Skip to main content
OpenTrials
Completed

NCT Number: NCT00484263

The Long Term Effect of Inhaled Hypertonic Saline (6%) in Patients With Non Cystic Fibrosis Bronchiectasis

The purpose of this study is to determine whether the daily inhalation of nebulised hypertonic saline (6%) will decrease the incidence of pulmonary exacerbations and increase the quality of life for people with non cystic fibrosis bronchiectasis.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The Alfred Hospital

Melbourne, Victoria, 3126, Australia

About this study

Bronchiectasis is a disabling, chronic respiratory condition which significantly impacts on the quality of life of patients who present with chronic sputum production and respiratory infections. The occurrence of pulmonary infections is a strong predictor of morbidity and mortality in this group of people so the primary goal of treatment is to prevent infections caused by the presence of sputum in their lungs.

Physiotherapy is a major aspect of their management and focuses on teaching appropriate airways clearance techniques. Traditionally, the physiotherapy management of sputum retention due to bronchiectasis has included the active cycle of breathing technique which has been demonstrated to enhance airways clearance. For some patients, this treatment is not adequate. The use of nebulised hypertonic saline has been used for patients with cystic fibrosis and has been demonstrated to improve sputum removal and lung function.

The aim of this project is to determine the long term effect of the daily inhalation of hypertonic saline on respiratory infections, quality of life, lung function and hospital admissions in patients with non cystic fibrosis bronchiectasis. Hypertonic saline has been shown to be beneficial as a once only treatment in this patient group, but its' long term effects have not been studied.

Participants will be randomised to two groups - those receiving hypertonic saline (6%) and those receiving isotonic saline (0.9%) - and will be blinded to the treatment that they are receiving. They will be given nebuliser equipment and will be instructed how and when to inhale their medication.

Objective measures will be taken by a blinded assessor before the commencement of the project and then at 3 months, 6 months and 12 months post commencement.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • diagnosis of bronchiectasis on high resolution computer tomography
  • at least 2 respiratory exacerbations per year over the past 2 years
  • producing sputum daily
  • in a stable clinical state
  • over 18 years of age.

Exclusion criteria

  • cystic fibrosis
  • Positive response to hypertonic saline challenge - FEV 1 decreased by ≥ 15%
  • FEV 1 ≤ 1L

Treatment and study plan

Hypertonic saline 6% -

Drug

Hypertonic saline (6%) - 5mls twice a day via a nebuliser for 12 months

Primary outcomes

  1. Number of pulmonary exacerbations

    Time frame: One year

Secondary outcomes

  1. - St George Respiratory questionnaire - Leicester Cough Questionnaire - Lung Function Tests

    Time frame: One year

Sponsors and collaborators

Lead sponsor

The Alfred

Other

Registry information

Official study title

The Long Term Effect of Inhaled Hypertonic Saline (6%) in Patients With Non-cystic Fibrosis Bronchiectasis.

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Jun 8, 2007
Registry last updated
Jun 23, 2011

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.

Published trials that share one or more normalized conditions with this study.