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. 2019 Nov 10;20(22):5618. doi: 10.3390/ijms20225618

Table 1.

Clinical trials evaluating the efficacy and safety of antibiotics in idiopathic pulmonary fibrosis.

Study Name Study Design Study Duration Status Primary Outcome Estimated Enrolment/Inclusion Criteria Trial Number
Azithromycin for the Treatment of Cough in Idiopathic Pulmonary Fibrosis—A Clinical Trial Single centre, prospective, double blind, randomized, 2 treatments, 2 period cross-overPlacebo versus Azithromycin 500 mg/d three times weekly Two 12-week treatment periods separated by a 4-week drug-free washout period Completed Subjective response to treatment (1.3 unit reduction of cough as measured with Leicester Cough Score) 25 patientsAge ≥ 18 years, IPF diagnosis, symptoms of cough NCT02173145
Study of Clinical Efficacy of Antimicrobial Therapy Strategy Using Pragmatic Design in Idiopathic Pulmonary Fibrosis (cleanUp-IPF) Phase III, randomized, un-blinded, multi-centreTrimethoprim/Sulfamethoxazole (T/S) 160/800 mg twice daily OR doxycicline 100 mg/d if T/S is not indicated 42 months Recruiting Time to first non-elective respiratory hospitalization or all-cause mortality 500 patientsAge ≥ 40 years, IPF diagnosis NCT02759120
The Efficacy and Mechanism Evaluation of Treating Idiopathic Pulmonary Fibrosis with the Addition of Co-Trimoxazole (EME-TIPAC) Phase III, double blind, parallel group, randomized, placebo controlled multicentreCo-trimoxazole 960 mg twice daily versus placebo Between 12 and 42 (median 27) months Recruiting Time to death (all causes), lung transplant or the first non-elective hospital admission 330 patientsAge > 40 years, MRC dyspnoea score > 1, on stable treatment regimen for at least 4 weeks *, IPF diagnosis EUDRACT 2014-004058-32

* Oral prednisolone up to 10 mg/d, anti-oxidant therapy, Pirfenidone, Nintedanib or other lensed medication for IPF.