POTASSIUM CHLORIDE PH. EUR.; SODIUM CHLORIDE PH. EUR. for Bronchiectasis

Inclusion criteria

• {"criterion_text":"- Men and woman ≥ 18 years old\n- Bronchiectasis confirmed by high resolution computed tomography\n- no exacerbations in the previous month\n- chronic purulent sputum ( ≥10ml daily expectoration)\n- at least one exacerbation in the previous year\n- FEV1 ≥30% after bronchodilation\n- sign the informed consent"}

Exclusion criteria

• {"criterion_text":"- patients > 85 years old\n- asthma, allergic bronchopulmonary aspergillosis or cystic fibrosis\n- current smokers or a smoking history of ≥20 pack/year\n- following mucoactive treatment in the previous month\n- contraindications to perform ELTGOL, spirometry or to attend visits\n- pulmonary rehabilitation in the previous 6 months\n- change of treatment the previous month\n- uncontrolled hypertension"}

Primary endpoints

• {"endpoint_text":"- change in the sputum weight in grams during intervention from baseline to V7","definition_or_measurement_approach":"Change in sputum weight measured in grams during the intervention from baseline to visit V7."}

Secondary endpoints

• {"endpoint_text":"- Change from baseline in the 24h sputum volume in millilitres and sputum weight (defined as the sputum volume during the intervention and 24 hours later) over the 12-month treatment period.","definition_or_measurement_approach":"24-hour sputum volume in mL and sputum weight measured during the intervention and 24 hours later; change from baseline over 12-month treatment period."}
• {"endpoint_text":"- Change in cough assessed with the Leicester Cough Questionnaire26 from V2 over the 12-month treatment period","definition_or_measurement_approach":"Change from baseline (V2) in Leicester Cough Questionnaire score over 12 months."}
• {"endpoint_text":"- Number of exacerbations and the time to the first exacerbation over the 12-month treatment period","definition_or_measurement_approach":"Count of exacerbations and time-to-first-exacerbation assessed during 12-month treatment period."}
• {"endpoint_text":"- Change in sputum purulence assessed by the sputum colour chart, mucus properties, and microbiology from V2 to V7.","definition_or_measurement_approach":"Change from V2 to V7 in sputum purulence via sputum colour chart, mucus properties assessments, and sputum microbiology."}
• {"endpoint_text":"- Change in quality of life (assessed with Bronchiectasis health questionnaire and Saint George Respiratory questionnaire) from V2 over the 12-month treatment period","definition_or_measurement_approach":"Change from V2 in QoL measured by Bronchiectasis Health Questionnaire and St. George's Respiratory Questionnaire over 12 months."}
• {"endpoint_text":"- Change from V2 in post-bronchodilator FEV1 over the 12-month treatment period in ml","definition_or_measurement_approach":"Change from V2 in post-bronchodilator FEV1 (ml) measured over 12 months."}
• {"endpoint_text":"- Treatment adherence assessed through vial counting, Morisky-Green test, the diary card.","definition_or_measurement_approach":"Adherence assessed by vial counts, Morisky-Green questionnaire, and participant diary card."}
• {"endpoint_text":"- Adverse events assessed by symptoms reported, vital sign measurement (including blood pressure and arterial oxygen saturation), physical examination, Borg scale at the end of interventions at V2, V3, V5, V7, and pulmonary function tests at V2.","definition_or_measurement_approach":"Safety assessed via reported symptoms, vital signs (including BP and SpO2), physical exam, Borg scale at end of interventions at specified visits, and pulmonary function tests at V2."}
• {"endpoint_text":"- Change from V7 to V8 in the 24h sputum volume, colour and weight, quality of life and FEV1","definition_or_measurement_approach":"Change between V7 and V8 in 24h sputum volume, colour and weight, QoL measures, and FEV1."}

Spain

Earliest CTIS Part Ii Submission Date

31-10-2024

Latest Decision Or Authorization Date

11-07-2025

Processing Time Days

253

Number Of Sites

2

Number Of Participants

57

Primary sponsor

Full Name

Hospital Universitari De Girona Doctor Josep Trueta

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Spain