Clinical Trial: Hypertonic Saline (6%) Versus Isotonic Saline (0.9%) in Bronchiectasis
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: A Randomised Double Blind 13 Week Crossover Trial of Hypertonic Saline (6%) Versus Isotonic Saline (0.9%) in Patients With Bronchiectasis.
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.
Detailed Summary:
Sponsor: Belfast Health and Social Care Trust
Current Primary Outcome: 24 hour sputum volume [ Time Frame: 13 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Pulmonary Function Testing [ Time Frame: 13 weeks ]Spirometry (FEV1 and FVC) will assess the side effects using HTS.
- Rheology [ Time Frame: 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 [ Time Frame: 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.
- Patient Reported Outcomes RSSQ [ Time Frame: 13 weeks ]RSSQ: a signs and symptoms questionnaire used in clinical trials in order to diagnose an exacerbation.
- Patient Reported Outcome: Leicester Cough Questionnaire: [ Time Frame: 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 [ Time Frame: 13 weeks ]Bronchiectasis Qol Questionnaire is a disease specific questionnaire developed to assess disease specific QOL in Bronchiectasis
Original Secondary Outcome: Same as current
Information By: Belfast Health and Social Care Trust
Dates:
Date Received: April 27, 2010
Date Started: January 2010
Date Completion: August 2010
Last Updated: April 27, 2010
Last Verified: January 2010