A Phase III Study of Remimazolam in Patients Undergoing Bronchoscopy

Bronchoscopy Clinical Trial

Official title:

A Phase III Study Evaluating the Efficacy and Safety of Remimazolam (CNS 7056) Compared to Placebo and Midazolam in Patients Undergoing Bronchoscopy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02296892
• Other study ID #: CNS7056-008
• Status: Completed
• Phase: Phase 3
• Start date: April 2015
• Est. completion date: March 13, 2017

Study information

• Verified date: March 2020
• Source: Paion UK Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 446
• Est. completion date: March 13, 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Bronchoscopy

Intervention

Drug:
• Remimazolam
For induction and maintenance of sedation
• Placebo
Inactive control arm
• Midazolam
For induction and maintenance of sedation

Locations

Country	Name	City	State
United States	The Johns Hopkins Center for Interventional and Pulmonary Care	Baltimore	Maryland
United States	Pab Clinical Research	Brandon	Florida
United States	Unc Division of Pulmonary and Critical Care	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Duke University	Durham	North Carolina
United States	Laporte County Institute For Clinical Research	Michigan City	Indiana
United States	Pinehurst Medical Clinic	Pinehurst	North Carolina
United States	Pulmonary Associates of Richmond	Richmond	Virginia
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Washington University School of Medicine/Barnes-Jewish Hospital	Saint Louis	Missouri
United States	S. Carolina Pharmaceutical Research	Spartanburg	South Carolina
United States	Sun City Office	Sun City Center	Florida
United States	Multicare Institute For Research & Innovation	Tacoma	Washington
United States	Wake Forest Baptist Health	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Paion UK Ltd.	Premier Research Group plc

Country where clinical trial is conducted

United States, 

References & 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 M — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to Start of Procedure	The time from the first dose of study drug until bronchoscope insertion on Day 1	From first dose of study drug until insertion of the bronchoscope
Secondary	Time 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.	From the last dose of study drug or rescue sedative AND from end of bronchoscopy until the patient has recovered to fully alert
Secondary	Time to Ready for 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)	After the last dose of study drug AND after the end of the bronchoscopy, until discharge