Chronic SinusitisPhase 3NCT01197612
Nasal Packing as a Drug Delivery System Postoperatively in Chronic Sinusitis With Polyposis
A Phase 3 study testing pulmicort in people with Chronic Sinusitis and Polyposis, run by University of Michigan at 1 site in United States.
Trial summary
That high-dose steroid applied to the nasal cavity immediately post-operatively will improve olfaction and healing following endoscopic sinus surgery. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Chronic Sinusitis, Polyposis
- What is being tested?
- pulmicort
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Jun 2012
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hyposmia and nasal obstruction for >12 weeks
- bilateral nasal polyposis
- candidate for surgery
Who cannot join
- immunocompromised
- non-English speaking
- prisoner
- pregnant/lactating
- will not attend follow up appointments
Trial locations and contacts
1 site in 1 country.
About this study
That high-dose steroid applied to the nasal cavity immediately post-operatively will improve olfaction and healing following endoscopic sinus surgery.
- Conditions
- Chronic Sinusitis, Polyposis
- Being tested
- pulmicort
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pulmicortDrug
Also called budesonide
applied to nasal packing after surgery
| Study group | Role | What they receive |
|---|---|---|
| Single Arm; nostrils as experimental and comparator | Other | each subject serves as their own control with one nostril being treated with pulmicort and one not Receives: Drug: pulmicort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Olfaction
will be measured with the University of Pennsylvania Smell Identification Test (UPSIT), whose scores range from 0 to 40, where 0 is the inability to smell anything and 40 is perfect smell identification
Measured: 3 weeks post-operation
Secondary outcomes (3)
Sinonasal Health
will be assessed with the Perioperative Sinus Endoscopy score (POSE), a 20 point scale where 0 is no sinus challenges and 20 represents the greatest blockage.
Measured: 3 weeks post operation
Olfaction
Scored with the University of Pennsylvania Smell Identification Test, whose scores range from 0 to 40, where 0 is the inability to smell anything and 40 is perfect smell identification
Measured: 24 weeks post operation
Sinonasal Health
Assessed with Perioperative Sinus Endoscopy (POSE) score
Measured: 24 weeks post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionJun 2012
- Study completionJun 2012
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 Chronic SinusitisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- American Rhinologic Society
- Responsible party
- Principal investigator, Garrett Griffin, University of Michigan
- Investigators
- Garrett R Griffin, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01197612
- Sponsor's protocol ID
- HUM00029273
- Status last verified
- Apr 2018
- First submitted
- 30 Aug 2010
- Last updated
- 29 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nasal Packing as a Drug Delivery System Postoperatively in Chronic Sinusitis With Polyposis
- ClinicalTrials.gov ID
- NCT01197612
- Acronym / sponsor ID
- HUM00029273
- Conditions
- Chronic Sinusitis, Polyposis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- American Rhinologic Society
- Study start
- Sep 2010 (actual)
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 9 Sep 2010 (estimated)
- Results
- Posted 29 May 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
That high-dose steroid applied to the nasal cavity immediately post-operatively will improve olfaction and healing following endoscopic sinus surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm; nostrils as experimental and comparator | Other | Drug: pulmicorteach subject serves as their own control with one nostril being treated with pulmicort and one not |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- hyposmia and nasal obstruction for >12 weeks
- bilateral nasal polyposis
- candidate for surgery
Key exclusion criteria (5 listed)
- immunocompromised
- non-English speaking
- prisoner
- pregnant/lactating
- will not attend follow up appointments
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 |
|---|---|---|
| pulmicortAlso: budesonideapplied to nasal packing after surgery | Drug | Single Arm; nostrils as experimental and comparator |
Primary outcome
Olfaction
Time frame: 3 weeks post-operation
will be measured with the University of Pennsylvania Smell Identification Test (UPSIT), whose scores range from 0 to 40, where 0 is the inability to smell anything and 40 is perfect smell identification
3 secondary outcomes
Sinonasal Health
Time frame: 3 weeks post operation
Olfaction
Time frame: 24 weeks post operation
Sinonasal Health
Time frame: 24 weeks post operation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Garrett R Griffin, MD principal investigator
University of Michigan
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 pulmicort in people with Chronic Sinusitis and Polyposis, 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 5 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 29 May 2018. 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 29 May 2018). 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?
Olfaction (time frame: 3 weeks post-operation). 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 29 May 2018.