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

• Register: ClinicalTrials.gov
• Last refreshed on: 15 April 2024
• Main ID: NCT03018756
• Date of registration: 20/12/2016
• Prospective Registration: Yes
• Primary sponsor: Dr. Denis O'Donnell
• Public title: Nebulized Fentanyl in Patients With Mild to Moderate Interstitial Lung Disease and Chronic Dyspnea
• Scientific title: Use of Nebulized Fentanyl in Patients With Mild-to-Moderate Interstitial Lung Disease and Chronic Dyspnea
• Date of first enrolment: January 2017
• Target sample size: 21
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03018756
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Canada

Contacts

• Name: Denis E O'Donnell, MD, FRCPC
• Affiliation: Queen's University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Fibrotic interstitial lung disease (ILD) diagnosis confirmed by specialty ILD clinic

- A total lung capacity (TLC) capacity (FVC) 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.

Exclusion Criteria:

- 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.



Age minimum: 40 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Interstitial Lung Disease

Intervention(s)

Drug: Fentanyl Citrate

Drug: Placebo

Primary Outcome(s)

Dyspnea intensity measured by the 10-point Borg Scale at a standardized time during cycle ergometer exercise [Time Frame: 10-minutes post-treatment]

Secondary Outcome(s)

Diaphragm electromyography (EMGdi) at a standardized time during cycle exercise [Time Frame: 10-minutes post-treatment]

Tidal volume at a standardized time during cycle exercise [Time Frame: 10-minutes post-treatment]

Ventilation at a standardized time during cycle exercise [Time Frame: 10-minutes post-treatment]

Inspiratory capacity at a standardized time during cycle exercise [Time Frame: 10-minutes post-treatment]

Breathing frequency at a standardized time during cycle exercise [Time Frame: 10-minutes post-treatment]

Secondary ID(s)

DMED-1921-16

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Boehringer Ingelheim