None listed
Conditions
Brief summary
In this RCT study we are investigating if colchicine, an old but safe medication, can help speed up recovery from wet cough flare-ups in children with bronchiectasis. Colchicine is an anti-inflammatory medication which is used in children in Australia for other conditions and has been shown to be safe. Colchicine could likely work through its effects on the neutrophil cells that can cause inflammation. This inflammation in the airways is an important part of the lung disease in bronchiectasis. In adults, inhibition of neutrophils (via other new drugs) has reduced exacerbations and increased time between flare-ups. This study is the first to look at the role of colchicine in the treatment of bronchiectasis flare-ups in either adults or children.
Interventions
Oral colchicine tablets 0.5 mg once daily for 14 days in all children
Adherence to trial medication will be monitored via medication logs and return of medication packaging at end of day 14.
In addition to the study medications, the treatment group will receive concurrent 14 days of antibiotics as standard practice for treatment of RE. This is typically oral amoxicillin-clavulanic acid the current recommended antibiotic therapy for REs in children with bronchiectasis. This will be given at a
Oral colchicine tablets 0.5 mg once daily for 14 days in all children Adherence to trial medication will be monitored via medication logs and return of medication packaging at end of day 14. In addition to the study medications, the treatment group will receive concurrent 14 days of antibiotics as standard practice for treatment of RE. This is typically oral amoxicillin-clavulanic acid the current recommended antibiotic therapy for REs in children with bronchiectasis. This will be given at a dose of 22.5mg/kg/dose twice daily (liquid or tablets). This will be the antibiotic of choice for the RCT and it is expected will be used in the majority of children. If the patient is allergic to amoxicillin-clavulanic acid, bactrim (sulfamethoxazole and trimethoprim) is the suggested alternative. If the patient as grown pseudomonas on sputum or BAL standard anti-pseudomonal therapies (oral and/or inhaled) will be used. If a patient is to be admitted for intravenous antibiotic therapy for the exacerbation standard clinical care antibiotics will be used. (typically ceftriaxone). All patients will be invited to provide blood, saliva and lower airway samples (e.g. spontaneous or induced sputum or bronchoalveolar lavage if being collected) at baseline and randomisation. If the participant cannot provide sputum (e.g. due to age) or does not consent to blood, saliva sor sputum samples this does not proclude them from participating in the RCT.
Sponsors
Queensland University of Technology
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
2 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
Children (aged 2 to < 18 years) with (a) computed tomography (CT) proven bronchiectasis; (b) at least 2 respiratory exacerbations (RE) in the last 12-months or hospitalised for an RE in the last 12-months; and (c) plan to remain at one of the study sites >12-months
Exclusion criteria
(a) advanced renal disease (creatinine clearance <30mL/min) or any liver disease (b) haematological conditions associated with neutropaenia (c) taking clarithromycin, azoles or anti-rejection therapy (cyclosporine, tacrolimus) (d) known adverse events from colchicine (e) unable to be followed-up (f) previously enrolled (g) participating in another current RCT (h) participant is pregnant
Outcome results
None listed