Phase 3 Cystic Fibrosis Trial, Terminated

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:

• People who are able and willing to give their written consent after having the study fully explained to them
• People aged 18 years or older, of any gender
• People who have been diagnosed with non-cystic fibrosis bronchiectasis (a lung condition causing widened, damaged airways) confirmed by a CT or high-resolution CT scan, and this is their main condition being treated
• People who have had at least 2 chest flare-ups related to their bronchiectasis requiring antibiotic tablets or inhaled antibiotics, or at least 1 flare-up requiring antibiotic drip, in the 12 months before the first study visit — and no flare-ups between the first and second study visits
• People who have a recorded history of a lung infection caused by a bacteria called Pseudomonas aeruginosa
• People who have been medically stable and have not needed any changes to their lung treatment for at least 30 days before the first study visit
• People whose lung function test (a breathing test measuring how much air can be blown out) shows a result of at least 25% of the expected normal value
• People whose mucus sample (sputum test) taken at or around the first study visit shows a positive result for Pseudomonas aeruginosa bacteria

Who may not be able to join:

• People whose bronchiectasis is caused by cystic fibrosis
• People with a condition called hypogammaglobulinaemia (low immune proteins in the blood) who need treatment with immunoglobulin, unless the trial doctor considers their immune system to be fully functioning
• People with myasthenia gravis (a muscle weakness disorder) or porphyria (a rare metabolic disorder)
• People with serious heart or blood pressure conditions, such as severe uncontrolled high blood pressure, heart disease, or irregular heartbeat, or any other condition the trial doctor believes could affect safety
• People who had major surgery in the 3 months before the first study visit, or who have major surgery planned during the study
• People currently being treated for a fungal lung condition called allergic bronchopulmonary aspergillosis (ABPA)
• People who have coughed up a large amount of blood (300 mL or more, or enough to need a blood transfusion) in the 4 weeks before the first study visit, or between the first and second study visits
• People with breathing failure severe enough that the trial doctor considers it a safety risk or likely to affect study results
• People with an active cancer, except for certain non-spreading skin cancers (basal cell carcinoma or squamous cell carcinoma without spread)
• People who have taken immune-suppressing medications (such as azathioprine, cyclosporine, tacrolimus, sirolimus, mycophenolate, or rituximab) or anti-inflammatory biological medications (such as anti-IL-6 or anti-TNF products) in the year before the first study visit
• People with a known history of HIV infection
• People currently being treated for tuberculosis or a related lung infection called non-tuberculous mycobacterial (NTM) lung disease
• People who are known or suspected to be allergic to, or unable to tolerate, a medication called colistimethate sodium (given by drip or inhaler) or similar antibiotic medicines called polymyxins, including those who have had airway sensitivity reactions to inhaled colistimethate sodium
• People who started long-term use (30 days or more) of prednisone at a dose greater than 15 mg per day (or an equivalent steroid dose) within six months of the first study visit
• People who started a new ongoing course of certain antibiotics called macrolides (such as azithromycin, erythromycin, or clarithromycin) within 30 days of the first study visit, or between the first and second study visits
• People who used any antibiotic specifically targeting Pseudomonas aeruginosa (given by drip, injection, tablet, or inhaler — except stable-dose macrolides) within 30 days before the first study visit, or between the first and second study visits
• People who are pregnant, breastfeeding, planning to become pregnant in the next two years, or who could become pregnant but are unwilling to use a reliable form of contraception from at least one month before being assigned to a treatment group and throughout the study
• People with significant abnormal results on physical checks, blood tests, kidney function tests (specifically, creatinine levels at or above twice the upper limit of normal), heart tracing (ECG), or other clinical tests that the trial doctor considers a safety concern
• People who have taken part in another clinical intervention trial within 30 days before the first study visit
• People whom the trial doctor considers unsuitable for inclusion for any reason

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