Study 14 of 34 for search of: "Bronchiectasis"
Previous Study Return to Search Results Next Study

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
The Long Term Effect of Inhaled Hypertonic Saline (6%) in Patients With Non Cystic Fibrosis Bronchiectasis
This study is currently recruiting participants.
Verified by The Alfred, December 2007
Sponsored by: The Alfred
Information provided by: The Alfred
ClinicalTrials.gov Identifier: NCT00484263
  Purpose

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
Bronchiectasis
Drug: Hypertonic saline 6% -
Phase III

U.S. FDA Resources
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.

Further study details as provided by The Alfred:

Primary Outcome Measures:
  • Number of pulmonary exacerbations [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • - St George Respiratory questionnaire - Leicester Cough Questionnaire - Lung Function Tests [ Time Frame: One year ] [ Designated as safety issue: No ]

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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00484263

Contacts
Contact: Caroline H Nicolson, MPhysio +613 9076 3450 c.nicolson@alfred.org.au

Locations
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            
Sponsors and Collaborators
The Alfred
Investigators
Study Chair: Anne Holland, PhD, BAppSc The Alfred Hospital
Principal Investigator: Caroline H Nicolson, MPhysio The Alfred Hospital
  More Information

Publications:
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

Study placed in the following topic categories:
Respiratory Tract Diseases
Fibrosis
Bronchiectasis

Additional relevant MeSH terms:
Bronchial Diseases

ClinicalTrials.gov processed this record on January 16, 2009