A Phase III Study of Remimazolam in Patients Undergoing Bronchoscopy

NCT02296892 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: CNS7056-008
• Study Type: interventional
• Target: 446
• Locations: 1 country
• Sites: 14

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.

Conditions

Bronchoscopy

Keywords

Remimazolam, midazolam, bronchoscopy, procedural sedation

Outcome Measures

Primary Outcomes (1)

• Number of Participants With a Successful Procedure

  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.

  From first dose of study drug to removal of bronchoscope (average time not known)

Secondary Outcomes (3)

• Time to Start of Procedure

  From first dose of study drug until insertion of the bronchoscope

• Time to Fully Alert

  From the last dose of study drug or rescue sedative AND from end of bronchoscopy until the patient has recovered to fully alert

• Time to Ready for Discharge

  After the last dose of study drug AND after the end of the bronchoscopy, until discharge

Study Arms (3)

Remimazolam

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Midazolam

ACTIVE COMPARATOR

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

Interventions

Remimazolam DRUG

For induction and maintenance of sedation

Also known as: CNS7056

Remimazolam

Placebo DRUG

Inactive control arm

Placebo

Midazolam DRUG

For induction and maintenance of sedation

Also known as: Versed

Midazolam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• American Society of Anesthesiologists Physical Status Score (ASA PS) 1 through 3.
• Body mass index (BMI) ≤ 45.
• Peripheral blood oxygen saturation (measured by pulse oximetry: SpO2) ≥ 90% in ambient air or with no more than 2 L/min of oxygen support.
• 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).
• 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.
• 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.

You may not qualify if:

• Patients with a known sensitivity to benzodiazepines, flumazenil, opioids, naloxone, or a medical condition such that these agents were contraindicated.
• Bronchoscopy outside the bronchoscopy unit (eg, intensive care unit).
• Patients on mechanical ventilation.
• Tracheal stenosis.
• Planned laser bronchoscopy, rigid scope bronchoscopy.
• 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.
• Female patients with a positive pregnancy test at Screening or Baseline and lactating female patients.
• Patients with positive drugs of abuse screen (unless explained by concomitant medication) or a positive ethanol test at baseline.
• Patient with a history of drug or ethanol abuse within the past two years.
• 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.
• Participation in any previous clinical study with remimazolam.
• 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).

Sponsors & Collaborators

• Paion UK Ltd.: lead
• Premier Research: collaborator

Study Sites (14)

Pab Clinical Research

Brandon, Florida, 33511, United States

Location

Sun City Office

Sun City Center, Florida, 33573, United States

Location

Laporte County Institute For Clinical Research

Michigan City, Indiana, 46360, United States

Location

The Johns Hopkins Center for Interventional and Pulmonary Care

Baltimore, Maryland, 21287, United States

Location

Washington University School of Medicine/Barnes-Jewish Hospital

St Louis, Missouri, 63110, United States

Location

Unc Division of Pulmonary and Critical Care

Chapel Hill, North Carolina, 27599, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Pinehurst Medical Clinic

Pinehurst, North Carolina, 28374, United States

Location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

S. Carolina Pharmaceutical Research

Spartanburg, South Carolina, 29303, United States

Location

Pulmonary Associates of Richmond

Richmond, Virginia, 23225, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Multicare Institute For Research & Innovation

Tacoma, Washington, 98405, United States

Location

Related Publications (1)

• Pastis NJ, Yarmus LB, Schippers F, Ostroff R, Chen A, Akulian J, Wahidi M, Shojaee S, Tanner NT, Callahan SP, Feldman G, Lorch DG Jr, Ndukwu I, Pritchett MA, Silvestri GA; PAION Investigators. Safety and Efficacy of Remimazolam Compared With Placebo and Midazolam for Moderate Sedation During Bronchoscopy. Chest. 2019 Jan;155(1):137-146. doi: 10.1016/j.chest.2018.09.015. Epub 2018 Oct 4.

  PMID: 30292760 RESULT

MeSH Terms

Interventions

remimazolam; Midazolam

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Trial Information
• Organization: PAION UK Ltd

reg_paion@paion.com

+49 2414453101

Study Officials

• Gerard Silvestri, MD

  Medical University of South Carolina, US

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2014
• First Posted: November 21, 2014
• Study Start: April 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 13, 2017
• Last Updated: March 18, 2020
• Results First Posted: March 12, 2019

Record last verified: 2020-03

Locations

US (14)