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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
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Bronchiectasis Other: Hypertonic saline Other: Isotonic saline Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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.
Study Start Date : January 2010
Estimated Primary Completion Date : August 2010
Estimated Study Completion Date : August 2010

Intervention Details:
    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.


Primary Outcome Measures :
  1. 24 hour sputum volume [ Time Frame: 13 weeks ]
    24 hour volume sputum


Secondary Outcome Measures :
  1. Pulmonary Function Testing [ Time Frame: 13 weeks ]
    Spirometry (FEV1 and FVC) will assess the side effects using HTS.

  2. 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.

  3. 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.

  4. Patient Reported Outcomes RSSQ [ Time Frame: 13 weeks ]
    RSSQ: a signs and symptoms questionnaire used in clinical trials in order to diagnose an exacerbation.

  5. 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.


  6. Bronchiectasis Qol Questionnaire [ Time Frame: 13 weeks ]
    Bronchiectasis Qol Questionnaire is a disease specific questionnaire developed to assess disease specific QOL in Bronchiectasis



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
United Kingdom
Belfast HSCT Recruiting
Belfast, Northern Ireland, United Kingdom, BT9 7AB
Contact: Judy Bradley, PHD    +44 28 90329241 ext 2719    jm.bradley@ulster.ac.uk   
Sponsors and Collaborators
Belfast Health and Social Care Trust

Responsible Party: Dr Judy Bradley, Belfast Health and Social Care Trust
ClinicalTrials.gov Identifier: NCT01112410     History of Changes
Other Study ID Numbers: 09023JB-OPMS
First Posted: April 28, 2010    Key Record Dates
Last Update Posted: April 28, 2010
Last Verified: January 2010

Keywords provided by Belfast Health and Social Care Trust:
Bronchiectasis
Hypertonic saline

Additional relevant MeSH terms:
Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases