Efficacy of Temporary Positive Expiratory Pressure (TPEP) in patients with lung diseases and chronic mucus hypersecretion. The UNIKO project: a multicentre randomised controlled trial.

Objective: To evaluate whether Temporary Positive Expiratory Pressure provides benefit in patients with lung diseases and chronic hypersecretion.Design: Single blind multicentre randomised trial.Setting: 5 Italian rehabilitation centres.Participants: 98 patients with Chronic Obstructive Pulmonary Disease and/or Chronic Bronchitis (n=78), or Bronchiectasis (n=20), with a Peak Cough Expiratory Flow >150 l/min and sputum production >30 mL/day, randomly included in two treatment groups. Interventions: For 10 consecutive days, Active group performed twice a day 20-min cycles of Manually Assisted Breathing Techniques in sequence with the addition of 15-min of Temporary Positive Expiratory Pressure, while Control group was treated by Manually Assisted Breathing Techniques alone.Measures: Within and between group changes of arterial oxygenation index, lung volumes and respiratory muscles strength were recorded at enrolment, after 3, and 10 treatment sessions. Pre-to-post treatment change of sputum volume and bronchial encumbrance (Δ-VAS), sputum density and purulence, were compared daily within the study period. Results: No significant changes were recorded for the oxygenation index, while dynamic lung volumes and respiratory muscle strength significantly (p <0.05) improved in Active group. The group comparison analysis of the pre-to-post change showed that Inspiratory Capacity was significantly higher in Active than in Control group (+19.5% and +2.2%, p=0.044) at day 10. A greater improvement in Δ-VAS was recorded in Active group at day 3 and 8. Conclusions: These preliminary data suggest that Temporary Positive Expiratory Pressure improves lung volumes and speeds up the improvement of bronchial encumbrance in patients with lung diseases and hypersecretion.