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BronchoscopyPhase 3NCT02296892

A Phase III Study of Remimazolam in Patients Undergoing Bronchoscopy

A Phase 3 study testing Remimazolam and Midazolam in people with Bronchoscopy, run by Paion UK Ltd. at 14 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bronchoscopy
What is being tested?
Remimazolam and Midazolam
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
446 participants
Where
14 sitesUnited States
Study dates
Apr 2015to 13 Mar 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
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  • 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).

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

United States14 sites

  • The Johns Hopkins Center for Interventional and Pulmonary Care

    Baltimore, Maryland, 21287

  • Pab Clinical Research

    Brandon, Florida, 33511

  • Unc Division of Pulmonary and Critical Care

    Chapel Hill, North Carolina, 27599

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Duke University

    Durham, North Carolina, 27710

  • Laporte County Institute For Clinical Research

    Michigan City, Indiana, 46360

  • Pinehurst Medical Clinic

    Pinehurst, North Carolina, 28374

  • Pulmonary Associates of Richmond

    Richmond, Virginia, 23225

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • S. Carolina Pharmaceutical Research

    Spartanburg, South Carolina, 29303

  • Washington University School of Medicine/Barnes-Jewish Hospital

    St Louis, Missouri, 63110

  • Sun City Office

    Sun City Center, Florida, 33573

  • Multicare Institute For Research & Innovation

    Tacoma, Washington, 98405

  • Wake Forest Baptist Health

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

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

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
Being tested
Remimazolam, Placebo, Midazolam
Keywords
Remimazolam, midazolam, bronchoscopy, procedural sedation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RemimazolamDrug

    Also called CNS7056

    For induction and maintenance of sedation

  • PlaceboDrug

    Inactive control arm

  • MidazolamDrug

    Also called Versed

    For induction and maintenance of sedation

Study groups in NCT02296892
Study groupRoleWhat they receive
RemimazolamExperimentalDouble-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
Receives: Drug: Remimazolam
PlaceboPlacebo comparatorDouble-blind placebo arm as inactive control Fentanyl pre-treatment: 25-50 μg (or less for elderly/disabled subjects), and 25 μg top-up doses
Receives: Drug: Placebo
MidazolamActive comparatorOpen-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
Receives: Drug: Midazolam

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (3)

  1. Time to Start of Procedure

    The time from the first dose of study drug until bronchoscope insertion on Day 1

    Measured: From first dose of study drug until insertion of the bronchoscope

  2. 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.

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

  3. 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)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Nov 2014 (estimated)
  2. Study startApr 2015
  3. Primary completionMar 2017
  4. Study completion13 Mar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
446 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02296892
Sponsor's protocol ID
CNS7056-008
Status last verified
Mar 2020
First submitted
11 Nov 2014
Last updated
18 Mar 2020
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 30292760

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Remimazolam and Midazolam in people with Bronchoscopy, run by Paion UK Ltd. at 14 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With a Successful Procedure (time frame: From first dose of study drug to removal of bronchoscope (average time not known)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02296892, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2020.

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