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Nebulized Fentanyl in Patients With Mild to Moderate Idiopathic Pulmonary Fibrosis and Chronic Dyspnea

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ClinicalTrials.gov Identifier: NCT03018756
Recruitment Status : Recruiting
First Posted : January 12, 2017
Last Update Posted : September 25, 2018
Sponsor:
Collaborator:
Boehringer Ingelheim
Information provided by (Responsible Party):
Dr. Denis O'Donnell, Queen's University

December 20, 2016
January 12, 2017
September 25, 2018
January 2017
July 2019   (Final data collection date for primary outcome measure)
Dyspnea intensity measured by the 10-point Borg Scale at a standardized time during treadmill 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 treadmill tests.
Same as current
Complete list of historical versions of study NCT03018756 on ClinicalTrials.gov Archive Site
  • Diaphragm electromyography (EMGdi) at a standardized time during treadmill exercise [ Time Frame: 10-minutes post-treatment ]
    EMGdi will be used as an index of inspiratory neural drive. Assessments will be compared at a standardized time (4-minutes) during both post-treatment constant-load treadmill tests.
  • Ventilation at a standardized time during treadmill exercise [ Time Frame: 10-minutes post-treatment ]
    Exercise measurements of minute ventilation will be compared at a standardized time (4-minutes) during both post-treatment constant-load treadmill tests.
  • Breathing frequency at a standardized time during treadmill exercise [ Time Frame: 10-minutes post-treatment ]
    Exercise measurements of breathing frequency (respiratory rate) will be compared at a standardized time (4-minutes) during both post-treatment constant-load treadmill tests.
  • Tidal volume at a standardized time during treadmill exercise [ Time Frame: 10-minutes post-treatment ]
    Exercise measurements of tidal volume will be compared at a standardized time (4-minutes) during both post-treatment constant-load treadmill tests.
  • Inspiratory capacity at a standardized time during treadmill exercise [ Time Frame: 10-minutes post-treatment ]
    Exercise measurements of inspiratory capacity will be compared at a standardized time (4-minutes) during both post-treatment constant-load treadmill tests.
Same as current
Not Provided
Not Provided
 
Nebulized Fentanyl in Patients With Mild to Moderate Idiopathic Pulmonary Fibrosis and Chronic Dyspnea
Use of Nebulized Fentanyl in Patients With Mild-to-Moderate Idiopathic Pulmonary Fibrosis and Chronic Dyspnea
Patients with idiopathic pulmonary fibrosis (IPF) 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 IPF, as well as examine the potential mechanisms of dyspnea relief.
Treatment with opioids can improve activity related dyspnea by reducing central respiratory neural drive. Inhaled fentanyl citrate is an opioid that is generally well tolerated and has been shown to effectively relieve respiratory discomfort without causing systemic side-effects, although its mechanism of action are poorly understood. Based on the current evidence, non-sedating, rapidly active inhaled fentanyl represents a possible alternative and effective treatment of severe dyspnea in patients with IPF who require urgent treatment. As such, the primary objective of this study is to examine the acute effects of nebulized fentanyl on dyspnea intensity and quality in patients with mild-to-moderate IPF, as well as examine the neurophysiological mechanisms of dyspnea relief during fentanyl inhalation. It is believed that fentanyl when compared with placebo, will reduce inspiratory neural drive to the diaphragm and breathing frequency, resulting in improvements in dyspnea intensity during physical exertion. Alternatively, dyspnea relief after inhaled fentanyl may be independent of changes in neural drive, and instead linked to the presence of opioid receptors in the lungs that modulate afferent inputs to the brain, thereby favourably influencing perceived dyspnea.
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Idiopathic Pulmonary Fibrosis
  • Drug: Fentanyl Citrate
    100 mcg fentanyl citrate will be inhaled via nebulizer.
    Other Name: inhaled fentanyl
  • Drug: Placebo
    0.9% saline solution will be inhaled via nebulizer
    Other Name: normal saline
  • Active Comparator: Fentanyl Citrate
    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.
    Intervention: Drug: Fentanyl Citrate
  • Placebo Comparator: Placebo
    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.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
Same as current
July 2019
July 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 ≤6.
  • 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 IPF that could contribute to dyspnea and exercise limitation.
  • History of allergy or adverse response to fentanyl.
  • Presence of important contraindications to clinical exercise testing, including inability to exercise because of neuromuscular or musculoskeletal disease(s).
  • Use of daytime 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.

Sexes Eligible for Study: All
40 Years and older   (Adult, Older Adult)
Yes
Contact: Megha Ibrahim Masthan 613-549-6666 ext 4314 mim5@queensu.ca
Canada
 
 
NCT03018756
DMED-1921-16
No
Not Provided
Plan to Share IPD: No
Dr. Denis O'Donnell, Queen's University
Queen's University
Boehringer Ingelheim
Principal Investigator: Denis E O'Donnell, MD, FRCPC Queen's University
Queen's University
September 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP