A Phase 2 interventional study of Hypertonic saline and Isotonic saline in Bronchiectasis, sponsored by Belfast Health and Social Care Trust. Status unknown at 1 site in United Kingdom. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2010-04-28.
Sponsored by Belfast Health and Social Care Trust · Phase 2, Interventional, and Treatment
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.
368 studies on the registry are indexed under Bronchiectasis; 104 are open to participants now.
This study's planned enrollment of 20 is below the median of 60 across 233 interventional studies indexed under Bronchiectasis.
Browse Bronchiectasis studies →Belfast Health and Social Care Trust is the lead sponsor of 43 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Hypertonic saline (6%) nebulised twice a day for 4 weeks. (Randomised crossover trial)
Isotonic Saline (0.9%) nebulised twice a day for 4 weeks.
24 hour sputum volume
24 hour volume sputum
Time frame: 13 weeks
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
Time frame: 13 weeks
This study is status unknown, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.
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Belfast Health and Social Care Trust