Brief Title
The Long Term Effect of Inhaled Hypertonic Saline (6%) in Patients With Non Cystic Fibrosis Bronchiectasis
Official Title
The Long Term Effect of Inhaled Hypertonic Saline (6%) in Patients With Non-cystic Fibrosis Bronchiectasis.
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 Phase
Phase 3
Study Type
Interventional
Primary Outcome
Number of pulmonary exacerbations
Secondary Outcome
- St George Respiratory questionnaire - Leicester Cough Questionnaire - Lung Function Tests
Condition
Bronchiectasis
Intervention
Hypertonic saline 6% -
Study Arms / Comparison Groups
1
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
40
Start Date
December 2007
Completion Date
October 2009
Primary Completion Date
October 2009
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Anne Holland, PhD, BAppSc, ,
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT00484263
Organization ID
T10716
Study Sponsor
The Alfred
Study Sponsor
Anne Holland, PhD, BAppSc, Study Chair, The Alfred
Verification Date
June 2011