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Lung; Disease, Interstitial, With Fibrosis | Mechanisms of Exertional Dyspnea in Fibrotic Interstitial Lung Disease

Lung; Disease, Interstitial, With Fibrosis research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Lung; Disease, Interstitial, With Fibrosis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Other:Room airHumidified room air (21% oxygen) will be inspired

Other:Hyperoxia60% oxygen will be inspired

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Fibrotic ILD Patients, Room AirFibrotic ILD patients will breathe room air (21% oxygen) during a constant work rate exercise test

Fibrotic ILD Patients, HyperoxiaFibrotic ILD patients will breathe hyperoxia (60% oxygen) during a constant work rate exercise test

Study Status

Completed

Start Date: September 2013

Completed Date: April 2016

Phase: N/A

Type: Interventional

Design:

Primary Outcome: 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)

Secondary Outcome: To determine the mechanism by which hyperoxia improves exertional dyspnea and exercise time

Study sponsors, principal investigator, and references

Principal Investigator: Jordan A Guenette, PhD

Lead Sponsor: University of British Columbia

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01781793

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