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Study on the Effects of 7% Hypertonic Saline Inhalation and ELTGOL Physiotherapy for Patients with Bronchiectasis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment for bronchiectasis, a lung condition where the airways become widened, leading to a build-up of mucus that can cause infections. The treatment being tested involves the inhalation of a 7% hypertonic saline solution, which is a saltwater solution that is more concentrated than normal body fluids. This solution is inhaled before performing a specific type of physiotherapy called ELTGOL, which stands for "Expiration with the Glottis Open in the Lateral position." This physiotherapy technique helps clear mucus from the lungs.

The purpose of the study is to evaluate how effective this combination of inhaling the hypertonic saline solution once a day and performing the ELTGOL technique twice a day is in helping patients clear mucus from their lungs. The study will compare this treatment to two other approaches: inhaling a less concentrated saltwater solution, known as isotonic saline, once a day along with the ELTGOL technique twice a day, and performing the ELTGOL technique on its own twice a day.

Participants in the study will follow one of these treatment plans over a period of 12 months. Throughout the study, changes in the amount and characteristics of mucus, the frequency of lung infections, and the overall quality of life will be monitored. The study aims to provide insights into the best approach for managing mucus clearance in patients with bronchiectasis, potentially improving their respiratory health and quality of life.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on criteria such as age, confirmed diagnosis of bronchiectasis, and other health conditions.

    Informed consent is required to participate in the study.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to establish baseline measurements. This includes evaluating sputum weight and volume, cough severity, and quality of life.

    Pulmonary function tests are performed to measure lung capacity and function.

  3. Step 3

    Treatment phase

    The treatment involves daily inhalation of a 7% hypertonic saline solution using the inhalation route.

    The inhalation is followed by the ELTGOL physiotherapy technique, performed twice daily.

    The treatment aims to improve mucus clearance in patients with bronchiectasis.

  4. Step 4

    Ongoing assessments

    Regular assessments are conducted to monitor changes in sputum weight and volume, cough severity, and quality of life.

    Adverse events are monitored through symptoms reported, vital sign measurements, and physical examinations.

  5. Step 5

    Final evaluation

    At the end of the treatment period, a final evaluation is conducted to assess the overall effectiveness of the treatment.

    This includes measuring changes in sputum characteristics, lung function, and quality of life.

Who can join the trial?

7 criteria

  • Men and women who are **18 years old** or older.
  • Have **bronchiectasis**, which is a lung condition, confirmed by a special type of scan called **high resolution computed tomography**.
  • No worsening of symptoms, known as **exacerbations**, in the past month.
  • Produce **chronic purulent sputum**, which means having a persistent cough with thick mucus, with at least **10ml of mucus** produced daily.
  • Have had at least one **exacerbation** in the past year.
  • Have a **FEV1** of 30% or more after using a medicine that helps open the airways. **FEV1** is a measure of how much air you can forcefully exhale in one second.
  • Agree to participate by signing the **informed consent**, which is a document explaining the study and confirming your willingness to join.

Who cannot join the trial?

4 criteria

  • Patients who have a different lung condition other than bronchiectasis. Bronchiectasis is a condition where the airways in the lungs become widened and can lead to mucus build-up.
  • Patients who are not within the specified age range for the study. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population. This means people who might need special protection or care, such as those with certain disabilities or conditions.
  • Patients who do not meet the specific health requirements set by the study. These requirements ensure the safety and effectiveness of the study for participants.
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Investigated drugs

  • 7% Hypertonic Saline Solution

    is a saltwater solution with a higher concentration of salt than normal body fluids. In this trial, it is inhaled once daily to help clear mucus from the lungs of patients with bronchiectasis. The goal is to see if it improves mucus clearance when used before a specific type of physiotherapy.

  • ELTGOL Technique

    is a type of physiotherapy used twice daily in this trial. It involves specific breathing exercises designed to help clear mucus from the lungs. The trial aims to determine the effectiveness of this technique both on its own and in combination with the inhalation of hypertonic saline.

What is already known about the treatment

Hypertonic Saline Solution – This medication is administered through inhalation, typically using a nebulizer, to help clear mucus from the lungs. It is currently being studied in clinical trials for its effectiveness in treating bronchiectasis, a condition characterized by chronic lung infections and mucus buildup. The main therapeutic indication is to improve mucus clearance in patients with this condition. At the molecular level, hypertonic saline works by drawing water into the airways, thinning the mucus, and making it easier to expel. It is classified as an expectorant, which is a type of medication that helps clear mucus from the respiratory tract.

Investigated diseases

Bronchiectasis – Bronchiectasis is a chronic lung condition where the airways become widened and scarred, leading to a build-up of mucus. This can cause frequent lung infections and persistent coughing. Over time, the airways lose their ability to clear out mucus effectively, resulting in further damage and inflammation. Patients may experience symptoms such as breathlessness, wheezing, and fatigue. The condition can vary in severity, with some individuals experiencing mild symptoms and others having more severe respiratory issues. Regular monitoring and management are essential to help control symptoms and prevent complications.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-511677-29-01Protocol codeELTGOLEstimated enrolment57 patientsSponsorHospital Universitari De Girona Doctor Josep Trueta

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