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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00484263
Recruitment Status : Completed
First Posted : June 8, 2007
Last Update Posted : June 23, 2011
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Bronchiectasis Drug: Hypertonic saline 6% - Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Long Term Effect of Inhaled Hypertonic Saline (6%) in Patients With Non-cystic Fibrosis Bronchiectasis.
Study Start Date : December 2007
Actual Primary Completion Date : October 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: 1 Drug: Hypertonic saline 6% -
Hypertonic saline (6%) - 5mls twice a day via a nebuliser for 12 months

Primary Outcome Measures :
  1. Number of pulmonary exacerbations [ Time Frame: One year ]

Secondary Outcome Measures :
  1. - St George Respiratory questionnaire - Leicester Cough Questionnaire - Lung Function Tests [ Time Frame: One year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00484263

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Australia, Victoria
The Alfred Hospital
Melbourne, Victoria, Australia, 3126
Sponsors and Collaborators
The Alfred
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Study Chair: Anne Holland, PhD, BAppSc The Alfred
Principal Investigator: Caroline H Nicolson, MPhysio The Alfred
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Mrs Caroline Nicolson, The Alfred Hospital Identifier: NCT00484263    
Other Study ID Numbers: T10716
First Posted: June 8, 2007    Key Record Dates
Last Update Posted: June 23, 2011
Last Verified: June 2011
Additional relevant MeSH terms:
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Bronchial Diseases
Respiratory Tract Diseases