Mechanisms of Exertional Dyspnea in Fibrotic Interstitial Lung Disease (Dyspnea_ILD)
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|ClinicalTrials.gov Identifier: NCT01781793|
Recruitment Status : Completed
First Posted : February 1, 2013
Last Update Posted : October 12, 2016
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 or disease||Intervention/treatment||Phase|
|Lung; Disease, Interstitial, With Fibrosis||Other: Room air Other: Hyperoxia||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||Mechanisms of Exertional Dyspnea in Fibrotic Interstitial Lung Disease|
|Study Start Date :||September 2013|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||April 2016|
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
60% oxygen will be inspired
- 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. ]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).
- 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. ]
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): NCT01781793
|Canada, British Columbia|
|UBC James Hogg Research Centre, St. Paul's Hospital|
|Vancouver, British Columbia, Canada, V6Z1Y6|
|Principal Investigator:||Jordan A Guenette, PhD||UBC James Hogg Research Centre|