S2 What is the clinical effectiveness and cost-effectiveness of nebulised 7% saline in patients with chronic obstructive pulmonary disease (COPD)- (MucAct COPD Trial)

Résumé fourni par la source

This was an open pragmatic UK multi-centre parallel RCT in participants with COPD that have either chronic bronchitis and/or associated bronchiectasis that have self-reported difficulty self-expectorating. Participants were randomised to receive either nebulised 7% saline plus active cycle breathing technique (ACBT) twice daily (intervention arm) or 750 mg carbocisteine plus ACBT twice daily for 1 year (control arm). The Primary objective was to assess whether the intervention arm was superior compared with the controlled arm when comparing the change in COPD Assessment Test (CAT) over 1 y. Secondary objectives: health related quality of life; exacerbations; time to first exacerbation; lung function; health economic benefit; safety. The aim was to recruit 860 participants. Randomisation was on a 1:1 basis and included stratification for current smoking status and COPD severity (GOLD class 1 and 2 versus 3 and 4). Due to difficulty in recruitment post COVID, the funding was stopped after 206 participants completed the study. 104 participants were in the control arm and 102 participants in the intervention arm. The demographics were well matched between groups. There was no significant difference in the improvement of CAT scores at 1 y comparing the control and intervention arms from baseline (control arm n=56, -2.5 (-7.5 to 1.5), intervention arm n=50, -1 (-6 to 3), p=0.37). There was no significant difference in quality-of-life questionnaires, lung function tests, or serious adverse events at 1 y. In the intervention arm there were fewer exacerbations than the control arm (p=0.017) (in the intervention arm 70% had no exacerbations and in the control arm 56% had no exacerbations); hazard ratio was 0.628 (95% CI 0.399–0.988, p= 0.044). There was a trend to fewer upper respiratory tract infections assessed using the WURSS24 questionnaire in the intervention arm (83% no upper respiratory tract infections) compared with the control arm (72%, p=0.053). There was a prolonged time to first exacerbation requiring antibiotic therapy and/or systemic steroids (p=0.044) in the intervention arm. Conclusion Although hypertonic saline compared with carbocisteine treatment led to no significant difference in the CAT questionnaire, there was a prolonged time to first exacerbation and reduced exacerbations.

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