Trial intelligence / Profile preview

Nebulized Fentanyl for Dyspnea in ILD

NCT03018756Phase 3

Key facts

Status: Completed
Start: Jan 2017
Primary completion: Jun 2018
Countries: 1
Modality: Orthosteric Ligands

Drugs: fentanyl
Conditions: interstitial lung disease (ILD)

Overview

Phase 3, randomised, double-blind trial in interstitial lung disease (ILD) comparing Fentanyl Citrate First with Placebo First (2 arms). Primary endpoint: Dyspnea intensity measured by the 10-point Borg Scale. Started Jan 2017; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Fentanyl Citrate First
Fentanyl Citrate in Period 1, then Placebo in Period 2
Placebo First
Placebo in Period 1, then Fentanyl Citrate in Period 2

Who it enrols

Patients with fibrotic interstitial lung disease, moderate-to-severe chronic activity-related dyspnea, and specific lung function criteria. Excludes patients on ambulatory oxygen, with BMI <18.5 or >=35, or recent use of opioids or antidepressants.

Endpoints

Primary

Dyspnea intensity measured by the 10-point Borg Scale10-minutes post-treatment

Secondary

Diaphragm electromyography (EMGdi)10-minutes post-treatment
Ventilation10-minutes post-treatment
Breathing frequency10-minutes post-treatment
Tidal volume10-minutes post-treatment
Inspiratory capacity10-minutes post-treatment

Results

Not all primary endpoints met

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