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Sponsored by: |
The Alfred |
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Information provided by: | The Alfred |
ClinicalTrials.gov Identifier: | NCT00484263 |
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.
Condition | Intervention | Phase |
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Bronchiectasis |
Drug: Hypertonic saline 6% - |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment |
Official Title: | The Long Term Effect of Inhaled Hypertonic Saline (6%) in Patients With Non-Cystic Fibrosis Bronchiectasis. |
Estimated Enrollment: | 40 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator |
Drug: Hypertonic saline 6% -
Hypertonic saline (6%) - 5mls twice a day via a nebuliser for 12 months
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Caroline H Nicolson, MPhysio | +613 9076 3450 | c.nicolson@alfred.org.au |
Australia, Victoria | |
The Alfred Hospital | Recruiting |
Melbourne, Victoria, Australia, 3126 | |
Contact: Caroline H Nicolson, MPhysio +613 9076 3450 c.nicolson@alfred.org.au | |
Contact: Anne Holland, PhD +613 9076 3450 a.holland@alfred.org.au | |
Principal Investigator: Caroline H Nicolson, MPhysio | |
Sub-Investigator: Anne Holland, PhD, BAppSc |
Study Chair: | Anne Holland, PhD, BAppSc | The Alfred Hospital |
Principal Investigator: | Caroline H Nicolson, MPhysio | The Alfred Hospital |
Responsible Party: | The Alfred Hospital ( Mrs Caroline Nicolson ) |
Study ID Numbers: | T10716 |
Study First Received: | June 7, 2007 |
Last Updated: | December 31, 2007 |
ClinicalTrials.gov Identifier: | NCT00484263 |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
Respiratory Tract Diseases Fibrosis Bronchiectasis |
Bronchial Diseases |