OXYGEN for Fibrotic interstitial lung disease

Inclusion criteria

• {"criterion_text":"- Patients aged greater than or equal to 18 years.\n- Patients with a diagnosis of fibrotic ILD, defined by the presence of peripheral reticulation, traction bronchiectasis, volume loss and/or presence of “honeycombing” on high-resolution chest CT (HRCT).\n- Patients with minimum SpO2 ≤ 88% in the 6MWT performed in room air.\n- Stability of respiratory symptoms two weeks prior to inclusion."}

Exclusion criteria

• {"criterion_text":"- SpO2 ≤ 93% at rest\n- Coexistence of other respiratory diseases such as COPD or asthma\n- Moderate-severe pulmonary hypertension measured by transthoracic echocardiography\n- Cardiological, osteo-articular or cognitive comorbidities that prevent correct performance of the 6MWT or a correct measurement of daily physical activity\n- Diagnosis of neoplasia in active treatment\n- Hospital admission 2 months prior to inclusion in the study\n- Current smoker\n- Being in a current pulmonary rehabilitation program"}

Primary endpoints

• {"endpoint_text":"- Change in the number of steps per day comparing the control group and the intervention group.","definition_or_measurement_approach":"Change in steps/day measured by accelerometer (steps/day) comparing control and intervention groups at one month and three months of follow-up."}

Secondary endpoints

• {"endpoint_text":"- Changes in dyspnea questionnaire (dyspnea-12), quality of life (K-BILD) and anxiety and depression (HADS) between control and intervention group","definition_or_measurement_approach":"Measured using dyspnea-12 questionnaire, K-BILD for quality of life, and HADS for anxiety and depression comparing control and intervention groups."}
• {"endpoint_text":"- Evaluate hours per day of oxygen therapy compliance","definition_or_measurement_approach":"Assessment of hours per day of oxygen therapy compliance (hours/day) comparing groups."}
• {"endpoint_text":"- Analytical changes in oxidative stress between contol and intervention group","definition_or_measurement_approach":"Analytical measurement of oxidative stress in peripheral blood comparing patients with supplemental oxygen during exercise and controls at three months of follow-up."}

Spain

Earliest CTIS Part Ii Submission Date

10-05-2024

Latest Decision Or Authorization Date

24-05-2024

Processing Time Days

14

Number Of Sites

1

Number Of Participants

36

Primary sponsor

Full Name

Consorci Mar Parc De Salut De Barcelona

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain