TABLE 1

Summary of randomised controlled trials found not to be published (2008–2018)

NCT numberTrial titleYear#PhasePrimary end-point group(s)Secondary end-point group(s)
NCT00775138A study to determine the safety and tolerability of arikace versus placebo in patients who have bronchiectasis2008–20092Lung function, otherLung function, microbiology, HRQoL
NCT01677403A study to access safety and efficacy of nebulized tobramycin in patients with bronchiectasis2012–20144MicrobiologySputum, lung function, HRQoL
NCT01684683The effect of theophylline in the treatment of bronchiectasis2012–20144HRQoLExacerbations, sputum, HRQoL, lung function, microbiology, biomarkers, other
NCT01580748Phase 2, single group, open clinical trial to evaluate the efficacy and safety of roflumilast in symptomatic bronchiectasis patients2012–20132HRQoLLung function, biomarkers
NCT01818544Safety and efficacy of oral BAY85–8501 in patients with non-CF (cystic fibrosis) bronchiectasis2013–20142OtherLung function, HRQoL, sputum, biomarkers
NCT01769898The role of theophylline plus low-dose formoterol-budesonide in treatment of bronchiectasis2013–20144HRQoLExacerbations, sputum, lung function, biomarkers
NCT02088216Effect of long-term, high-dose N-acetylcysteine on exacerbations of bronchiectaisis (BENE)2014–20164ExacerbationsSputum, exacerbations, lung function, HRQoL, other
NCT02104245Phase 3 study with ciprofloxacin dispersion for inhalation in non-CF bronchiectasis (ORBIT-4)2014–20163ExacerbationsNo information
NCT01515007Phase 3 study with ciprofloxacin dispersion for inhalation in non-CF bronchiectasis (ORBIT-3)2014–20163ExacerbationsNo information
NCT02546297Comparisons of inhaled LAMA or ICS+LABA for COPD with bronchiectasis2015–20174ExacerbationsLung function, HRQoL, other
NCT02507843Vitamin D as an adjunctive treatment in patients with non-cystic fibrosis bronchiectasis (VIDB)2015–20174ExacerbationsExacerbations, HRQoL, other

All trials were registered at clinicaltrials.gov. Primary end-points (n=12): exacerbations (n=5), health-related quality of life (HRQoL) (n=3), microbiology (n=1), other (n=2) and lung function (n=1). Secondary end-points (n=34): lung function (n=8), HRQoL (n=7), sputum (n=5), exacerbations (n=4), biomarkers (n=4), other (n=4) and microbiology (n=2). “Other” end-points include FACED score, vital signs and adverse events. LAMA: long-acting muscarinic antagonists; ICS: inhaled corticosteroid; LABA: long-acting β-agonists; COPD: chronic obstructive pulmonary disease. #: it is recommended that trials are reported within 1 year of completion, and so trials are listed here if completed earlier than November 2017.