A Phase III Study of Remimazolam in Patients Undergoing Bronchoscopy

NCT ID: NCT02296892

Last Updated: 2020-03-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 446 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2017-03-13

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Remimazolam

Intervention Type: DRUG

For induction and maintenance of sedation

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Inactive control arm

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

Group Type: ACTIVE_COMPARATOR

Midazolam

Intervention Type: DRUG

For induction and maintenance of sedation

Interventions

Remimazolam

For induction and maintenance of sedation

Intervention Type: DRUG

Placebo

Inactive control arm

Intervention Type: DRUG

Midazolam

For induction and maintenance of sedation

Intervention Type: DRUG

Other Intervention Names

CNS7056; Versed

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Premier Research Group plc

UNKNOWN

Sponsor Role: collaborator

Paion UK Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gerard Silvestri, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina, US

Locations

Pab Clinical Research

Brandon, Florida, United States

Sun City Office

Sun City Center, Florida, United States

Laporte County Institute For Clinical Research

Michigan City, Indiana, United States

The Johns Hopkins Center for Interventional and Pulmonary Care

Baltimore, Maryland, United States

Washington University School of Medicine/Barnes-Jewish Hospital

St Louis, Missouri, United States

Unc Division of Pulmonary and Critical Care

Chapel Hill, North Carolina, United States

Duke University

Durham, North Carolina, United States

Pinehurst Medical Clinic

Pinehurst, North Carolina, United States

Wake Forest Baptist Health

Winston-Salem, North Carolina, United States

Medical University of South Carolina

Charleston, South Carolina, United States

S. Carolina Pharmaceutical Research

Spartanburg, South Carolina, United States

Pulmonary Associates of Richmond

Richmond, Virginia, United States

Virginia Commonwealth University

Richmond, Virginia, United States

Multicare Institute For Research & Innovation

Tacoma, Washington, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 30292760 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CNS7056-008

Identifier Type: -

Identifier Source: org_study_id