Benefits of Inhalation of Hypertonic Saline Solution Prior to Physiotherapy ELTGOL Technique in Bronchiectasis

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Status and phase: Enrolling; Phase 3

Conditions: Bronchiectasis Adult

Treatments: Drug: Isotonic saline; Other: Hypertonic saline; Other: ELTGOL

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT06443658

FISHT2021

Details and patient eligibility

About

Bronchiectasis is a chronic bronchial disease in which the usual capacity to remove secretions does not function correctly, causing mucus retention that leads to chronic infection. As with all infections, the use of antibiotics and puss removal are essential treatment elements. Physiotherapeutic techniques are used to assist in the removal of secretions, although these are time-consuming practices that need to be much better studied and which patients often do not continue practicing diligently. A physiotherapeutic technique called (Slow prolonged expiration in lateral decubitus) ELTGOL has been shown to be somewhat effective but as the mucus is viscous in this disorder, it can be difficult to get it to move. It is thought that saline solution inhalations may reduce mucus viscosity and could help to ease expectoration, facilitating the removal of the mucus by the physiotherapeutic technique. This project aims to test this hypothesis, which if true could represent an advance in the treatment of this severely debilitating disease.

Full description

Bronchiectasis is a prevalent chronic infectious disease with impaired mucociliary clearance. The persistence of high bacterial loads in the bronchi is associated with airway and systemic inflammation. Management is based on treatment of bronchial infection and on removal of secretions by airway clearance techniques (ACTs) although no therapy has been approved due to low quality of evidence. Inhalation of hypertonic saline (HS) could be useful in facilitate mucus removal especially if it is administer prior an effective ACT.Our hypothesis is that the long-term combination of HS and the ELTGOL technique will facilitate secretion removal in bronchiectasis and this will be associated with changes in mucus composition and better control of the disease.

Study design: A 12-month parallel-group, multicentre, double-blind randomised-controlled trial. Patients will be randomly assigned to receiving HS, isotonic saline (IS) or no inhalation before practicing ELTGOL technique.

The main objective is to evaluate the effect of the combination of once-daily inhaled HS and twice daily ELTGOL technique in mucus clearance in bronchiectasis. Secondary aims: to determine its effect on mucus properties, the impact of cough,exacerbations, quality of life, microbiology and pulmonary function; to evaluate adverse effects and adherence.

Study population: adult patients with non-cystic fibrosis bronchiectasis in stable state with chronic mucopurulent or purulent sputum.

Enrollment: 57 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adult patients with bronchiectasis confirmed by high resolution computed tomography
• No exacerbations in the previous month
• Chronic mucopurulent and purulent sputum
• ≥10ml daily expectoration
• At least one exacerbation in the previous year
• (Forced expiratory volume the 1st second) FEV1 ≥30% after bronchodilation
• Sign the informed consent

Exclusion criteria

• Current smokers or a smoking history of ≥20 p-y
• Asthma, allergic bronchopulmonary aspergillosis or Cystic Fibrosis
• Pregnant or lactating women
• Following mucoactive treatment in the previous month
• Inability to perform ELTGOL, spirometry or to attend visits
• Practicing pulmonary rehabilitation in the previous 6 months
• Change of treatment the previous month
• Uncontrolled hypertension

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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57 participants in 3 patient groups, including a placebo group

ELTGOL group

Other group

Description:

Control group. Patients will do twice-daily ELTGOL technique

Treatment:

Other: ELTGOL

ELTGOL + isotonic saline solution (0,9%)

Placebo Comparator group

Description:

Placebo group. Patients will do twice-daily ELTGOL technique and will receive 5ml of 0.9% saline before performing the ELTGOL technique in the morning

Treatment:

Other: ELTGOL

Drug: Isotonic saline

ELTGOL + hypertonic saline solution (7%)

Experimental group

Description:

Experimental group. Patients will do twice-daily ELTGOL technique and will receive 5ml of 7% saline before performing the ELTGOL technique in the morning

Treatment:

Other: ELTGOL

Other: Hypertonic saline