AIR-NET- Testing anti-inflammatories for the treatment of bronchiectasis

A randomised, open-label, multifactorial, multicentre, platform trial using a range of repurposed anti-inflammatory treatments to improve outcomes in patients with bronchiectasis not due to cystic fibrosis, within the EMBARC international clinical research network.

Registry ID
ISRCTN17596258
Source registry
ISRCTN
Status
Recruiting
Phase
PHASE2
Study type
INTERVENTIONAL
Sponsor
University of Dundee
Enrollment
168
Start date
2024-11-18
Completion date
2027-02-28
Last update
2026-08-17

Conditions

Summary

Bronchiectasis

Detailed description

Participants will be randomised using the online Tayside Randomisation System (TRuST) to one of the trial arms: Arm 1: Usual care Arm 2: Disulfiram 200 mg, two tablets taken orally, once daily Arm 3: Dipyridamole 200 mg, one capsule taken orally, twice daily Arm 4: Doxycycline 100 mg, one capsule taken orally, once daily Trial treatment will be for 28 days, with a 28 day follow up period.

Interventions

Inclusion criteria

1. ≥18 years 2. Able to provide informed consent. 3. Capable of complying with all trial procedures and of completing the trial, in the opinion of the investigator. 4. Bronchiectasis, confirmed by computed tomography (CT), showing bronchiectasis in 1 or more lobes. 5. Normally produces sputum daily. 6. Able to provide a sputum sample at the screening visit or between screening and randomisation. 7. Active neutrophilic inflammation at screening/baseline indicated by a positive NEATstik (Neutrophil Elastase Airways Test) result.

Exclusion criteria

1. Enrolled previously in the trial 3 times. 2. Respiratory infection or bronchiectasis exacerbation 4 weeks prior to screening and/or between screening and randomisation 3. Antibiotic or corticosteroid 4 weeks prior to screening and/or between screening and randomisation 4. Active allergic bronchopulmonary aspergillosis (defined by International Society for Human and Animal Mycology criteria) on steroids and/or anti-fungals, 5. Nontuberculous mycobacterial infection on antibiotic therapy 6. Immunodeficiency on immunoglobulin replacement 7. A primary diagnosis of COPD or asthma (a secondary diagnosis of COPD or asthma is permitted) 8. Cystic fibrosis 9. Active malignancy except non-melanoma skin cancer 10. Currently taking brensocatib 11. Use of any investigational drugs within five times of the elimination half-life after the last dose or within 30 days, whichever is longer. Current enrolment in non-interventional, observational studies will be allowed 12. Currently pregnant or breast-feeding 13. Women of childbearing age and not practicing an acceptable method of birth control 14. Additional exclusion criteria for individual treatment arms are described in the protocol

Locations

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