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

Phase 3

Completed

• Conditions: Bronchiectasis
• Interventions: Drug: Hypertonic saline 6% -

• Registration Number: NCT00484263
• Lead Sponsor: The Alfred

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2007-06-07
• Study First Submitted QC: 2007-06-07
• Study First Posted: 2007-06-08
• Study Start: 2007-12
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-22
• Last Update Posted: 2011-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Hypertonic saline 6% -	-

Primary Outcome Measures

Name	Time	Method
Number of pulmonary exacerbations	One year

Secondary Outcome Measures

Name	Time	Method
- St George Respiratory questionnaire - Leicester Cough Questionnaire - Lung Function Tests	One year

Trial Locations

Locations (1)

The Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia