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NCT Number: NCT06443658

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

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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Key information

Conditions

Bronchiectasis Adult

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

University Hospital of Girona Dr. Josep Trueta

Girona, Spain

Location status: Recruiting

Location contact

Gerard Muñoz, PhD PT

CONTACT

Montse Vendrell, PhD MD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hypertonic saline

Other

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

Isotonic saline

Drug

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

Other names: Physiologic saline

ELTGOL

Other

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

Primary outcomes

  1. The change in the sputum weight in grams during intervention

    Time frame: Baseline and 12 months later

    Sputum weight will be measured with a precision balance after the intervention

Secondary outcomes

  1. Change in sputum properties 1

    Time frame: Changes between Month 1 and Month 12

    Sputum properties will be evaluated analyzing viscosity (mPa/s) and elasticity (Pa)

  2. Change in sputum properties 2

    Time frame: Changes between Month 1 and Month 12

    Sputum properties will be evaluated analyzing solids in sputum

  3. Change from baseline in the 24hours sputum volume in milliliters

    Time frame: Over the 12-month treatment period.

    Sputum volume will be measured with a calibrated container

  4. Change from baseline in the 24hours sputum weight

    Time frame: Over the 12-month treatment period.

    Sputum weight will be measured with a precision balance

  5. Change in cough

    Time frame: Over the 12-month treatment period.

    Assessed with the Leicester Cough Questionnaire (LCQ). Score form 3 to 21 (3 better and 21 worse cough)

  6. Number of exacerbations

    Time frame: Over the 12-month treatment period.

    Based on clinical history

  7. Time to the first exacerbation

    Time frame: Over the 12-month treatment period.

    Based on clinical history

  8. Change in quality of life

    Time frame: Over the 12-month treatment period

    Assessed with Bronchiectasis health questionnaire (BHQ). BHQ score from 0-100 (0 best and 100 worse quality of life)

  9. Change in post-bronchodilator ( forced expiratory volume at one second) FEV1

    Time frame: Over the 12-month treatment period in ml

    Assessed with a forced spirometry

  10. Treatment adherence 1

    Time frame: Over the 12-month treatment period

    Assessed through vial counting.

  11. Treatment adherence 2

    Time frame: Over the 12-month treatment period

    Assessed through the diary card.

  12. Treatment adherence 3

    Time frame: Over the 12-month treatment period

    Assessed through Morisky-Green test. Score from 0 to 4 (0 best and 4 worse adherence)

  13. Adverse events 1

    Time frame: Over the 12-month treatment period

    Assessed by Borg scale at the end of interventions. Score 0-10 (0 best and 10 worse breathlessness)

  14. Adverse events 2

    Time frame: Over the 12-month treatment period

    Assessed by oxygen desaturation

  15. Adverse events 3

    Time frame: Over the 12-month treatment period

    Assessed by Visual Analogue Scale (VAS) scale (pain assessment)

  16. Change in sputum weight during intervention

    Time frame: Between Month 12 and Month 13

    Sputum weight will be measured with a precision balance after the intervention

  17. Change in sputum volume in 24h sputum volume

    Time frame: Between Month 12 and Month 13

    Sputum volume will be measured with a calibrated container

  18. Change in cough

    Time frame: Between Month 12 and Month 13

    Assessed with the Leicester Cough Questionnaire (LCQ). Score form 3 to 21 (3 better and 21 worse cough)

  19. Change in post-bronchodilator FEV1

    Time frame: Between Month 12 and Month 13

    Assessed with a forced spirometry

  20. Change in quality of life

    Time frame: Between Month 12 and Month 13

    Assessed with Bronchiectasis health questionnaire (BHQ). BHQ score from 0-100 (0 best and 100 worse quality of life)

Study contacts

Contact information is provided by the study sponsor or research team.

Gerard Muñoz, PhD PT

CONTACT

[email protected]

0034-972940294

Neus Puigdevall, PT

CONTACT

[email protected]

0034-972940294

Sponsors and collaborators

Lead sponsor

Institut d'Investigació Biomèdica de Girona Dr. Josep Trueta

Other

Collaborators

  • Germans Trias i Pujol Hospital
  • University Hospital of Girona Dr. Josep Trueta

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 5, 2024
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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