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New treatment option for Interstitial Lung Disease
Official title Skeletal Muscle Function in Interstitial Lung Disease
ClinicalTrials.gov ID: NCT03800017
What this study is testing
What is Hyperoxia?
Hyperoxia is an investigational medicine, given as an injection into a muscle, being studied as a potential treatment for 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
- Dyspnea (i.e. breathlessness) and exercise intolerance are common symptoms for patients with interstitial lung disease (ILD), yet it is not known why.
- 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
- for ILD Patients:
- 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
You likely can't join if
- for the ILD patients:
- 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
See the full eligibility criteria
- for ILD Patients:
- 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
- Can fluently read and write in English for Healthy Controls:
- Age 40-80 (inclusive)
- Normal pulmonary function (80-120% predicted)
- No lung or cardiovascular disease
- Can fluently read and write in English
- for the ILD patients:
- 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
- Significant emphysema (less than 10% volume on HRCT or FEV1/FVC less than 0.70) Exclusion Criteria for Healthy Controls:
- 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's taking place
- 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 - 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?
Study sites include Vancouver, British Columbia, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.