NCT01112410

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 27, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 28, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

April 28, 2010

Status Verified

January 1, 2010

Enrollment Period

7 months

First QC Date

April 27, 2010

Last Update Submit

April 27, 2010

Conditions

Bronchiectasis

Keywords

BronchiectasisHypertonic saline

Outcome Measures

Primary Outcomes (1)

  • 24 hour sputum volume

    24 hour volume sputum

    13 weeks

Secondary Outcomes (6)

  • Pulmonary Function Testing

    13 weeks

  • Rheology

    13 weeks

  • Adherence

    13 weeks

  • Patient Reported Outcomes RSSQ

    13 weeks

  • Patient Reported Outcome: Leicester Cough Questionnaire:

    13 weeks

  • +1 more secondary outcomes

Interventions

Hypertonic salineOTHER

Hypertonic saline (6%) nebulised twice a day for 4 weeks. (Randomised crossover trial)

Isotonic salineOTHER

Isotonic Saline (0.9%) nebulised twice a day for 4 weeks.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Non CF Bronchiectasis
  • years
  • FEV1 less than 90%
  • Chronic sputum production
  • Clinical stable

You may not qualify if:

  • Intolerance to HTS
  • Use of HTSaline or antibiotics 14 days prior to study
  • Clinically unstable
  • Smokers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Belfast HSCT

Belfast, Northern Ireland, BT9 7AB, United Kingdom

RECRUITING

MeSH Terms

Conditions

Bronchiectasis

Interventions

Saline Solution, HypertonicSodium Chloride

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Hypertonic SolutionsSolutionsPharmaceutical PreparationsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 27, 2010

First Posted

April 28, 2010

Study Start

January 1, 2010

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

April 28, 2010

Record last verified: 2010-01

Locations

GB(1)