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

Phase 2

• Conditions: Bronchiectasis

• Registration Number: NCT01112410
• Lead Sponsor: Belfast Health and Social Care Trust

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 Description

Not available

Study Timeline

• Status Verified: 2010-01
• Study Start: 2010-01
• Study First Submitted: 2010-04-27
• Study First Submitted QC: 2010-04-27
• Last Update Submitted: 2010-04-27
• Study First Posted: 2010-04-28
• Last Update Posted: 2010-04-28
• Primary Completion: 2010-08
• Study Completion: 2010-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Non CF Bronchiectasis
• 18-80 years
• FEV1 less than 90%
• Chronic sputum production
• Clinical stable

Read More

Exclusion Criteria

• Intolerance to HTS
• Use of HTSaline or antibiotics 14 days prior to study
• Clinically unstable
• Smokers

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
24 hour sputum volume	13 weeks	24 hour volume sputum

Secondary Outcome Measures

Name	Time	Method
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
Pulmonary Function Testing	13 weeks	Spirometry (FEV1 and FVC) will assess the side effects using HTS.
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.
Patient Reported Outcomes RSSQ	13 weeks	RSSQ: a signs and symptoms questionnaire used in clinical trials in order to diagnose an exacerbation.

Trial Locations

Locations (1)

Belfast HSCT; 🇬🇧 Belfast, Northern Ireland, United Kingdom