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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-01

Study Completion Date

2027-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Bronchiectasis Adult

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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ELTGOL group

Control group. Patients will do twice-daily ELTGOL technique

Group Type OTHER

ELTGOL

Intervention Type OTHER

Patients from control group will perform the ELTGOL technique twice-daily

ELTGOL + isotonic saline solution (0,9%)

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

Group Type PLACEBO_COMPARATOR

Isotonic saline

Intervention Type DRUG

Patients from placebo group will inhale isotonic saline solution 5 minutes before performing the morning ELTGOL technique

ELTGOL

Intervention Type OTHER

Patients from control group will perform the ELTGOL technique twice-daily

ELTGOL + hypertonic saline solution (7%)

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

Group Type EXPERIMENTAL

Hypertonic saline

Intervention Type OTHER

Patients from intervention group will inhale hypertonic saline solution 5 minutes before performing the morning ELTGOL technique

ELTGOL

Intervention Type OTHER

Patients from control group will perform the ELTGOL technique twice-daily

Interventions

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Hypertonic saline

Patients from intervention group will inhale hypertonic saline solution 5 minutes before performing the morning ELTGOL technique

Intervention Type OTHER

Isotonic saline

Patients from placebo group will inhale isotonic saline solution 5 minutes before performing the morning ELTGOL technique

Intervention Type DRUG

ELTGOL

Patients from control group will perform the ELTGOL technique twice-daily

Intervention Type OTHER

Other Intervention Names

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Physiologic saline

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No