OXYGEN for Interstitial lung disease (ILD)

Inclusion criteria

• {"criterion_text":"- Age > 30 years\n- Diagnosis of Interstitial Lung Disease (ILD) according to national and international guidelines\n- Signed informed consent form (Annex 1)"}

Exclusion criteria

• {"criterion_text":"- Participation in a Respiratory Rehabilitation (RR) program (including training) in the last 6 months\n- Intolerance to the high-flow oxygen administration system; while no cases have been reported to date (Frat et al, New Engl J of Med 2015; 372: 2185-96; Stephan et al, JAMA 2015; 313: 2331-39)\n- Respiratory diseases other than ILD\n- Severe cardiac, neuromuscular, anemia, vascular diseases, or other serious comorbidities (primarily severe pulmonary hypertension per SEPAR Guidelines 2017)\n- Osteoarticular diseases that hinder exercise performance\n- Terminal illness (inability to perform exercises or treatment with opioids)\n- Life expectancy < 6 months\n- Cognitive disorders that prevent active participation"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint will be the average SpO₂ achieved throughout the entire training period, comparing both groups.","definition_or_measurement_approach":"Average SpO₂ achieved throughout the entire training period (comparison between the two groups)."}

Secondary endpoints

• {"endpoint_text":"- Dyspnea during daily life activities (mMRC scale, dyspnea domain of the CRQ)","definition_or_measurement_approach":"Measured using the mMRC scale and the dyspnea domain of the Chronic Respiratory Questionnaire (CRQ)."}
• {"endpoint_text":"- Dyspnea during exertion before and after the 6-minute walk test (6MWT) (Borg scale)","definition_or_measurement_approach":"Measured using the Borg scale before and after the 6-minute walk test (6MWT)."}
• {"endpoint_text":"- Exercise capacity measured by the 6MWT without oxygen support","definition_or_measurement_approach":"Measured as distance walked in the 6-minute walk test (6MWT) without oxygen support."}
• {"endpoint_text":"- Health-Related Quality of Life (HRQoL) assessed using the KBILD and SF36 questionnaires","definition_or_measurement_approach":"Measured using the KBILD questionnaire and the SF-36 instrument."}
• {"endpoint_text":"- Full pulmonary function test (spirometry, lung volumes, diffusion, and blood gases)","definition_or_measurement_approach":"Assessment via full pulmonary function testing including spirometry, lung volumes, diffusion capacity, and arterial/venous blood gases."}
• {"endpoint_text":"- Adverse effects of the program","definition_or_measurement_approach":"Recording and assessment of adverse effects related to the rehabilitation program."}
• {"endpoint_text":"- Adverse events","definition_or_measurement_approach":"Recording and reporting of adverse events per study safety procedures."}
• {"endpoint_text":"- Program adherence","definition_or_measurement_approach":"Assessment of adherence to the rehabilitation program (attendance/compliance measures)."}

Spain

Earliest CTIS Part Ii Submission Date

18-11-2024

Latest Decision Or Authorization Date

27-11-2024

Processing Time Days

9

Number Of Sites

5

Number Of Participants

60

Primary sponsor

Full Name

Fundacio Institut De Recerca De L'Hospital De La Santa Creu I Sant Pau

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain

Third parties

• {"country":"Bulgaria","full_name":"LINDE GAS BULGARIA EOOD","duties_or_roles":"Manufacturer/supplier of investigational product 'Conoxia 100% medicinal gas, cryogenic' (active substance: oxygen).","organisation_type":""}
• {"country":"Spain","full_name":"LINDE GAS ESPANA S.A.U.","duties_or_roles":"Manufacturer/supplier of comparator product 'CONOXIA, gas medicinal comprimido' (active substance: oxygen).","organisation_type":""}