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

Primary Purpose

Bronchiectasis

Status
Completed
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
Hypertonic saline 6% -
Sponsored by
The Alfred
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiectasis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Alfred Hospital

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Number of pulmonary exacerbations

Secondary Outcome Measures

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

Full Information

First Posted
June 7, 2007
Last Updated
June 22, 2011
Sponsor
The Alfred
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1. Study Identification

Unique Protocol Identification Number
NCT00484263
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
The Alfred

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiectasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Hypertonic saline 6% -
Intervention Description
Hypertonic saline (6%) - 5mls twice a day via a nebuliser for 12 months
Primary Outcome Measure Information:
Title
Number of pulmonary exacerbations
Time Frame
One year
Secondary Outcome Measure Information:
Title
- St George Respiratory questionnaire - Leicester Cough Questionnaire - Lung Function Tests
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Holland, PhD, BAppSc
Organizational Affiliation
The Alfred
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Caroline H Nicolson, MPhysio
Organizational Affiliation
The Alfred
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3126
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
16421364
Citation
Elkins MR, Robinson M, Rose BR, Harbour C, Moriarty CP, Marks GB, Belousova EG, Xuan W, Bye PT; National Hypertonic Saline in Cystic Fibrosis (NHSCF) Study Group. A controlled trial of long-term inhaled hypertonic saline in patients with cystic fibrosis. N Engl J Med. 2006 Jan 19;354(3):229-40. doi: 10.1056/NEJMoa043900.
Results Reference
background
PubMed Identifier
15672845
Citation
Kellett F, Redfern J, Niven RM. Evaluation of nebulised hypertonic saline (7%) as an adjunct to physiotherapy in patients with stable bronchiectasis. Respir Med. 2005 Jan;99(1):27-31. doi: 10.1016/j.rmed.2004.05.006.
Results Reference
background
PubMed Identifier
22349069
Citation
Nicolson CH, Stirling RG, Borg BM, Button BM, Wilson JW, Holland AE. The long term effect of inhaled hypertonic saline 6% in non-cystic fibrosis bronchiectasis. Respir Med. 2012 May;106(5):661-7. doi: 10.1016/j.rmed.2011.12.021. Epub 2012 Feb 19.
Results Reference
derived

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

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