Clinical trial NCT02296892: A Phase III Study of Remimazolam in Patients Undergoing Bronchoscopy
Official title: A Phase III Study Evaluating the Efficacy and Safety of Remimazolam (CNS 7056) Compared to Placebo and Midazolam in Patients Undergoing Bronchoscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bronchoscopy
Keywords: Remimazolam, midazolam, bronchoscopy, procedural sedation
Lead sponsor: Paion UK Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Premier Research Group plc
First posted: 2014-11-21
Enrollment: 446
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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).

Primary outcomes:
measure: Number of Participants With a Successful Procedure
timeFrame: From first dose of study drug to removal of bronchoscope (average time not known)
Secondary outcomes:
measure: Time to Start of Procedure
timeFrame: From first dose of study drug until insertion of the bronchoscope
measure: Time to Fully Alert
timeFrame: From the last dose of study drug or rescue sedative AND from end of bronchoscopy until the patient has recovered to fully alert
measure: Time to Ready for Discharge
timeFrame: After the last dose of study drug AND after the end of the bronchoscopy, until discharge
Other outcomes:
Locations:
city: Brandon
country: United States
facility: Pab Clinical Research
state: Florida
city: Sun City Center
country: United States
facility: Sun City Office
state: Florida
city: Michigan City
country: United States
facility: Laporte County Institute For Clinical Research
state: Indiana
city: Baltimore
country: United States
facility: The Johns Hopkins Center for Interventional and Pulmonary Care
state: Maryland
city: Saint Louis
country: United States
facility: Washington University School of Medicine/Barnes-Jewish Hospital
state: Missouri
city: Chapel Hill
country: United States
facility: Unc Division of Pulmonary and Critical Care
state: North Carolina
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Pinehurst
country: United States
facility: Pinehurst Medical Clinic
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health
state: North Carolina
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Spartanburg
country: United States
facility: S. Carolina Pharmaceutical Research
state: South Carolina
city: Richmond
country: United States
facility: Pulmonary Associates of Richmond
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Tacoma
country: United States
facility: Multicare Institute For Research & Innovation
state: Washington
Study officials:
affiliation: Medical University of South Carolina, US
name: Gerard Silvestri, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.