WheezePhase 2TWICSNCT01868932
Treating Wheezing in Children With Hypertonic Saline (TWICS)
A Phase 2 study testing hypertonic saline and saline in people with Wheeze, run by Dr. Michael Flavin.
Trial summary
Hypothesis: substitution of nebulized 3% NaCl (HS) for the standard normal saline (NS) used in bronchodilator therapy for acute viral wheezing in all children under age 6 years will provide superior symptom relief leading to decreased admission rates from the Emergency Department. Read more about this study
- Who is it for?
- Ages 2 days to 6 years
- Conditions the study is for
- Wheeze
- What is being tested?
- hypertonic saline and saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Nov 2013
- 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 2 days to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age under 6 years
- History of viral upper respiratory infection within previous 7 days
- Wheezing or crackles detected on chest auscultation
- Respiratory Distress Assessment Instrument (RDAI) score of 4 or greater or oxygen saturation (SaO2) of 94% or less in room air.
Who cannot join
- History of immunodeficiency, chronic cardiopulmonary disease (other than past history of wheezing), Down syndrome, gestational age under 34 weeks.
- Severe illness at presentation as defined by any of the following
- respiratory rate greater than 80/min
- SaO2 less than 88% in room air
- need for assisted ventilation
- Use of nebulized HS within previous 12 hours
- Presence of active varicella infection.
About this study
Hypothesis: substitution of nebulized 3% NaCl (HS) for the standard normal saline (NS) used in bronchodilator therapy for acute viral wheezing in all children under age 6 years will provide superior symptom relief leading to decreased admission rates from the Emergency Department.
The study will test the efficacy of frequent doses of inhaled bronchodilator co-administered with either 3% hypertonic saline (HS, study group) or 0.9% normal saline (NS, control group) in a prospective, double blind, randomized controlled, multi-centre clinical trial of children under age 6 years presenting to the ED with acute viral-associated wheezing.
Read the detailed description
the brief summary captures the essence of the study
- Conditions
- Wheeze
- Being tested
- hypertonic saline, saline
- Keywords
- wheeze, early childhood, asthma, bronchiolitis, infection triggered
- Medical subject headings
- Respiratory Sounds, Asthma, Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypertonic salineOther
Also called nebulized hypertonic saline, aerosolized hypertonic saline
inhaled nebulized 3%NaCl
salineOther
Also called nebulized saline, aerosolized saline
inhaled nebulized 0.9% NaCl
| Study group | Role | What they receive |
|---|---|---|
| hypertonic saline | Experimental | inhalation of 4 ml nebulized study solution containing 3% hypertonic saline (HS, study group). Each dose of study solution will also contain a standard dose of bronchodilator (salbutamol, 0.15 mg/kg; 0.03 ml/kg of 0.5% salbutamol nebulizer solution) 1,2 added by the ED staff. Initial therapy will consist of 3 consecutive nebulizations given in rapid succession (back-to-back, approximately every 20 minutes). Receives: Other: hypertonic saline |
| saline | Active comparator | inhalation of 4 ml nebulized study solution containing saline 0.9% saline (NS, control group). Each dose of study solution will also contain a standard dose of bronchodilator (salbutamol, 0.15 mg/kg; 0.03 ml/kg of 0.5% salbutamol nebulizer solution) 1,2 added by the ED staff. Initial therapy will consist of 3 consecutive nebulizations given in rapid succession (back-to-back, approximately every 20 minutes). Receives: Other: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of admission to hospital
Rates of admission to hospital
Measured: duration of hospital ER stay, an average of 4 hours
Secondary outcomes (5)
Improvement in respiratory distress scores after initial protocol treatment in the ED
Improvement in respiratory distress scores after initial protocol treatment in the ED
Measured: time from pre-intervention assessment to post-intervention assessment, an average of 2 hours
Length-of-stay in the ED in the subgroup of patients not admitted
Length-of-stay in the ED in the subgroup of patients not admitted
Measured: an average of 6 hours
Cumulative dose of bronchodilator administered in ED prior to admission/discharge order
Cumulative dose of bronchodilator administered in ED prior to admission/discharge order
Measured: an average of 6 hours
Length of hospital stay in the those who are admitted
Length of hospital stay in the those who are admitted
Measured: length of hospital stay, an average of 3 days
Rate of return visit to ED (for respiratory illness) within 14 days of enrollment
Rate of return visit to ED (for respiratory illness) within 14 days of enrollment
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startOct 2013
- Primary completionNov 2013
- Study completionNov 2013
Why it stopped: Funding declined. Study never initiated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WheezeStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Michael Flavin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Michael Flavin, Queen's University
- Investigators
- Michael Flavin, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01868932
- Sponsor's protocol ID
- TWICS
- Other IDs
- HSTWICS
- Acronym
- TWICS
- Status last verified
- Jan 2014
- First submitted
- 28 May 2013
- Last updated
- 13 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Wheezing in Children With Hypertonic Saline (TWICS)
- ClinicalTrials.gov ID
- NCT01868932
- Acronym / sponsor ID
- TWICS / TWICS
- Conditions
- Wheeze
- Keywords
- wheeze, early childhood, asthma, bronchiolitis, infection triggered
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding declined. Study never initiated.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Dr. Michael FlavinUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 5 Jun 2013 (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.
Hypothesis: substitution of nebulized 3% NaCl (HS) for the standard normal saline (NS) used in bronchodilator therapy for acute viral wheezing in all children under age 6 years will provide superior symptom relief leading to decreased admission rates from the Emergency Department.
The study will test the efficacy of frequent doses of inhaled bronchodilator co-administered with either 3% hypertonic saline (HS, study group) or 0.9% normal saline (NS, control group) in a prospective, double blind, randomized controlled, multi-centre clinical trial of children under age 6 years presenting to the ED with acute viral-associated wheezing.
Detailed description
the brief summary captures the essence of the study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hypertonic saline | Experimental | Other: hypertonic salineinhalation of 4 ml nebulized study solution containing 3% hypertonic saline (HS, study group). Each dose of study solution will also contain a standard dose of bronchodilator (salbutamol, 0.15 mg/kg; 0.03 ml/kg of 0.5% salbutamol nebulizer solution) 1,2 added by the ED staff. Initial therapy will consist of 3 consecutive nebulizations given in rapid succession (back-to-back, approximately every 20 minutes). |
| saline | Active comparator | Other: salineinhalation of 4 ml nebulized study solution containing saline 0.9% saline (NS, control group). Each dose of study solution will also contain a standard dose of bronchodilator (salbutamol, 0.15 mg/kg; 0.03 ml/kg of 0.5% salbutamol nebulizer solution) 1,2 added by the ED staff. Initial therapy will consist of 3 consecutive nebulizations given in rapid succession (back-to-back, approximately every 20 minutes). |
Who may qualify
- Ages
- 2 days to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Age under 6 years
- History of viral upper respiratory infection within previous 7 days
- Wheezing or crackles detected on chest auscultation
- Respiratory Distress Assessment Instrument (RDAI) score of 4 or greater or oxygen saturation (SaO2) of 94% or less in room air.
Key exclusion criteria (7 listed)
- History of immunodeficiency, chronic cardiopulmonary disease (other than past history of wheezing), Down syndrome, gestational age under 34 weeks.
- Severe illness at presentation as defined by any of the following
- Use of nebulized HS within previous 12 hours
- Presence of active varicella infection.
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 salineAlso: nebulized hypertonic saline, aerosolized hypertonic salineinhaled nebulized 3%NaCl | Other | hypertonic saline |
| salineAlso: nebulized saline, aerosolized salineinhaled nebulized 0.9% NaCl | Other | saline |
Primary outcome
Rates of admission to hospital
Time frame: duration of hospital ER stay, an average of 4 hours
Rates of admission to hospital
5 secondary outcomes
Improvement in respiratory distress scores after initial protocol treatment in the ED
Time frame: time from pre-intervention assessment to post-intervention assessment, an average of 2 hours
Length-of-stay in the ED in the subgroup of patients not admitted
Time frame: an average of 6 hours
Cumulative dose of bronchodilator administered in ED prior to admission/discharge order
Time frame: an average of 6 hours
Length of hospital stay in the those who are admitted
Time frame: length of hospital stay, an average of 3 days
Rate of return visit to ED (for respiratory illness) within 14 days of enrollment
Time frame: 14 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2015.
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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.
Michael Flavin principal investigator
Queen's University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing hypertonic saline and saline in people with Wheeze, run by Dr. Michael Flavin.
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 4 inclusion and 7 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: withdrawn, as of the sponsor's last update on 13 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of admission to hospital (time frame: duration of hospital ER stay, an average of 4 hours). 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 13 Nov 2015.