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Mechanisms of Exertional Dyspnea in Fibrotic Interstitial Lung Disease (Dyspnea_ILD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01781793
First received: January 28, 2013
Last updated: October 11, 2016
Last verified: October 2016
  Purpose

Exertional dyspnea is a major source of crippling distress and is the hallmark symptom of fibrotic interstitial lung disease (ILD). Due to the scientific community's poor understanding of the pathophysiological mechanisms of dyspnea there are no therapeutic interventions that consistently reduce dyspnea in this population. The investigators aim to determine the physiological mechanisms of exertional dyspnea in patients with fibrotic ILD and the impact of hyperoxia on exertional dyspnea and exercise endurance. This study will likely identify an important physiological mechanism of dyspnea in fibrotic ILD and may contribute to the development of effective therapies to reduce dyspnea in this population.

The central hypothesis is that dyspnea in fibrotic ILD is primarily a result of an imbalance between the drive to breathe and the tidal volume response of the respiratory system (i.e., neuromechanical uncoupling) and that experimental reduction of neuromechanical uncoupling via hyperoxic breathing will reduce exertional dyspnea and improve exercise endurance.


Condition Intervention
Lung; Disease, Interstitial, With Fibrosis
Other: Room air
Other: Hyperoxia

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Mechanisms of Exertional Dyspnea in Fibrotic Interstitial Lung Disease

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • To determine the physiological mechanisms of exertional dyspnea (Aim 1) and the effects of hyperoxia on dyspnea and cycle endurance in patients with fibrotic ILD (Aim 2) [ Time Frame: Parameters will be measured during the four visits. Each visit is separated by at least 48 hours and all visits will be completed within 8 weeks. During the course of each visit, parameters will be measured at rest and during the exercise intervention. ] [ Designated as safety issue: No ]
    Included will be 16 patients with fibrotic ILD who have no other pulmonary or extra-pulmonary limitation to exercise. Patients will perform an incremental symptom-limited cardio-pulmonary exercise test while detailed ventilatory, metabolic, respiratory mechanical, neuromechanical and sensory responses are measured. Patients will perform a cross-over study with two symptom-limited constant-load cycle exercise tests on separate days at 75% of peak incremental work rate. These tests will be performed breathing room air on one visit and hyperoxia on the other. Detailed physiological and sensory responses will be measured. Multivariate linear regression will be used to identify the association between neuromechanical uncoupling and exertional dyspnea, adjusting for the individual components of neuromechanical uncoupling (i.e., drive to breathe and tidal volume response) (Aim 1). Paired t-tests will be used to compare outcomes between room air and hyperoxic tests (Aim 2).


Secondary Outcome Measures:
  • To determine the mechanism by which hyperoxia improves exertional dyspnea and exercise time [ Time Frame: Parameters will be measured during the four visits. Each visit is separated by at least 48 hours and all visits will be completed within 8 weeks. During the course of each visit, parameters will be measured at rest and during the exercise intervention. ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: September 2013
Study Completion Date: April 2016
Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Fibrotic ILD Patients, Room Air
Fibrotic ILD patients will breathe room air (21% oxygen) during a constant work rate exercise test
Other: Room air
Humidified room air (21% oxygen) will be inspired
Active Comparator: Fibrotic ILD Patients, Hyperoxia
Fibrotic ILD patients will breathe hyperoxia (60% oxygen) during a constant work rate exercise test
Other: Hyperoxia
60% oxygen will be inspired

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria - Fibrotic ILD participants:

  • A multidisciplinary diagnosis of idiopathic pulmonary fibrosis (IPF), idiopathic fibrotic non-specific interstitial pneumonia (NSIP), chronic hypersensitivity pneumonitis (HP), or unclassifiable interstitial lung disease (ILD) with a differential diagnosis that consists of the above diagnoses
  • Fibrosis on high resolution computed tomography (HRCT): honeycombing, reticulation, or traction bronchiectasis
  • Oxygen saturation ≥ 92% by pulse oximetry at rest while breathing room air

Exclusion Criteria - Fibrotic ILD Participants:

  • Concurrent participation in or recent completion (less than 6 weeks) of pulmonary rehabilitation
  • A significant lung disease other than fibrotic ILD that, based on clinical assessment, could impair your ability to exercise
  • Significant emphysema
  • Pulmonary hypertension (high blood pressure in your lungs' arteries)
  • Prednisone (a corticosteroid medication) in excess of 10mg/day for at least two weeks within three months of the first study visit
  • An ulcer or tumor in your esophagus, or a nasal septum deviation
  • Had recent nasopharyngeal surgery
  • A cardiac pacemaker
  • Allergies to latex and sensitivities to local anaesthetics
  • Current smokers or smoked more than 20 packs per year in the past
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01781793

Locations
Canada, British Columbia
UBC James Hogg Research Centre, St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z1Y6
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Jordan A Guenette, PhD UBC James Hogg Research Centre
  More Information

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01781793     History of Changes
Other Study ID Numbers: H13-00059 
Study First Received: January 28, 2013
Last Updated: October 11, 2016
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
dyspnea, exercise endurance, lung disease

Additional relevant MeSH terms:
Lung Diseases
Dyspnea
Lung Diseases, Interstitial
Respiratory Tract Diseases
Respiration Disorders
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on December 05, 2016