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A Phase III Study of Remimazolam in Patients Undergoing Bronchoscopy

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. Identifier: NCT02296892
Recruitment Status : Completed
First Posted : November 21, 2014
Results First Posted : March 12, 2019
Last Update Posted : March 18, 2020
Premier Research Group plc
Information provided by (Responsible Party):
Paion UK Ltd.

Brief Summary:
A prospective, double-blind, randomized, placebo and active controlled, multi-center, parallel group study comparing remimazolam to placebo, with an additional open label arm for midazolam, in patients undergoing a bronchoscopy.

Condition or disease Intervention/treatment Phase
Bronchoscopy Drug: Remimazolam Drug: Placebo Drug: Midazolam Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 446 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase III Study Evaluating the Efficacy and Safety of Remimazolam (CNS 7056) Compared to Placebo and Midazolam in Patients Undergoing Bronchoscopy
Actual Study Start Date : April 2015
Actual Primary Completion Date : March 2017
Actual Study Completion Date : March 13, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Remimazolam

Double-blind Remimazolam arm: 5 mg iv for sedation induction, and 2.5 mg iv top-ups for sedation maintenance.

Fentanyl pre-treatment: 25-50 μg (or less for elderly/disabled subjects), and 25 μg top-up doses

Drug: Remimazolam
For induction and maintenance of sedation
Other Name: CNS7056

Placebo Comparator: Placebo

Double-blind placebo arm as inactive control

Fentanyl pre-treatment: 25-50 μg (or less for elderly/disabled subjects), and 25 μg top-up doses

Drug: Placebo
Inactive control arm

Active Comparator: Midazolam

Open-label Midazolam arm: 1.75 mg* iv for sedation induction and 1.0 mg* iv for sedation maintenance. *1.0 mg for induction and 0.5 mg for maintenance in adults over 60, debilitated or chronically ill.

Fentanyl pre-treatment: 25-50 μg (or less for elderly/disabled subjects), and 25 μg top-up doses

Drug: Midazolam
For induction and maintenance of sedation
Other Name: Versed

Primary Outcome Measures :
  1. Number of Participants With a Successful Procedure [ Time Frame: From first dose of study drug to removal of bronchoscope (average time not known) ]
    Success of Procedure measured by completion of bronchoscopy, no requirement for an alternative rescue sedative medication and no requirement for more than 5 doses of study medication within any 15 minute period in the blinded arms (remimazolam/placebo) or no requirement for more than 3 doses within any 12 minute window in the open-label midazolam arm.

Secondary Outcome Measures :
  1. Time to Start of Procedure [ Time Frame: From first dose of study drug until insertion of the bronchoscope ]
    The time from the first dose of study drug until bronchoscope insertion on Day 1

  2. Time to Fully Alert [ Time Frame: From the last dose of study drug or rescue sedative AND from end of bronchoscopy until the patient has recovered to fully alert ]

    The time to fully alert defined as time to first of 3 consecutive Modified Observer's Assessment of Alertness and Sedation (MOAA/S) scores after the end of the bronchoscopy procedure (bronchoscope out).

    MOAA/S scores: 5 = Responds readily to name spoken in normal tone [alert], 4 =Lethargic response to name spoken in normal tone, 3 = Responds only after name is called loudly and/or repeatedly, 2 = Responds only after mild prodding or shaking, 1 = Responds only after painful trapezius squeeze, 0 = Does not respond to painful trapezius squeeze.

    MOAA/S scores were assessed by the investigators.

  3. Time to Ready for Discharge [ Time Frame: After the last dose of study drug AND after the end of the bronchoscopy, until discharge ]
    Time from the last dose of study drug or rescue sedative and from the end of bronchoscopy until discharge (defined as the ability to walk unassisted)

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.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Male and female patients, aged ≥18 years, scheduled to undergo a diagnostic or therapeutic flexible bronchoscopy in the bronchoscopy suite (therapeutic bronchoscopies could include eg, lavage, biopsies, brushings, and foreign body extraction).
  2. American Society of Anesthesiologists Physical Status Score (ASA PS) 1 through 3.
  3. Body mass index (BMI) ≤ 45.
  4. Peripheral blood oxygen saturation (measured by pulse oximetry: SpO2) ≥ 90% in ambient air or with no more than 2 L/min of oxygen support.
  5. For all female patients, negative result of urine pregnancy test. Additionally, for women of child bearing potential only, use of birth control during the study period (from the time of consent until all specified observations were completed).
  6. Patients voluntarily signed and dated an informed consent form that was approved by an IRB prior to the conduct of any study procedure, including screening procedures.
  7. Patient was willing and able to comply with study requirements and available for a follow up phone call on Day Day 4 (+3/ 1 days) after the bronchoscopy.

Exclusion Criteria:

  1. Patients with a known sensitivity to benzodiazepines, flumazenil, opioids, naloxone, or a medical condition such that these agents were contraindicated.
  2. Bronchoscopy outside the bronchoscopy unit (eg, intensive care unit).
  3. Patients on mechanical ventilation.
  4. Tracheal stenosis.
  5. Planned laser bronchoscopy, rigid scope bronchoscopy.
  6. Use of unstable doses of benzodiazepines and opioids for any indication, eg, insomnia, anxiety, or spasticity. An unstable dose means dose changes of more than 50% of the previous dose within 30 days prior to Day of procedure.
  7. Female patients with a positive pregnancy test at Screening or Baseline and lactating female patients.
  8. Patients with positive drugs of abuse screen (unless explained by concomitant medication) or a positive ethanol test at baseline.
  9. Patient with a history of drug or ethanol abuse within the past two years.
  10. Patients in receipt of any investigational drug or use of investigational device within 30 days or less than 7 t½ (whichever was longer) before the start of the study or scheduled to receive one during the study period.
  11. Participation in any previous clinical study with remimazolam.
  12. Patients with an inability to communicate well in English with the investigator or deemed unsuitable according to the investigator (in each case providing a reason).

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 identifier (NCT number): NCT02296892

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United States, Florida
Pab Clinical Research
Brandon, Florida, United States, 33511
Sun City Office
Sun City Center, Florida, United States, 33573
United States, Indiana
Laporte County Institute For Clinical Research
Michigan City, Indiana, United States, 46360
United States, Maryland
The Johns Hopkins Center for Interventional and Pulmonary Care
Baltimore, Maryland, United States, 21287
United States, Missouri
Washington University School of Medicine/Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63110
United States, North Carolina
Unc Division of Pulmonary and Critical Care
Chapel Hill, North Carolina, United States, 27599
Duke University
Durham, North Carolina, United States, 27710
Pinehurst Medical Clinic
Pinehurst, North Carolina, United States, 28374
Wake Forest Baptist Health
Winston-Salem, North Carolina, United States, 27157
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
S. Carolina Pharmaceutical Research
Spartanburg, South Carolina, United States, 29303
United States, Virginia
Pulmonary Associates of Richmond
Richmond, Virginia, United States, 23225
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
United States, Washington
Multicare Institute For Research & Innovation
Tacoma, Washington, United States, 98405
Sponsors and Collaborators
Paion UK Ltd.
Premier Research Group plc
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Principal Investigator: Gerard Silvestri, MD Medical University of South Carolina, US
  Study Documents (Full-Text)

Documents provided by Paion UK Ltd.:
Study Protocol  [PDF] March 3, 2016
Statistical Analysis Plan  [PDF] June 9, 2017

Publications of Results:
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Responsible Party: Paion UK Ltd. Identifier: NCT02296892    
Other Study ID Numbers: CNS7056-008
First Posted: November 21, 2014    Key Record Dates
Results First Posted: March 12, 2019
Last Update Posted: March 18, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Paion UK Ltd.:
Remimazolam, midazolam, bronchoscopy, procedural sedation
Additional relevant MeSH terms:
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Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action