The Use of Intranasal Fentanyl for the Treatment of Incident Dyspnea in Congestive Heart Failure: A Prospective Trial

NCT02454751 | Completed Phase 2

• 1 other identifier: CTA/2014/002
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Study Objective The primary object of this study is to investigate the safety and effectiveness of fentanyl on the management of incident dyspnea. Study Design The study design will be a cross over study with a minimum of a one hour wash out period.

Conditions

Dyspnea; Congestive Heart Failure

Outcome Measures

Primary Outcomes (1)

• Walking distance from the 6MWT

  meters walked

  6 min

Secondary Outcomes (6)

• Subjective rating of dyspnea and side effects (Edmonton Symptom Assessment Scale)

  Day 1 - at time 0, 10 and 20 min Day 2 - at time 0, 10 and 20 min

• respiratory rate

  Day 1 - at time 0, 10 and 20 min Day 2 - at time 0, 10 and 20 min

• heart rate

  Day 1 - at time 0, 10 and 20 min Day 2 - at time 0, 10 and 20 min

• oxygen saturation

  Day 1 - at time 0, 10 and 20 min Day 2 - at time 0, 10 and 20 min

• blood pressure

  Day 1 - at time 0, 10 and 20 min Day 2 - at time 0, 10 and 20 min

Study Arms (1)

Pre-fentanyl dose/fentanyl dose

EXPERIMENTAL

Crossover: 6-six minute walk test, subjective rating of dyspnea, heart rate, respiratory rate, oxygen saturation and participants' general appearance measured before and after a dose of fentanyl.

Drug: fentanyl

Interventions

fentanyl DRUG

One time dose of 50mcg of fentanyl administered intranasally

Also known as: sublimaze

Pre-fentanyl dose/fentanyl dose

Eligibility Criteria

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

You may qualify if:

• Patients must be experiencing activity-induced incident dyspnea without reversible causes. They would have controlled background dyspnea without opioids.
• Patients must be physically able to safely ambulate in order to complete the 6MWT (may have mobility devices and may use supplement oxygen prescribed pre-study).

You may not qualify if:

• Patients who are unable to perform the 6MWT for any reason or have contraindications to performing the 6MWT
• Patients that have anatomical pathologies that would make intranasal administration impossible
• Patients with known allergies/sensitivities to fentanyl/sufentanil

Sponsors & Collaborators

• St. Boniface Hospital: lead

Study Sites (1)

St. Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

MeSH Terms

Conditions

Dyspnea; Heart Failure

Interventions

Fentanyl

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jana Pilkey, MD

  St. Boniface Hosptial

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: May 19, 2015
• First Posted: May 27, 2015
• Study Start: October 1, 2015
• Primary Completion: June 30, 2017
• Study Completion: September 15, 2017
• Last Updated: September 28, 2017

Record last verified: 2017-09

Locations

CA (1)