Perennial Allergic RhinitisPhase 4NCT01270256
NasoNeb Delivery of an Intranasal Steroid
A Phase 4 study testing Budesonide in people with Perennial Allergic Rhinitis, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to see if a nasal steroid drug delivered to the nose with the NasoNeb™ inhaler improves the symptoms of people with perennial allergic rhinitis (year round allergy symptoms). Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Perennial Allergic Rhinitis
- What is being tested?
- Budesonide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Aug 2012
- Phase
- Phase 4
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males and females between 18 and 55 years of age.
- History of perennial allergic rhinitis.
- Positive skin test to dust mite, dog, cat or indoor mold antigen.
- And a combined nasal AM and PM score of ≥4 for nasal congestion in the day preceding entry and total nasal symptom score greater than 8.
Who cannot join
- Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
- Pregnant or lactating women.
- Subjects treated with systemic steroids during the previous 30 days.
- Subjects treated with topical (inhaled, intranasal or intraocular) steroids, Nasalcrom or Opticrom during the previous 30 days.
- Subjects treated with oral antihistamine/decongestants during the previous seven days.
- Subjects treated with topical (intranasal or intraocular) antihistamine/decongestants during the previous 3 days.
Show all 10Show fewer
- Subjects treated with immunotherapy and are escalating their dose.
- Subjects on chronic anti-asthma medications.
- Subjects with polyps in the nose or a significantly displaced septum.
- Upper respiratory infection within 14 days prior to study start.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of NasoNeb™ Delivery of an Intranasal Steroid in the Treatment of Perennial Allergic Rhinitis
The purpose of this study is to see if a nasal steroid drug delivered to the nose with the NasoNeb™ inhaler improves the symptoms of people with perennial allergic rhinitis (year round allergy symptoms).
- Conditions
- Perennial Allergic Rhinitis
- Being tested
- Budesonide, Placebo
- Keywords
- allergy
- Medical subject headings
- Rhinitis, Allergic, Perennial, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BudesonideDrug
Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily
PlaceboDrug
Placebo delivered intranasally via NasoNeb nebulizer once daily
| Study group | Role | What they receive |
|---|---|---|
| Budesonide | Active comparator | Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily Receives: Drug: Budesonide |
| Placebo | Placebo comparator | Placebo delivered intranasally via NasoNeb nebulizer once daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Nasal Peak Inspiratory Flow (NPIF)
NPIF was measured objectively in liters per minute with an In-Check Peak \& Inspiratory Flow Meter (Ferraris Medical Inc, Orchard Park, NY). Subjects obtained 3 readings every morning and every evening and the greatest of the 3 measures were recorded. Total daily NPIF was calculated by adding the morning and evening values each day and the average of the change from baseline in NPIF for all days of was calculated
Measured: Baseline and 26 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionJul 2012
- Study completionAug 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perennial Allergic RhinitisStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- MedInvent, LLC
- Responsible party
- Sponsor
- Investigators
- Robert M Naclerio, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01270256
- Sponsor's protocol ID
- 10-660-B
- Status last verified
- Jul 2014
- First submitted
- 3 Jan 2011
- Last updated
- 25 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Brown K, Lane J, Silva MP, DeTineo M, Naclerio RM, Baroody FM. A pilot study of the effects of intranasal budesonide delivered by NasoNeb(R) on patients with perennial allergic rhinitis. Int Forum Allergy Rhinol. 2014 Jan;4(1):43-8. doi: 10.1002/alr.21239.
PubMed 24574125
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of NasoNeb™ Delivery of an Intranasal Steroid in the Treatment of Perennial Allergic Rhinitis
- ClinicalTrials.gov ID
- NCT01270256
- Acronym / sponsor ID
- 10-660-B
- Conditions
- Perennial Allergic Rhinitis
- Keywords
- allergy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- MedInvent, LLC
- Study start
- Jan 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 5 Jan 2011 (estimated)
- Results
- Posted 16 Jul 2014
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 see if a nasal steroid drug delivered to the nose with the NasoNeb™ inhaler improves the symptoms of people with perennial allergic rhinitis (year round allergy symptoms).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Budesonide | Active comparator | Drug: BudesonidePulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo delivered intranasally via NasoNeb nebulizer once daily |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Males and females between 18 and 55 years of age.
- History of perennial allergic rhinitis.
- Positive skin test to dust mite, dog, cat or indoor mold antigen.
- And a combined nasal AM and PM score of ≥4 for nasal congestion in the day preceding entry and total nasal symptom score greater than 8.
Key exclusion criteria (10 listed)
- Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease.
- Pregnant or lactating women.
- Subjects treated with systemic steroids during the previous 30 days.
- Subjects treated with topical (inhaled, intranasal or intraocular) steroids, Nasalcrom or Opticrom during the previous 30 days.
- Subjects treated with oral antihistamine/decongestants during the previous seven days.
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 |
|---|---|---|
| BudesonidePulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily | Drug | Budesonide |
| PlaceboPlacebo delivered intranasally via NasoNeb nebulizer once daily | Drug | Placebo |
Primary outcome
Change in Nasal Peak Inspiratory Flow (NPIF)
Time frame: Baseline and 26 days
NPIF was measured objectively in liters per minute with an In-Check Peak \& Inspiratory Flow Meter (Ferraris Medical Inc, Orchard Park, NY). Subjects obtained 3 readings every morning and every evening and the greatest of the 3 measures were recorded. Total daily NPIF was calculated by adding the morning and evening values each day and the average of the change from baseline in NPIF for all days of was calculated
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24574125Brown K, Lane J, Silva MP, DeTineo M, Naclerio RM, Baroody FM. A pilot study of the effects of intranasal budesonide delivered by NasoNeb(R) on patients with perennial allergic rhinitis. Int Forum Allergy Rhinol. 2014 Jan;4(1):43-8. doi: 10.1002/alr.21239.
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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.
Robert M Naclerio, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Budesonide in people with Perennial Allergic Rhinitis, run by University of Chicago 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 4 inclusion and 10 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 25 Jul 2014. 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 16 Jul 2014). 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?
Change in Nasal Peak Inspiratory Flow (NPIF) (time frame: Baseline and 26 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01270256, which also lists 1 linked publication.
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 25 Jul 2014.