The Long Term Effect of Inhaled Hypertonic Saline (6%) in Patients With Non Cystic Fibrosis Bronchiectasis
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Dec 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2007
CompletedFirst Posted
Study publicly available on registry
June 8, 2007
CompletedStudy Start
First participant enrolled
December 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedJune 23, 2011
June 1, 2011
1.8 years
June 7, 2007
June 22, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Number of pulmonary exacerbations
One year
Secondary Outcomes (1)
- St George Respiratory questionnaire - Leicester Cough Questionnaire - Lung Function Tests
One year
Study Arms (1)
1
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- cystic fibrosis
- Positive response to hypertonic saline challenge - FEV 1 decreased by ≥ 15%
- FEV 1 ≤ 1L
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The Alfredlead
Study Sites (1)
The Alfred Hospital
Melbourne, Victoria, 3126, Australia
Related Publications (3)
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.
PMID: 16421364BACKGROUNDKellett 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.
PMID: 15672845BACKGROUNDNicolson 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.
PMID: 22349069DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Anne Holland, PhD, BAppSc
The Alfred
- PRINCIPAL INVESTIGATOR
Caroline H Nicolson, MPhysio
The Alfred
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 7, 2007
First Posted
June 8, 2007
Study Start
December 1, 2007
Primary Completion
October 1, 2009
Study Completion
October 1, 2009
Last Updated
June 23, 2011
Record last verified: 2011-06