Phase 2 Cystic Fibrosis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults aged 18 or older (and possibly young people aged 12–17 if later study results support expanding the trial to this age group)
• People who are able to give their own consent, or whose legal guardians are able to give consent on their behalf
• People who speak enough German (or have a representative who does) to complete study questionnaires and follow study instructions
• People who have a confirmed diagnosis of cystic fibrosis, shown by at least one of: a sweat chloride test result of 60 or above, two known cystic fibrosis gene changes, or specific test results from nasal or rectal measurements typical of cystic fibrosis
• People whose lung function test (FEV1) shows at least 50% of the expected value for someone their age and size
• People whose lung clearance index (a measure of how well air moves through the lungs) is 7.05 or above at the screening visit
• People who are able to reliably perform the breathing tests required by the study
• People whose blood oxygen level is at least 90% while breathing normal room air at the screening visit
• People whose cystic fibrosis medications have not changed for at least 4 weeks before starting each treatment period
• People whose blood tests show that bone marrow function is within acceptable ranges (confirm with trial site for specific values)
• People whose liver function blood test results are within acceptable limits
• People whose blood clotting results are within acceptable limits
• People who test negative for HIV, Hepatitis B, Hepatitis C, and tuberculosis infection at screening
• Women who could become pregnant must have a negative pregnancy test at screening
• Women who are sexually active must be using an adequate form of contraception, such as hormonal contraception, an intrauterine device, or complete sexual abstinence

Who may not be able to join:

• People who are unlikely or unwilling to follow the study procedures
• People with a known allergy to anakinra or any ingredient in the Kineret® medication used in this trial
• People who have received a live vaccine within 4 weeks before starting the study treatment, or who plan to receive one during the treatment period
• People with kidney failure (based on a specific blood test result being above the normal range)
• People who have a history of tuberculosis, or who have had non-tuberculosis mycobacteria detected from airway samples more than once in the 12 months before starting each treatment period
• People in whom a specific bacteria called Burkholderia cenocepacia has been detected in the 12 months before starting each treatment period
• People colonised with certain antibiotic-resistant bacteria (MRSA or certain resistant Pseudomonas aeruginosa), if the treating doctor considers this to pose an increased risk for that person
• People who have had an acute lung infection flare-up (requiring antibiotics by any method) within 14 days before screening or before starting each treatment period
• People showing signs of any other active infection within 14 days before screening or before starting each treatment period
• People currently receiving immunosuppressive treatment due to an organ transplant, or a rheumatic or autoimmune condition, or who have been treated with anakinra in the 3 months before the study begins
• People who have taken part in another interventional clinical trial within 30 days before screening
• People currently taking oral corticosteroids (steroid tablets or liquid)
• People who currently require supplemental oxygen
• People currently being treated with etanercept
• People who have previously had a lung transplant
• Women who are pregnant or breastfeeding
• People with a known sensitivity to hypertonic saline (a saltwater solution used to help produce a sputum sample in this trial)

Important: Always verify eligibility with the trial site directly before applying.