Evaluation of Oxygen Therapy on Physical Activity in Patients with Fibrotic Interstitial Lung Disease and Exertional Hypoxemia

The primary objective of this study is to assess the **feasibility** of oxygen therapy during exertion in patients with fibrotic interstitial lung disease (ILD) and exertional hypoxemia. This is measured by the change in physical activity, specifically steps per day, using an accelerometer at one month and after three months of follow-up. The clinical relevance of this objective lies in determining whether oxygen therapy can enhance physical activity levels, which is crucial for improving overall health outcomes in patients with fibrotic ILD.

Secondary objectives include:

• Evaluating changes in the degree of dyspnea, quality of life, and symptoms of anxiety and depression in patients with fibrotic ILD and exertional hypoxemia at one month and after three months of follow-up.
• Assessing changes in oxidative stress in peripheral blood of patients receiving supplemental oxygen during exercise compared to controls without supplemental oxygen at three months of follow-up.
• Evaluating compliance with oxygen therapy during exertion in patients with fibrotic ILD and exertional hypoxemia at one month and after three months of follow-up.

The clinical trial involves participants diagnosed with **fibrotic interstitial lung disease** (ILD), specifically those experiencing exertional hypoxemia, as indicated by a minimum SpO2 of 88% during the 6-minute walk test (6MWT) performed in room air. The study population includes both male and female subjects aged 18 years and older. Participants were selected based on the presence of fibrotic ILD, characterized by peripheral reticulation, traction bronchiectasis, volume loss, and/or honeycombing on high-resolution chest CT (HRCT). The trial does not involve a vulnerable population. The sponsor has not provided information regarding the total number of participants. The study does not specify any particular lifestyle considerations such as diet or physical activity habits beyond the focus on exertional hypoxemia. Key inclusion criteria include the stability of respiratory symptoms for at least two weeks prior to inclusion in the study.

The clinical trial is designed to evaluate the impact of **oxygen therapy** on exertion in physical activity among patients with **fibrotic interstitial lung disease** and exertional hypoxemia. This study is a randomized, double-blind, controlled trial with a duration of approximately two years, from March 2024 to March 2026. The trial aims to assess changes in physical activity, measured by steps per day, and other health parameters over a three-month period. Participants will be randomly assigned to either the intervention group receiving oxygen therapy or a control group.

The sequence of study visits begins with an inclusion (screening) visit, where eligibility is confirmed based on criteria such as age (≥18 years), a diagnosis of fibrotic interstitial lung disease, and a minimum SpO2 ≤ 88% during a six-minute walk test. Following the screening, participants will undergo baseline assessments before randomization. Subsequent follow-up visits will occur at one month and three months to monitor changes in physical activity, dyspnea, quality of life, and other secondary endpoints. The end-of-study visit will conclude the trial, where final assessments will be conducted.

Participant involvement is expected to last for a maximum of three months, with the possibility of early termination if any exclusion criteria are met post-randomization or if the participant experiences adverse effects that compromise safety. The primary endpoint is the change in the number of steps per day between the control and intervention groups. Secondary endpoints include changes in dyspnea, quality of life, anxiety, depression, and compliance with oxygen therapy. The trial is classified as a low-intervention study, as the investigational product, oxygen, is used according to its authorized marketing terms and supported by existing scientific evidence.

The clinical trial involves the administration of **oxygen** as the experimental medication. The pharmaceutical form of the medication is a **medicinal gas, compressed**, and it is administered via the **inhalation gas** route. The dosage is specified as a maximum of 4 liters per day, with the total maximum dose also being 4 liters. The treatment period is limited to a maximum of 3 days. The active substance, **oxygen**, is of chemical origin and is utilized in the context of **oxygen therapy**. The trial aims to evaluate the impact of this therapy on exertion in physical activity among patients with fibrotic interstitial lung disease and exertional hypoxemia.

The efficacy of oxygen therapy in patients with fibrotic interstitial lung disease (ILD) with exertional hypoxemia will be assessed through a series of primary and secondary endpoints. The primary endpoint is the change in the number of steps per day, comparing the control group and the intervention group. This will be measured using an accelerometer to track physical activity, specifically steps per day, at one month and after three months of follow-up.

Secondary endpoints include changes in dyspnea as measured by the Dyspnea-12 questionnaire, quality of life assessed by the K-BILD questionnaire, and anxiety and depression evaluated using the HADS scale. Additionally, the study will evaluate the hours per day of oxygen therapy compliance and analyze changes in oxidative stress between the control and intervention groups. These assessments will provide a comprehensive evaluation of the impact of oxygen therapy on patients' physical activity and overall well-being.