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

Bronchiectasis Clinical Trial

Official title:

A Randomised Double Blind 13 Week Crossover Trial of Hypertonic Saline (6%) Versus Isotonic Saline (0.9%) in Patients With Bronchiectasis.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01112410
• Other study ID #: 09023JB-OPMS
• Status: Recruiting
• Phase: Phase 2
• First received: April 27, 2010
• Last updated: April 27, 2010
• Start date: January 2010
• Est. completion date: August 2010

Study information

• Verified date: January 2010
• Source: Belfast Health and Social Care Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: Northern Ireland: Office Reserach Ethics Committee Northern Ireland
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchiectasis

Intervention

Other:
• Hypertonic saline
Hypertonic saline (6%) nebulised twice a day for 4 weeks. (Randomised crossover trial)
• Isotonic saline
Isotonic Saline (0.9%) nebulised twice a day for 4 weeks.

Locations

Country	Name	City	State
United Kingdom	Belfast HSCT	Belfast	Northern Ireland

Sponsors (1)

Lead Sponsor	Collaborator
Belfast Health and Social Care Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24 hour sputum volume	24 hour volume sputum	13 weeks	No
Secondary	Pulmonary Function Testing	Spirometry (FEV1 and FVC) will assess the side effects using HTS.	13 weeks	Yes
Secondary	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.	13 weeks	No
Secondary	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.	13 weeks	No
Secondary	Patient Reported Outcomes RSSQ	RSSQ: a signs and symptoms questionnaire used in clinical trials in order to diagnose an exacerbation.	13 weeks	No
Secondary	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.	13 weeks	No
Secondary	Bronchiectasis Qol Questionnaire	Bronchiectasis Qol Questionnaire is a disease specific questionnaire developed to assess disease specific QOL in Bronchiectasis	13 weeks	No