The Long Term Effect of Inhaled Hypertonic Saline (6%) in... | NCT00484263

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

NCT00484263

Sponsor

The Alfred

Status

Completed

Last Update Posted

Jun 23, 2011Estimated

Enrollment

40Actual

Phase

Phase 3

Conditions

Bronchiectasis

Interventions

Hypertonic saline 6% -

Countries

Australia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2007

Primary Completion Date

Oct 2009Actual

Completion Date

Oct 2009Actual

First Submitted Date

Jun 7, 2007

First Submission Date that Met QC Criteria

Jun 7, 2007

First Posted Date

Jun 8, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 22, 2011

Last Update Posted Date

Jun 23, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator		Drug: Hypertonic saline 6% -

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Hypertonic saline 6% -	Drug	Hypertonic saline (6%) - 5mls twice a day via a nebuliser for 12 months	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of pulmonary exacerbations		One year

Secondary Outcomes

Measure	Description	Time Frame
- St George Respiratory questionnaire - Leicester Cough Questionnaire - Lung Function Tests		One year

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anne Holland, PhD, BAppSc	The Alfred	Study Chair
Caroline H Nicolson, MPhysio	The Alfred	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Alfred Hospital		Melbourne	Victoria	3126	Australia

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16421364	Background	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.
15672845

ID	Term
D001982	Bronchial Diseases
D012140	Respiratory Tract Diseases