Benefits of saline solution inhalation prior to respiratory physiotherapy, in patients with bronchiectasis

Phase 1

• Conditions: bronchiectasis; MedDRA version: 21.0Level: PTClassification code 10006445Term: BronchiectasisSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2020-001026-62-ES
• Lead Sponsor: niversity Hospital Dr Josep Trueta

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-06
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

Men and woman,= 18 years old with bronchiectasis confirmed by high resolution computed tomography, with no exacerbations in the previous month, chronic purulent sputum (=10ml daily expectoration), at least one exacerbation in the previous year, FEV1 =30% after bronchodilation and sign the informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 25
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 32

Exclusion Criteria

=85 years old,asthma, allergic bronchopulmonary aspergillosis or CF; current smokers or a smoking history of =20 p-y; following mucoactive treatment in the month previous; contraindications to perform ELTGOL, spirometry or to attend visits; practising pulmonary rehabilitation in the previous 6 months, change of treatment the previous month; uncontrolled hypertension

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the effect of the combination of once-daily 7% hypertonic saline and twice-daily ELTGOL technique in mucus clearance in patients with bronchiectasis compared both to once-daily isotonic saline and twice-daily ELTGOL technique and to twice-daily ELTGOL technique on its own;Secondary Objective: - To evaluate the effects of the three treatment regimes on the impact of cough, exacerbations, mucus properties, quality of life, sputum cultures and pulmonary function in these patients.<br>- To assess possible side effects <br>- To assess adherence to the different regimes<br>- To assess whether the effects are sustained one month after the treatment is ended;Primary end point(s): the change in the sputum weight in grams during intervention from baseline to V7;Timepoint(s) of evaluation of this end point: 12 MONTHS