BronchiectasisPhase 2NCT01112410
Hypertonic Saline (6%) Versus Isotonic Saline (0.9%) in Bronchiectasis
A Phase 2 study testing Hypertonic saline and Isotonic saline in people with Bronchiectasis, run by Belfast Health and Social Care Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Bronchiectasis
- What is being tested?
- Hypertonic saline and Isotonic saline
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2010to Aug 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non CF Bronchiectasis
- 18-80 years
- FEV1 less than 90%
- Chronic sputum production
- Clinical stable
Who cannot join
- Intolerance to HTS
- Use of HTSaline or antibiotics 14 days prior to study
- Clinically unstable
- Smokers
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Belfast HSCT
Belfast, Northern Ireland, BT9 7AB
Judy Bradley, PHD, +44 28 90329241 ext. 2719, jm.bradley@ulster.ac.uk
About this study
Official title: A Randomised Double Blind 13 Week Crossover Trial of Hypertonic Saline (6%) Versus Isotonic Saline (0.9%) in Patients With Bronchiectasis.
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.
- Conditions
- Bronchiectasis
- Being tested
- Hypertonic saline, Isotonic saline
- Keywords
- Bronchiectasis, Hypertonic saline
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
24 hour sputum volume
24 hour volume sputum
Measured: 13 weeks
Secondary outcomes (6)
Pulmonary Function Testing
Spirometry (FEV1 and FVC) will assess the side effects using HTS.
Measured: 13 weeks
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.
Measured: 13 weeks
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.
Measured: 13 weeks
Patient Reported Outcomes RSSQ
RSSQ: a signs and symptoms questionnaire used in clinical trials in order to diagnose an exacerbation.
Measured: 13 weeks
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.
Measured: 13 weeks
Bronchiectasis Qol Questionnaire
Bronchiectasis Qol Questionnaire is a disease specific questionnaire developed to assess disease specific QOL in Bronchiectasis
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2010 (estimated)
- Study startJan 2010
- Primary completionAug 2010 (estimated)
- Study completionAug 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Belfast Health and Social Care Trust
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01112410
- Sponsor's protocol ID
- 09023JB-OPMS
- Status last verified
- Jan 2010
- First submitted
- 27 Apr 2010
- Last updated
- 28 Apr 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Double Blind 13 Week Crossover Trial of Hypertonic Saline (6%) Versus Isotonic Saline (0.9%) in Patients With Bronchiectasis.
- ClinicalTrials.gov ID
- NCT01112410
- Acronym / sponsor ID
- 09023JB-OPMS
- Conditions
- Bronchiectasis
- Keywords
- Bronchiectasis, Hypertonic saline
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Belfast Health and Social Care TrustUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Aug 2010 (estimated)
- Study completion
- Aug 2010 (estimated)
- First posted
- 28 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Non CF Bronchiectasis
- 18-80 years
- FEV1 less than 90%
- Chronic sputum production
- Clinical stable
Key exclusion criteria (4 listed)
- Intolerance to HTS
- Use of HTSaline or antibiotics 14 days prior to study
- Clinically unstable
- Smokers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypertonic salineHypertonic saline (6%) nebulised twice a day for 4 weeks. (Randomised crossover trial) | Other | – |
| Isotonic salineIsotonic Saline (0.9%) nebulised twice a day for 4 weeks. | Other | – |
Primary outcome
24 hour sputum volume
Time frame: 13 weeks
24 hour volume sputum
6 secondary outcomes
Pulmonary Function Testing
Time frame: 13 weeks
Rheology
Time frame: 13 weeks
Adherence
Time frame: 13 weeks
Patient Reported Outcomes RSSQ
Time frame: 13 weeks
Patient Reported Outcome: Leicester Cough Questionnaire:
Time frame: 13 weeks
Bronchiectasis Qol Questionnaire
Time frame: 13 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hypertonic saline and Isotonic saline in people with Bronchiectasis, run by Belfast Health and Social Care Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24 hour sputum volume (time frame: 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2010.