Hypertonic Saline (6%) Versus Isotonic Saline (0.9%) in Bronchiectasis
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|ClinicalTrials.gov Identifier: NCT01112410|
Recruitment Status : Unknown
Verified January 2010 by Belfast Health and Social Care Trust.
Recruitment status was: Recruiting
First Posted : April 28, 2010
Last Update Posted : April 28, 2010
|Condition or disease||Intervention/treatment||Phase|
|Bronchiectasis||Other: Hypertonic saline Other: Isotonic saline||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomised Double Blind 13 Week Crossover Trial of Hypertonic Saline (6%) Versus Isotonic Saline (0.9%) in Patients With Bronchiectasis.|
|Study Start Date :||January 2010|
|Estimated Primary Completion Date :||August 2010|
|Estimated Study Completion Date :||August 2010|
- Other: Hypertonic saline
Hypertonic saline (6%) nebulised twice a day for 4 weeks.
(Randomised crossover trial)
- Other: Isotonic saline
Isotonic Saline (0.9%) nebulised twice a day for 4 weeks.
- 24 hour sputum volume [ Time Frame: 13 weeks ]24 hour volume sputum
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01112410
|Belfast, Northern Ireland, United Kingdom, BT9 7AB|
|Contact: Judy Bradley, PHD +44 28 90329241 ext 2719 firstname.lastname@example.org|