CARE‐CF‐1.

Methods	Multicentre, double‐blind, placebo‐controlled RCT. 6‐arm.
Participants	89 adults with CF experiencing acute exacerbations. Age, mean (SD): 29.8 years (9.6). Gender split: 48% female. FEV1 % predicted, mean (SD): 43.3% (18.3) predicted.
Interventions	Oral cysteamine (Lynovex®) as an adjunct to conventional treatment over 14 days. Intervention arm 1: 450 mg 4x daily. Intervention arm 2: 150 mg 3x daily. Intervention arm 3: 450 mg 2x daily. Intervention arm 4: 300 mg 3x daily. Intervention arm 5: 450 mg 3x daily. Intervention arm 6: placebo.
Outcomes	Change from baseline in sputum gram‐negative bacterial load. Changes in patient‐reported outcome measures from baseline: assessment using the CF respiratory symptom diary; chronic respiratory infection symptom score (CFRSD‐CRSS); CFQ‐R; and Jarad and Sequeiros Symptom Score Questionnaire. Blood leukocyte count. Change from baseline in sputum neutrophil elastase and IL‐8 levels. Change in FEV1, weight and BMI. Adverse events and serious adverse events.
Notes	The trial looks at the safety and efficacy of oral cysteamine in addition to finding the most important patient‐reported outcomes. Awaiting full publication of efficacy trial.