Nebulized Fentanyl in Patients With Mild to Moderate Interstitial Lung Disease and Chronic Dyspnea

NCT03018756 | Completed Phase 3

• 1 other identifier: DMED-1921-16
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with interstitial lung disease (ILD) experience distressing activity-related respiratory discomfort which is challenging to manage therapeutically. Interventions such as pulmonary rehabilitation, collaborative self-management, supplemental oxygen therapy and oral opiate medications, are variably effective and therapeutic responses to each in individual patients are difficult to predict. The purpose of this study is to evaluate the acute effects of inhaled opiate therapy (fentanyl citrate) on breathing discomfort (dyspnea) in individuals with mild-to-moderate ILD, as well as examine the potential mechanisms of dyspnea relief.

Conditions

Interstitial Lung Disease

Outcome Measures

Primary Outcomes (1)

• Dyspnea intensity measured by the 10-point Borg Scale at a standardized time during cycle ergometer exercise

  The 10-point Borg scale ranges from 0 "nothing at all" to 10 "maximal/extremely strong" and will be used to rate the intensity of dyspnea during exercise: a decrease in this rating signifies an improvement. Dyspnea intensity will be assessed at a standardized time (4-minutes) in both post-treatment constant-load cycle ergometer tests.

  10-minutes post-treatment

Secondary Outcomes (5)

• Diaphragm electromyography (EMGdi) at a standardized time during cycle exercise

  10-minutes post-treatment

• Ventilation at a standardized time during cycle exercise

  10-minutes post-treatment

• Breathing frequency at a standardized time during cycle exercise

  10-minutes post-treatment

• Tidal volume at a standardized time during cycle exercise

  10-minutes post-treatment

• Inspiratory capacity at a standardized time during cycle exercise

  10-minutes post-treatment

Study Arms (2)

Fentanyl Citrate

ACTIVE COMPARATOR

Single dose, nebulized 100 mcg fentanyl citrate. This is a double-blind, placebo-controlled, two-period crossover study comparing the effects of a single dose of nebulized 100 mcg fentanyl citrate to that of a placebo (0.9% saline). Treatments will be in randomized order: patients in one study arm will receive fentanyl at the first treatment visit and placebo at the second treatment visit, patients in the other arm will receive placebo first and fentanyl second.

Drug: Fentanyl Citrate

Placebo

PLACEBO COMPARATOR

Single dose, nebulized 0.9% saline solution. This is a double-blind, placebo-controlled, two-period crossover study comparing the effects of a single dose of nebulized 100 mcg fentanyl citrate to that of a placebo (0.9% saline). Treatments will be in randomized order: patients in one study arm will receive fentanyl at the first treatment visit and placebo at the second treatment visit, patients in the other arm will receive placebo first and fentanyl second.

Drug: Placebo

Interventions

Fentanyl Citrate DRUG

100 mcg fentanyl citrate will be inhaled via nebulizer.

Also known as: inhaled fentanyl

Fentanyl Citrate

Placebo DRUG

0.9% saline solution will be inhaled via nebulizer

Also known as: normal saline

Placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fibrotic interstitial lung disease (ILD) diagnosis confirmed by specialty ILD clinic
• A total lung capacity (TLC) \<lower limit of normal and ≥60%predicted, a forced vital capacity (FVC) \<lower limit of normal and ≥60%predicted, and a forced expiratory volume in 1 second (FEV1)/FVC \>70%.
• Clinically stable as defined by no changes in medication dosage or frequency of administration with no exacerbations or hospital admissions in the preceding 6 weeks.
• Moderate-to-severe chronic activity related dyspnea as defined by a Baseline Dyspnea Index total score ≤9, modified Medical Research Council score \>1, or oxygen cost diagram.
• Ability to perform all study procedures and provide/sign informed consent.

You may not qualify if:

• Women of childbearing age who are pregnant or trying to become pregnant.
• Diffusing capacity of the lung for carbon monoxide (DLCO) \<40 %predicted.
• Presence of active cardiopulmonary disease other than ILD that could contribute to dyspnea and exercise limitation.
• History of allergy or adverse reaction to fentanyl.
• History of allergy or adverse reaction to latex
• Presence of contraindications to pulmonary function or clinical exercise testing, including inability to exercise because of neuromuscular or musculoskeletal disease(s).
• Use of ambulatory oxygen or exercise-induced oxygen desaturation to \< 80% on room air.
• Body mass index (BMI) \<18.5 or ≥35.0 kg/m2.
• Use of antidepressant drugs (i.e., monoamine oxidase inhibitors, serotonin reuptake inhibitors) in the previous 2 weeks.
• Use of opioid drugs (e.g., morphine, fentanyl, oxycodone, codeine, etc.) in the previous 4 weeks.
• Note: Healthy volunteers will only be used to assist in the characterization of the IPF study group, i.e., for comparison of baseline exercise responses. They will not undergo treatment.

Sponsors & Collaborators

• Dr. Denis O'Donnell: lead
• Boehringer Ingelheim: collaborator

Study Sites (1)

Respiratory Investigation Unit, Queen's University

Kingston, Ontario, K7L 2V7, Canada

Location

MeSH Terms

Conditions

Lung Diseases, Interstitial

Interventions

Fentanyl; Saline Solution

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Denis E O'Donnell, MD, FRCPC

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 20, 2016
• First Posted: January 12, 2017
• Study Start: January 1, 2017
• Primary Completion: June 25, 2018
• Study Completion: November 30, 2020
• Last Updated: April 3, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)