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New treatment option for Idiopathic Pulmonary Fibrosis
Official title Pilot Study of Nitrate-rich Beetroot Juice Supplementation in Patients With Idiopathic Pulmonary Fibrosis (IPF)
ClinicalTrials.gov ID: NCT06488638
What this study is testing
- What it's testing
- Idiopathic pulmonary fibrosis (IPF) is a type of scarring (fibrotic) lung disease. Reduced exercise capacity is a key symptom experienced by patients.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. 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 18 to 85. Healthy volunteers may be eligible.
You may be able to join if
- IPF Patients: 1. Patients aged 18-85 years with a prior specialist multidisciplinary team diagnosis of idiopathic pulmonary fibrosis (IPF) based on...
- Medical Research Council (MRC) breathlessness grade 1-3
- Judged clinically stable for 3 months prior to recruitment by the investigator. IPF Patients:
You likely can't join if
- Baseline spirometry with FEV1/FVC ratio \< 0.7.
- Neoplastic disease undergoing treatment or active follow up.
- Presence of infection or exacerbation requiring hospitalization, within last 3 months.
- Current tobacco smoker or use of nicotine containing vapes (within 3 months)
- Current use of ambulatory or long-term oxygen therapy (LTOT).
- Peripheral oxygen saturations \<85% during 6-minute walk-test.
See the full eligibility criteria
- IPF Patients: 1. Patients aged 18-85 years with a prior specialist multidisciplinary team diagnosis of idiopathic pulmonary fibrosis (IPF) based on current established consensus guidelines.
- Medical Research Council (MRC) breathlessness grade 1-3
- Judged clinically stable for 3 months prior to recruitment by the investigator. IPF Patients:
- Baseline spirometry with FEV1/FVC ratio \< 0.7.
- Neoplastic disease undergoing treatment or active follow up.
- Presence of infection or exacerbation requiring hospitalization, within last 3 months.
- Current tobacco smoker or use of nicotine containing vapes (within 3 months)
- Current use of ambulatory or long-term oxygen therapy (LTOT).
- Peripheral oxygen saturations \<85% during 6-minute walk-test.
- Any condition which would prevent completion of cycle-ergometer testing, pulmonary function testing (PFT) or 6-minute walk testing as judged by the investigator.
- Participation in a pulmonary rehabilitation (PR) program in the last 3 months.
- Any condition excluding CPET based on the absolute contraindication as the ACCP/ATS guidelines 2003
- Positive pregnancy test in females of childbearing age.
- Symptomatic peripheral vascular disease
- Concomitant use of nitrate-based medicine or phosphodiesterase V inhibitors Controls: Inclusion Criteria 1) Age and sex-matched to participants in the IPF cohort. Note: the participants will be age-matched within a...
- Inability to give informed written consent.
- Malignancy (except localised squamous or basal cell skin carcinoma) undergoing active investigation, treatment, or follow-up.
- Significant cardiorespiratory disease as judged by the investigator.
- Diabetes mellitus requiring treatment with pharmacology therapy.
- Current tobacco smoker or use of nicotine containing vapes (within three months).
- Symptomatic peripheral vascular disease.
- Concomitant use of nitrate-based medicine or phosphodiesterase V inhibitors.
The study team makes the final eligibility decision.
Where it's taking place
- Southampton, United Kingdom
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, 18 years to 85 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Southampton, United Kingdom. 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.