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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Belfast Health and Social Care Trust.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Belfast Health and Social Care Trust
ClinicalTrials.gov Identifier:
NCT01112410
First received: April 27, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

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 Intervention Phase
Bronchiectasis
Other: Hypertonic saline
Other: Isotonic saline
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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.

Further study details as provided by Belfast Health and Social Care Trust:

Primary Outcome Measures:
  • 24 hour sputum volume [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
    24 hour volume sputum


Secondary Outcome Measures:
  • Pulmonary Function Testing [ Time Frame: 13 weeks ] [ Designated as safety issue: Yes ]
    Spirometry (FEV1 and FVC) will assess the side effects using HTS.

  • Rheology [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    Bronchiectasis Qol Questionnaire is a disease specific questionnaire developed to assess disease specific QOL in Bronchiectasis


Estimated Enrollment: 20
Study Start Date: January 2010
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Dr Judy Bradley, Belfast Health and Social Care Trust
ClinicalTrials.gov Identifier: NCT01112410     History of Changes
Other Study ID Numbers: 09023JB-OPMS
Study First Received: April 27, 2010
Last Updated: April 27, 2010
Health Authority: Northern Ireland: Office Reserach Ethics Committee Northern Ireland

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

Additional relevant MeSH terms:
Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 19, 2014