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

Belfast Health and Social Care Trust20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Bronchiectasis

Interventions

Hypertonic salineOTHER

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

Isotonic salineOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Belfast HSCT

Belfast, Northern Ireland, United Kingdom

RECRUITING

Outcomes

Primary Outcomes

24 hour sputum volume

24 hour volume sputum

Time frame: 13 weeks

Secondary Outcomes

Pulmonary Function Testing

Spirometry (FEV1 and FVC) will assess the side effects using HTS.

Time frame: 13 weeks

Rheology

Rheology is the measurement of the viscosity and elasticity of sputum (viscoelasticity) and also the thread forming ability of mucus (spinnibility). Rheology will assess the extent to which HTS effect the viscosity of secretions and rehydrates secretions by drawing water into the mucus via osmosis.

Time frame: 13 weeks

Adherence

All used and unused vials of the study drug shall be counted. The researcher will review the returned vials (used and unused) along with the patient diary cards, which record information regarding airway clearance and administration of study drug.

Time frame: 13 weeks

Patient Reported Outcomes RSSQ

RSSQ: a signs and symptoms questionnaire used in clinical trials in order to diagnose an exacerbation.

Time frame: 13 weeks

Patient Reported Outcome: Leicester Cough Questionnaire:

Leicester Cough Questionnaire: a valid and reliable health status measure for adults with chronic cough Quality of Life Questionnaire Bronchiectasis (QOL-B), a tool used to evaluate quality of life in patients with bronchiectasis.

Time frame: 13 weeks

Bronchiectasis Qol Questionnaire

Bronchiectasis Qol Questionnaire is a disease specific questionnaire developed to assess disease specific QOL in Bronchiectasis

Data from ClinicalTrials.gov

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