Long-term randomized controlled trial to evaluate the efficacy of low expiration with the open glottis in the lateral posture (ELTGOL) in patients with bronchiectasis (BC)

Abstract

No placebo controlled clinical trials evaluating airway clearance techniques have been performed in BC. We evaluate short and long-term efficacy of ELTGOL in BC in a randomized control trial with placebo (Clinical Trial Registration NCT01578681). Non-cystic fibrosis BC adult patients in stable state with >10ml sputum/day not practising regular chest physiotherapy were randomized to perform ELTGOL or a placebo exercise twice daily. Patients were assessed at 7 visits (V) over one year. Primary endpoint: sputum volume during the procedure at V2 and 24-h post treatment. Secondary endpoints: sputum volume during the procedure at V7 and 24-h post treatment; Leicester Cough Questionnaire (LCQ), Saint George's Respiratory Questionnaire (SGRQ).

Results: 44 patients were randomized (22 ELTGOL group and 22 placebo group; mean age 63.04±13.48 and 67.72±9.08). Sputum volume during the procedure at V2 and 24-h post treatment were higher in the ELTGOL group (12.27±11.92ml vs. 0ml and 47.75±31.6ml vs. 12.04±9.86ml, p<0.001). At V7 sputum volume during the procedure and 24-h post treatment were higher in the ELTGOL group (11.07±5.60ml vs. 0ml and 45.71±26.30ml vs. 13.43±7.46ml, p<0.001). The ELTGOL group showed a significant improvement in the SGRQ (p<0.001) andthe LCQ (p<0.002).

Conclusions: The ELTGOL technique is effective in airway clearance both in the short and long term, improves quality of life and reduces the impact of daily cough in non-cystic fibrosis BC adult patients.

Funding: SEPAR, SOCAP, CFC, ACMG, Fiss PI12/01551.