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NCT03018756
Use of Nebulized Fentanyl in Patients With Mild-to-Moderate Interstitial Lung Disease and Chronic Dyspnea
Phase 3 trial testing Fentanyl Citrate in Interstitial Lung Disease in 21 participants. Completed in 30 November 2020.
25 June 2018
Quick facts
| Lead sponsor | Dr. Denis O'Donnell |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 21 |
| Start date | 1 January 2017 |
| Primary completion | 25 June 2018 |
| Estimated completion | 30 November 2020 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Fentanyl Citrate — full drug profile →
- Placebo
Conditions studied
- Interstitial Lung Disease — all drugs for Interstitial Lung Disease →
Sponsor
Dr. Denis O'Donnell
Who can join
40 and older, any sex, with Interstitial Lung Disease. Healthy volunteers can join.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Dyspnea intensity measured by the 10-point Borg Scale at a standardized time during cycle ergometer exercise
Time frame: 10-minutes post-treatment
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.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Emerging therapies for idiopathic pulmonary fibrosis, a progressive age-related disease.
Mora AL, Rojas M, Pardo A, Selman M. · · 2017 · cited 99× · PMID 29081515 · DOI 10.1038/nrd.2017.225
Verify or expand the search:
- PubMed search for NCT03018756
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Fentanyl Citrate
Trials testing the same drug.
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- NCT06017141 — Inhalational or Intravenous Anesthesia During Surgery for Patients With Colon Cancer, VIVA Study · Phase 2 · recruiting
- NCT05500599 — Effects on Recovery of Children of Intravenous Formulation of Fentanyl Citrate and Midazolam Orally for Premedication · NA · active not recruiting
- NCT05051189 — Effect of Opioids on Central Control of Ventilation in Children With Obstructive Sleep Apnea · EARLY_PHASE1 · completed
- NCT04645823 — Spinal Fentanyl or Epidural Analgesia in the Early First Phase of Induced Labor · Phase 4 · completed
Other recruiting trials for Interstitial Lung Disease
Currently open trials in the same condition.
- NCT07451977 — Effects of Oxygen Supplementation During the 6-Minute Walk Test in Chronic Respiratory Failure or Exertional Hypoxemia · NA · recruiting
- NCT07254338 — Exploration of Metabolome in Patients With Interstitial Lung Disease and Pulmonary Hypertension With or Without Specific · recruiting
- NCT07269262 — SUPPORT-T in Patients With Progressive Pulmonary Fibrosis and Their Caregivers · NA · recruiting
- NCT07179380 — Efficacy and Safety Study of Treprostinil Palmitil Inhalation Powder (TPIP) in Participants With Pulmonary Hypertension · Phase 3 · recruiting
- NCT07323732 — A Study of BIO 300 and Thoracic Radiation Therapy in People With Non-Small Cell Lung Cancer and Interstitial Lung Diseas · Phase 2 · recruiting
Other Dr. Denis O'Donnell trials
Trials by the same sponsor.
- NCT05052229 — Inhaled Nitric Oxide (iNO) in Idiopathic Pulmonary Fibrosis (IPF). · EARLY_PHASE1 · recruiting
- NCT04069052 — The Effect of Inhaled Nitric Oxide on Deadspace in COPD · EARLY_PHASE1 · completed
- NCT04920695 — Inhaled Nitric Oxide (iNO) in Post-Pulmonary Embolism (Post-PE) · NA · completed
- NCT03786367 — Dyspnea in Chronic Thromboembolic Pulmonary Hypertension · completed
- NCT03405090 — Differential Mechanisms of Dyspnea Relief in Advanced COPD: Opiates vs. Bronchodilators · Phase 4 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03018756 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Dr. Denis O'Donnell
- Last refreshed: 1 April 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03018756.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing