Interstitial Lung Disease study: Hyperoxia
Official title Skeletal Muscle Function in Interstitial Lung Disease
ClinicalTrials.gov ID: NCT03800017
What this study is testing
What is Hyperoxia?
This is an investigational breathing protocol being studied to see if it helps with symptoms of interstitial lung disease.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether leg muscle structure and fatigue affect breathing difficulty and exercise limits in ILD patients. It also looks at how extra oxygen might help.
- Who it's for
- You may be able to join if you have interstitial lung disease and can walk for a short time.
- What's involved
- You will have your leg muscles examined and tested for strength and fatigue. You may also breathe extra oxygen during some tests. Visits include medical checks and muscle tests.
- Time commitment
- The study lasts about a few weeks, with several visits for tests and oxygen breathing sessions.
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80. Healthy volunteers may be eligible.
You may be able to join if
- Age 40-80 years (inclusive)
- A multidisciplinary diagnosis of idiopathic pulmonary fibrosis (IPF), idiopathic fibrotic nonspecific interstitial pneumonia (NSIP), chronic...
- Fibrosis on high resolution computed tomography (HRCT): honeycombing, reticulation, or traction bronchiectasis
- Appropriate candidate for pulmonary rehabilitation
- 6 minute walk distance 50m or more
You likely can't join if
- Contraindication to exercise testing (e.g. significant cardiovascular, musculoskeletal, neurological disease)
- Other significant extra-pulmonary disease that, based on clinical assessment, could impair exercise capacity and/or oxygenation
- Forced vital capacity (FVC) less than 50% or Diffusion capacity for carbon monoxide (DLCO) less than 25%
- Concurrent or recent participation (less than 6 months) in a pulmonary rehabilitation program
- Use of prednisone greater than 10 mg/day for more than 2 weeks within 3 months of the first study visit
- Currently smoking or previously smoked more than 10 pack-years
See the full eligibility criteria
- Age 40-80 years (inclusive)
- A multidisciplinary diagnosis of idiopathic pulmonary fibrosis (IPF), idiopathic fibrotic nonspecific interstitial pneumonia (NSIP), chronic hypersensitivity pneumonitis (HP), or unclassifiable ILD with a differential...
- Fibrosis on high resolution computed tomography (HRCT): honeycombing, reticulation, or traction bronchiectasis
- Appropriate candidate for pulmonary rehabilitation
- 6 minute walk distance 50m or more
- Oxygen saturation ≥ 92% by pulse oximetry at rest while breathing room air
- Clinically stable for the preceding 6 weeks
- Age 40-80 (inclusive)
- Normal pulmonary function (80-120% predicted)
- No lung or cardiovascular disease
- Can fluently read and write in English
- Contraindication to exercise testing (e.g. significant cardiovascular, musculoskeletal, neurological disease)
- Other significant extra-pulmonary disease that, based on clinical assessment, could impair exercise capacity and/or oxygenation
- Forced vital capacity (FVC) less than 50% or Diffusion capacity for carbon monoxide (DLCO) less than 25%
- Concurrent or recent participation (less than 6 months) in a pulmonary rehabilitation program
- Use of prednisone greater than 10 mg/day for more than 2 weeks within 3 months of the first study visit
- Currently smoking or previously smoked more than 10 pack-years
- Any medical conditions that prevents them for exercising safely
- Cardiac pacemaker or any metal or electronic inside the body
The study team makes the final eligibility decision.
Where it is enrolling
- Vancouver, British Columbia, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Vancouver, British Columbia, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.