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Details

Autor(en) / Beteiligte
Titel
Heterogeneity of treatment response in bronchiectasis clinical trials
Ist Teil von
  • The European respiratory journal, 2022-05, Vol.59 (5), p.2100777
Ort / Verlag
England
Erscheinungsjahr
2022
Quelle
Free E-Journal (出版社公開部分のみ)
Beschreibungen/Notizen
  • Recent randomised clinical trials in bronchiectasis have failed to reach their primary end-points, suggesting a need to reassess how we measure treatment response. Exacerbations, quality of life (QoL) and lung function are the most common end-points evaluated in bronchiectasis clinical trials. We aimed to determine the relationship between responses in terms of reduced exacerbations, improved symptoms and lung function in bronchiectasis. We evaluated treatment response in three randomised clinical trials that evaluated mucoactive therapy (inhaled mannitol), an oral anti-inflammatory/antibiotic (azithromycin) and an inhaled antibiotic (aztreonam). Treatment response was defined by an absence of exacerbations during follow-up, an improvement of QoL above the minimum clinically important difference and an improvement in forced expiratory volume in 1 s (FEV ) of ≥100 mL from baseline. Cumulatively the three trials included 984 patients. Changes in FEV , QoL and exacerbations were heterogeneous in all trials analysed. Improvements in QoL were not correlated to changes in FEV in the azithromycin and aztreonam trials (r= -0.17, p=0.1 and r=0.04, p=0.4, respectively) and weakly correlated in the mannitol trial (r=0.22, p<0.0001). An important placebo effect was observed in all trials, especially regarding improvements in QoL. Clinical meaningful lung function improvements were rare across all trials evaluated, suggesting that FEV is not a responsive measure in bronchiectasis. Improvements in lung function, symptoms and exacerbation frequency are dissociated in bronchiectasis. FEV is poorly responsive and poorly correlated with other key outcome measures. Clinical parameters are poorly predictive of treatment response, suggesting the need to develop biomarkers to identify responders.
Sprache
Englisch
Identifikatoren
ISSN: 0903-1936
eISSN: 1399-3003
DOI: 10.1183/13993003.00777-2021
Titel-ID: cdi_proquest_miscellaneous_2584438388

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