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

Study Overview
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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.

Official Title
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A Randomised Double Blind 13 Week Crossover Trial of Hypertonic Saline (6%) Versus Isotonic Saline (0.9%) in Patients With Bronchiectasis.

Conditions
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Bronchiectasis

Intervention / Treatment
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* Other: Hypertonic saline
* Other: Isotonic saline


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Hypertonic saline|Hypertonic saline (6%) nebulised twice a day for 4 weeks. (Randomised crossover trial)|
|Other: Isotonic saline|Isotonic Saline (0.9%) nebulised twice a day for 4 weeks.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 hour sputum volume | 24 hour volume sputum | 13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary Function Testing | Spirometry (FEV1 and FVC) will assess the side effects using HTS. | 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. | 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. | 13 weeks | 
| Patient Reported Outcomes RSSQ | RSSQ: a signs and symptoms questionnaire used in clinical trials in order to diagnose an exacerbation. | 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. | 13 weeks | 
| Bronchiectasis Qol Questionnaire | Bronchiectasis Qol Questionnaire is a disease specific questionnaire developed to assess disease specific QOL in Bronchiectasis | 13 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bronchiectasis, Hypertonic saline