SinusitisPhase 2/3NCT01907204
Evaluation of Inhaled Treatment in Sinusitis
A Phase 2/3 study testing methylprednisolone and Budesonide in people with Sinusitis, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
Trial summary
The purpose of this study is to determine whether inhaled corticosteroid (specially nebulized) could be a good alternative to oral corticosteroid and whether they are effective in the treatment of sinusitis Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sinusitis
- What is being tested?
- methylprednisolone and Budesonide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jul 2013to Jan 2014
- Phase
- Phase 2/3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Nasal/Sinus polyps
Who cannot join
- Previous sinus surgery
- Age under 18y
- Use of antibiotics
About this study
Official title: Evaluation of Inhaled Corticosteroid Treatment in Sinusitis
The purpose of this study is to determine whether inhaled corticosteroid (specially nebulized) could be a good alternative to oral corticosteroid and whether they are effective in the treatment of sinusitis
- Conditions
- Sinusitis
- Being tested
- methylprednisolone, Budesonide
- Medical subject headings
- Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral 32mg/8d-16mg/4d-8mg/4d
BudesonideDrug
Budesonide by metered dose inhaler
BudesonideDrug
Budesonide by nebulization
| Study group | Role | What they receive |
|---|---|---|
| Oral | Active comparator | Oral drug (methylprednisolone) administration Receives: Drug: methylprednisolone |
| Metered dose inhaler | Experimental | Not described Receives: Drug: Budesonide |
| Nebulized | Experimental | Not described Receives: Drug: Budesonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sniffin' Sticks Test
Measured: Baseline and day 15
Secondary outcomes (2)
Specific quality of life questionnaire (Snot 20)
Measured: Baseline and day 15
Retro Olfaction Test
Measured: Baseline and day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionAug 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SinusitisStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, G.Reychler, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Investigators
- Gregory Reychler, PhD, Study director, Cliniques universitaires Saint-Luc- Université Catholique de LouvainPhilippe Rombaux, Prof PhD, Study director, Cliniques universitaires Saint-Luc- Université Catholique de LouvainCoralie Colbrant, PT, Principal investigator, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01907204
- Sponsor's protocol ID
- Sinusitis001
- Status last verified
- Jan 2014
- First submitted
- 12 Jul 2013
- Last updated
- 27 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Inhaled Corticosteroid Treatment in Sinusitis
- ClinicalTrials.gov ID
- NCT01907204
- Acronym / sponsor ID
- Sinusitis001
- Conditions
- Sinusitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Aug 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 24 Jul 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.
The purpose of this study is to determine whether inhaled corticosteroid (specially nebulized) could be a good alternative to oral corticosteroid and whether they are effective in the treatment of sinusitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oral | Active comparator | Drug: methylprednisoloneOral drug (methylprednisolone) administration |
| Metered dose inhaler | Experimental | Drug: Budesonide |
| Nebulized | Experimental | Drug: Budesonide |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Nasal/Sinus polyps
Key exclusion criteria (3 listed)
- Previous sinus surgery
- Age under 18y
- Use of antibiotics
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 |
|---|---|---|
| methylprednisoloneOral 32mg/8d-16mg/4d-8mg/4d | Drug | Oral |
| BudesonideBudesonide by metered dose inhaler | Drug | Metered dose inhaler |
| BudesonideBudesonide by nebulization | Drug | Nebulized |
Primary outcome
Sniffin' Sticks Test
Time frame: Baseline and day 15
2 secondary outcomes
Specific quality of life questionnaire (Snot 20)
Time frame: Baseline and day 15
Retro Olfaction Test
Time frame: Baseline and day 15
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2014.
Related trials for Sinusitis
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A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
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Active, not recruitingPhase 3
Clinical Trial of TQC2731 Injection in Patients With Chronic Sinusitis and Nasal Polyps
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FESS With or Without Intranasal Desmopressin in Chronic Rhinosinusitis With Nasal Polyps
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RecruitingPhase 4
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ACUTE SINUSITIS, Sinusitis
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.
Gregory Reychler, PhD study director
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Philippe Rombaux, Prof PhD study director
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Coralie Colbrant, PT principal investigator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing methylprednisolone and Budesonide in people with Sinusitis, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain.
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 1 inclusion and 3 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: finished, as of the sponsor's last update on 27 Jan 2014. 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 combined 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.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Sniffin' Sticks Test (time frame: Baseline and day 15). 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 27 Jan 2014.