bronchiectasis MedDRA version: 21.0 Level: PT Classification code 10006445 Term: Bronchiectasis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: Hypertonic saline solution 7%
Pharmaceutical Form: Nebulisation solution
INN or Proposed INN: CN 826917
Current Sponsor code: ETGOL PROTOCOL
Other descriptive name: SODIUM CHLORIDE SOLUTIO
Sponsors
University Hospital Dr Josep Trueta
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. - To assess possible side effects - To assess adherence to the different regimes - 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Change from baseline in the 24h sputum volume in millilitres and sputum weight during the intervention and 24 hours later over the 12-month treatment period. - Change in cough assessed with the Leicester Cough Questionnaire from V2 over the 12-month treatment period. - Number of exacerbations and the time to the first exacerbation over the 12-month treatment period. - Change in sputum purulence assessed by the sputum colour chart, mucus properties, and microbiology from V2 to V7. -Change in quality of life (assessed with Bronchiectasis health questionnaire and Saint George Respiratory questionnaire) from V2 over the 12-month treatment period -Change from V2 in post-bronchodilator FEV1 over the 12-month treatment period in ml - Treatment adherence assessed through vial counting, Morisky-Green test, the diary card. - Adverse events assessed by symptoms reported, vital sign measurement (including blood pressure and arterial oxygen saturation), physical examination, Borg scale at the end of interventions at V2, V3, V5, V7, and pulmonary function tests at V2. - Change from V7 to V8 in the 24h sputum volume, colour and weight, quality of life and FEV1;Timepoint(s) of evaluation of this end point: 12 MONTHS | — |
Countries
Spain
Contacts
Public ContactCristina Martinez
University Hospital Dr Josep Trueta
Outcome results
None listed