Bronchiectasis
Conditions
Keywords
Bronchiectasis, Hypertonic saline
Brief summary
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.
Interventions
OTHERHypertonic saline
Hypertonic saline (6%) nebulised twice a day for 4 weeks. (Randomised crossover trial)
OTHERIsotonic saline
Isotonic Saline (0.9%) nebulised twice a day for 4 weeks.
Sponsors
Belfast Health and Social Care Trust
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 24 hour sputum volume | 13 weeks | 24 hour volume sputum |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rheology | 13 weeks | 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. |
| Adherence | 13 weeks | 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. |
| Pulmonary Function Testing | 13 weeks | Spirometry (FEV1 and FVC) will assess the side effects using HTS. |
| Patient Reported Outcome: Leicester Cough Questionnaire: | 13 weeks | 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. |
| Bronchiectasis Qol Questionnaire | 13 weeks | Bronchiectasis Qol Questionnaire is a disease specific questionnaire developed to assess disease specific QOL in Bronchiectasis |
| Patient Reported Outcomes RSSQ | 13 weeks | RSSQ: a signs and symptoms questionnaire used in clinical trials in order to diagnose an exacerbation. |
Countries
United Kingdom
Outcome results
None listed