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

This study is currently recruiting participants.
Verified January 2017 by Dr. Denis O'Donnell, Queen's University
Sponsor:
ClinicalTrials.gov Identifier:
NCT03018756
First Posted: January 12, 2017
Last Update Posted: January 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Boehringer Ingelheim (Canada) LTD
Information provided by (Responsible Party):
Dr. Denis O'Donnell, Queen's University
  Purpose
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.

Condition Intervention Phase
Idiopathic Pulmonary Fibrosis Drug: Fentanyl Citrate Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of Nebulized Fentanyl in Patients With Mild-to-Moderate Idiopathic Pulmonary Fibrosis and Chronic Dyspnea

Resource links provided by NLM:


Further study details as provided by Dr. Denis O'Donnell, Queen's University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 20
Study Start Date: January 2017
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Fentanyl Citrate
100 mcg fentanyl citrate will be inhaled via nebulizer.
Other Name: inhaled fentanyl
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.
Drug: Placebo
0.9% saline solution will be inhaled via nebulizer
Other Name: normal saline

Detailed Description:
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03018756


Contacts
Contact: Kathy Webb, M.Sc. 613-549-6666 ext 4950 kw2@queensu.ca

Locations
Canada, Ontario
Respiratory Investigation Unit, Queen's University Recruiting
Kingston, Ontario, Canada, K7L 2V7
Contact: Kathy Webb, M.Sc.    613-549-6666 ext 4950    kw2@queensu.ca   
Principal Investigator: Denis E O'Donnell, MD, FRCPC         
Sponsors and Collaborators
Queen's University
Boehringer Ingelheim (Canada) LTD
Investigators
Principal Investigator: Denis E O'Donnell, MD, FRCPC Queen's University
  More Information

Responsible Party: Dr. Denis O'Donnell, Principal Investigator, Queen's University
ClinicalTrials.gov Identifier: NCT03018756     History of Changes
Other Study ID Numbers: DMED-1921-16
First Submitted: December 20, 2016
First Posted: January 12, 2017
Last Update Posted: January 12, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Dyspnea
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms
Fentanyl
Citric Acid
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action