CroupPhase 3NCT01748162
Management of Recurrent Croup
A Phase 3 study testing Fluticasone and Prednisolone IF needed in people with Croup, run by University of Michigan at 1 site in United States.
Trial summary
Presently children who experience recurring croup symptoms receive a variety of treatments. This is because it is not clear which treatments may be best. Some children are given inhaled steroids (similar to what children with asthma use). Read more about this study
- Who is it for?
- Ages 6 months to 15 years
- Conditions the study is for
- Croup
- What is being tested?
- Fluticasone and Prednisolone IF needed
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Jun 2014
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 months to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pediatric population: 6 months to 15 years of age
- 2 or more episodes of croup in 12 month period
- croup defined as acute onset inspiratory stridor, barking cough, with respiratory distress.
Who cannot join
- Grade 3 or 4 subglottic stenosis
- Subglottic hemangioma
- Posterior laryngeal cleft
- Recurrent respiratory papillomatosis
- External compression (Innominate artery compression, mediastinal mass, (double aortic arch, etc)
- Symptoms or signs suggesting another cause of stridor, such as epiglottitis, bacterial tracheitis, or supraglottic foreign body
Show all 9Show fewer
- Tracheomalacia/ bronchomalacia severe enough to cause respiratory distress
- Current steroid therapy for previously diagnosed condition, i.e. reactive airway disease.
- Other medical conditions necessitating chronic steroid utilization
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Management of Recurrent Croup: Comparison Between Inhaled Fluticasone and Oral Prednisolone
Presently children who experience recurring croup symptoms receive a variety of treatments. This is because it is not clear which treatments may be best. Some children are given inhaled steroids (similar to what children with asthma use). Others are carefully watched and cautioned to avoid potential triggers (certain foods, environmental allergens, etc), and should episodes of croup recur they are treated with a short course of oral steroids. The purpose of this study is to compare two safe and clinically appropriate methods for treating recurrent croup, daily inhaled steroids versus observation with oral steroids on an as needed basis, to see if either is useful in preventing future episodes of croup.
- Conditions
- Croup
- Being tested
- Fluticasone, Prednisolone IF needed
- Keywords
- croup, recurrent croup, barky cough
- Medical subject headings
- Croup
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FluticasoneDrug
Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months.
Prednisolone IF neededDrug
| Study group | Role | What they receive |
|---|---|---|
| Inhaled steroids | Experimental | Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months. Receives: Drug: Fluticasone |
| Oral control | Active comparator | Patient and clinician observation with short term oral prednisolone as needed. Offered at 1mg/kg (body weight) daily dosing for symptomatic treatment on as needed basis for three days, but may be modified per managing physician's discretion. Receives: Drug: Prednisolone IF needed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantity of Recurrent Episodes
Quantity of recurrent croup episodes experienced over a 1 year period by each participating subject.
Measured: 1 year
Secondary outcomes (1)
Severity of Croup Episodes
Severity of recurrent croup episodes based on Westley Croup scale (0 - 17, where 0 is mildest croup symptoms and 17 is most severe symptoms.)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2012 (estimated)
- Study startSep 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CroupStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Brown, University of Michigan
- Investigators
- David J Brown, MD, Principal investigator, University of Michigan Department of Otolaryngology-Head & Neck Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01748162
- Sponsor's protocol ID
- 00059385
- Status last verified
- Nov 2017
- First submitted
- 31 Oct 2012
- Last updated
- 13 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Recurrent Croup: Comparison Between Inhaled Fluticasone and Oral Prednisolone
- ClinicalTrials.gov ID
- NCT01748162
- Acronym / sponsor ID
- 00059385
- Conditions
- Croup
- Keywords
- croup, recurrent croup, barky cough
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 12 Dec 2012 (estimated)
- Results
- Posted 13 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Presently children who experience recurring croup symptoms receive a variety of treatments. This is because it is not clear which treatments may be best. Some children are given inhaled steroids (similar to what children with asthma use). Others are carefully watched and cautioned to avoid potential triggers (certain foods, environmental allergens, etc), and should episodes of croup recur they are treated with a short course of oral steroids. The purpose of this study is to compare two safe and clinically appropriate methods for treating recurrent croup, daily inhaled steroids versus observation with oral steroids on an as needed basis, to see if either is useful in preventing future episodes of croup.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhaled steroids | Experimental | Drug: FluticasoneDaily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months. |
| Oral control | Active comparator | Drug: Prednisolone IF neededPatient and clinician observation with short term oral prednisolone as needed. Offered at 1mg/kg (body weight) daily dosing for symptomatic treatment on as needed basis for three days, but may be modified per managing physician's discretion. |
Who may qualify
- Ages
- 6 months to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Pediatric population: 6 months to 15 years of age
- 2 or more episodes of croup in 12 month period
Key exclusion criteria (9 listed)
- Grade 3 or 4 subglottic stenosis
- Subglottic hemangioma
- Posterior laryngeal cleft
- Recurrent respiratory papillomatosis
- External compression (Innominate artery compression, mediastinal mass, (double aortic arch, etc)
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 |
|---|---|---|
| FluticasoneDaily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months. | Drug | Inhaled steroids |
| Prednisolone IF needed | Drug | Oral control |
Primary outcome
Quantity of Recurrent Episodes
Time frame: 1 year
Quantity of recurrent croup episodes experienced over a 1 year period by each participating subject.
1 secondary outcome
Severity of Croup Episodes
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Please visit our Department Facebook page for information regarding the studyLink provided by the sponsor.
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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.
David J Brown, MD principal investigator
University of Michigan Department of Otolaryngology-Head & Neck Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fluticasone and Prednisolone IF needed in people with Croup, run by University of Michigan at 1 site in United States.
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 3 inclusion and 9 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: stopped early, as of the sponsor's last update on 13 Nov 2017. 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 States. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Quantity of Recurrent Episodes (time frame: 1 year). 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 2017.