Hypertonic Saline (6%) Versus Isotonic Saline (0.9%) in Bronchiectasis
Recruitment status was Recruiting
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 Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Randomised Double Blind 13 Week Crossover Trial of Hypertonic Saline (6%) Versus Isotonic Saline (0.9%) in Patients With Bronchiectasis.|
- 24 hour sputum volume [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]24 hour volume sputum
- Pulmonary Function Testing [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]Spirometry (FEV1 and FVC) will assess the side effects using HTS.
- Rheology [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]Bronchiectasis Qol Questionnaire is a disease specific questionnaire developed to assess disease specific QOL in Bronchiectasis
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||August 2010|
|Estimated Primary Completion Date:||August 2010 (Final data collection date for primary outcome measure)|
Other: Hypertonic saline
Hypertonic saline (6%) nebulised twice a day for 4 weeks.
(Randomised crossover trial)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01112410
|Belfast, Northern Ireland, United Kingdom, BT9 7AB|
|Contact: Judy Bradley, PHD +44 28 90329241 ext 2719 firstname.lastname@example.org|