Hypertonic Saline (6%) Versus Isotonic Saline (0.9%) in Bronchiectasis

NCT ID: NCT01112410

Last Updated: 2010-04-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-31

Study Completion Date

2010-08-31

Brief Summary

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The investigators hypothesise that nebulised hypertonic saline (6%) will increase the volume of sputum expectorated over a 24 hour period compared to nebulised isotonic saline (0.9%) in patients with mild to severe stable bronchiectasis.

Detailed Description

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Conditions

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Bronchiectasis

Keywords

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Bronchiectasis Hypertonic saline

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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Hypertonic saline

Hypertonic saline (6%) nebulised twice a day for 4 weeks.

(Randomised crossover trial)

Intervention Type OTHER

Isotonic saline

Isotonic Saline (0.9%) nebulised twice a day for 4 weeks.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Non CF Bronchiectasis
* 18-80 years
* FEV1 less than 90%
* Chronic sputum production
* Clinical stable

Exclusion Criteria

* Intolerance to HTS
* Use of HTSaline or antibiotics 14 days prior to study
* Clinically unstable
* Smokers
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Belfast Health and Social Care Trust

OTHER

Sponsor Role lead

Responsible Party

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Belfast Health and Social Care Trust

Locations

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Belfast HSCT

Belfast, Northern Ireland, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Facility Contacts

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Judy Bradley, PHD

Role: primary

Other Identifiers

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09023JB-OPMS

Identifier Type: -

Identifier Source: org_study_id