (ii) without requiring alternative sedative medications AND (iii) without requiring manual or mechanical ventilation

Proportion of patients willing to be treated again with the same study sedative medication

Proportion of patients who do not recall being awake during the procedure

Detailed description: This is a phase 3, randomized, double-blind, dose-controlled study designed to evaluate the efficacy and safety of AQUAVAN 6. 5 mg/kg compared to a minimally effective dose of AQUAVAN 2. 0 mg/kg, both following pretreatment with an analgesic, fentanyl in patients who are undergoing flexible bronchoscopy. Following completion of preprocedure assessments, patients will be randomly assigned to 1 of 2 treatment groups at a 2: 3 (AQUAVAN initial dose 1 [2. 0 mg/kg]:AQUAVAN initial dose 2 [6. 5 mg/kg] allocation ratio on the day of the scheduled procedure. Randomization will be stratified by site. A person skilled in airway management (such as a respiratory therapist, a study nurse, or a clinician) and authorized by the facility in which the colonoscopy is performed must be immediately available during the conduct of the study. All patients will be placed on supplemental oxygen via nasal cannula (4 L/min), and an ECG monitor, pulse oximeter, and blood pressure monitor will be attached prior to administration of study medication. All patients will receive analgesic pretreatment (fentanyl citrate injection for pain; lidocaine for topical anesthetic followed by the administration of study medication. Assessments will be made to evaluate the patients for levels of sedation, clinical benefit of sedation, and adverse events. Blood samples will be collected for PK analysis.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: Patient must be able to understand, either orally or in writing, and be able to consent and complete the required assessments and procedures Patient provides signed/dated Informed Consent and Health Insurance Portability and Accountability Act of 1996 (HIPAA) authorization after receiving a full explanation of the extent and nature of the study. Patient must be at least 18 years of age at the time of screening. If female, patient must be surgically sterile, postmenopausal, or not pregnant or lactating and must have been using an acceptable method of birth control for at least 1 month prior to dosing, with a negative urine pregnancy test result at screening and predose. Patient meets American Society of Anesthesiologists (ASA) Physical Classification System status of P1 to P4. Exclusion Criteria: Patient has a history of allergic reaction or hypersensitivity to any anesthetic agent or opioid. Patient does not meet nils per os (NPO) status per ASA guidelines or institution's guideline. Patient has a Mallampati Classification Score of 4; OR a Mallampati Classification Score of 3 AND a thyromental distance ≤4 cm, or for any other reason has a difficult airway, in the opinion of the Investigator. Patient has an abnormal, clinically significant 3-lead ECG finding at predosing period Day 0. Patient has participated in an investigational drug study within 1 month prior to study start. Patient is unwilling to adhere to pre- and postprocedural instructions. Patient for whom the use of fentanyl citrate injection (fentanyl) is contraindicated.

Pulmonary Associates of Mobile, PC, Mobile, Alabama 36608, United States

Precision Trials, Phoenix, Arizona 85032, United States

USC Health Science Campus (USC University Hospital), Los Angeles, California 90033, United States

Saddleback Memorial Medical Center, Laguna Hills, California 92653, United States

Pensacola Research Consultants, Inc., Pensacola, Florida 32503, United States

Acute Care Consultants Inc., Augusta, Georgia 30909, United States

Graves-Gilbert Clinic, Bowling Green, Kentucky 42101, United States

Central Maine Pulmonary Associates, Auburn, Maine 04210, United States

Berkshire Medical Center, Pittsfield, Maryland 01201, United States

Hurley Medical Center, Flint, Michigan 48503, United States

International Heart Institue of MT Foundation, Missoula, Montana 59802, United States

Keith Popovich, MD, PLLC, Butte, Montana 59701, United States

University of Nebraska Medical Center, Omaha, Nebraska 68198, United States

United Health Scrvices Hosptial, INC, Johnson City, New York 13790, United States

Brody School of Medicine, Greenville, North Carolina 27834, United States

ALL-TRIALS Clinical Research, LLC, Winston-Salem, North Carolina 27103, United States

University of Cincinnati, The University Hospital, Cincinnati, Ohio 45267, United States

Lowcountry Lung & Critical Care, PA, Charleston, South Carolina 29406, United States

Medical University of South Carolina, Charleston, South Carolina 29425, United States

Greenville Hospital System, Greenville, South Carolina 29605, United States

South Carolina Pharmaceutical Research, Spartanburg, South Carolina 29303, United States

Spartanburg Medical Research, Spartanburg, South Carolina 29303, United States

The University of Texas Medical Branch Division of APICS, Galveston, Texas 77555, United States

Johnston Memorial Hospital Pulmonary Research, Abingdon, Virginia 24210, United States

Pulmonary Associates of Fredericksburg, Inc., Fredericksburg, Virginia 22401, United States

Starting date: April 2006
Ending date: May 2007
Last updated: November 5, 2007