Back to resultsHypertonic Saline (6%) Versus Isotonic Saline (0.9%) in Bronchiectasis
Primary Purpose
Bronchiectasis
Status
Unknown status
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Hypertonic saline
Isotonic saline
Sponsored by
About this trial
This is an interventional treatment trial for Bronchiectasis focused on measuring Bronchiectasis, Hypertonic saline
Eligibility Criteria
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
Sites / Locations
- Belfast HSCTRecruiting
Outcomes
Primary Outcome Measures
24 hour sputum volume
24 hour volume sputum
Secondary Outcome Measures
Pulmonary Function Testing
Spirometry (FEV1 and FVC) will assess the side effects using HTS.
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.
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.
Patient Reported Outcomes RSSQ
RSSQ: a signs and symptoms questionnaire used in clinical trials in order to diagnose an exacerbation.
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.
Bronchiectasis Qol Questionnaire
Bronchiectasis Qol Questionnaire is a disease specific questionnaire developed to assess disease specific QOL in Bronchiectasis
Full Information
NCT ID
NCT01112410
First Posted
April 27, 2010
Last Updated
April 27, 2010
Sponsor
Belfast Health and Social Care Trust
1. Study Identification
Unique Protocol Identification Number
NCT01112410
Brief Title
Hypertonic Saline (6%) Versus Isotonic Saline (0.9%) in Bronchiectasis
Official Title
A Randomised Double Blind 13 Week Crossover Trial of Hypertonic Saline (6%) Versus Isotonic Saline (0.9%) in Patients With Bronchiectasis.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
August 2010 (Anticipated)
Study Completion Date
August 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Belfast Health and Social Care Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiectasis
Keywords
Bronchiectasis, Hypertonic saline
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Other
Intervention Name(s)
Hypertonic saline
Intervention Description
Hypertonic saline (6%) nebulised twice a day for 4 weeks.
(Randomised crossover trial)
Intervention Type
Other
Intervention Name(s)
Isotonic saline
Intervention Description
Isotonic Saline (0.9%) nebulised twice a day for 4 weeks.
Primary Outcome Measure Information:
Title
24 hour sputum volume
Description
24 hour volume sputum
Time Frame
13 weeks
Secondary Outcome Measure Information:
Title
Pulmonary Function Testing
Description
Spirometry (FEV1 and FVC) will assess the side effects using HTS.
Time Frame
13 weeks
Title
Rheology
Description
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
Title
Adherence
Description
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
Title
Patient Reported Outcomes RSSQ
Description
RSSQ: a signs and symptoms questionnaire used in clinical trials in order to diagnose an exacerbation.
Time Frame
13 weeks
Title
Patient Reported Outcome: Leicester Cough Questionnaire:
Description
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
Title
Bronchiectasis Qol Questionnaire
Description
Bronchiectasis Qol Questionnaire is a disease specific questionnaire developed to assess disease specific QOL in Bronchiectasis
Time Frame
13 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Belfast HSCT
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Judy Bradley, PHD
Phone
+44 28 90329241
Ext
2719
Email
jm.bradley@ulster.ac.uk
12. IPD Sharing Statement
Learn more about this trial
Hypertonic Saline (6%) Versus Isotonic Saline (0.9%) in Bronchiectasis
We'll reach out to this number within 24 hrs