Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00484263
Status:
COMPLETED
Last Update Posted:
2011-06-23
First Post:
2007-06-07
Brief Title:
The Long Term Effect of Inhaled Hypertonic Saline 6 in Patients With Non Cystic Fibrosis Bronchiectasis
Sponsor:
The Alfred
Organization:
The Alfred
Study Overview
Official Title:
The Long Term Effect of Inhaled Hypertonic Saline 6 in Patients With Non-cystic Fibrosis Bronchiectasis
Status:
COMPLETED
Status Verified Date:
2011-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 09 - 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
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 09 - 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None