A Phase 4 interventional study of Budesonide and Placebo in Perennial Allergic Rhinitis, sponsored by University of Chicago. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2014-07-25.
Sponsored by University of Chicago · Phase 4, Interventional, and Treatment
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).
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's enrollment of 41 is below the median of 89 across 906 interventional studies indexed under Rhinitis.
Browse Rhinitis studies →University of Chicago is the lead sponsor of 907 studies on the registry; 182 are open to participants now.
Of its 99 completed or terminated interventional studies of FDA-regulated products, 68 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria
Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily
Drug: Budesonide
Placebo delivered intranasally via NasoNeb nebulizer once daily
Drug: Placebo
Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily
Placebo delivered intranasally via NasoNeb nebulizer once daily
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
Time frame: Baseline and 26 days
| Milestone | Budesonide | Placebo |
|---|---|---|
| Started | 21 | 20 |
| Completed | 20 | 20 |
| Not completed | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 0 |
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
| liters/min | Budesonide | Placebo |
|---|---|---|
| Change in Nasal Peak Inspiratory Flow (NPIF) | 36.41 ± 8.9 | 18.71 ± 8.37 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Budesonide | — | 0/20 (0%) | 0/20 (0%) |
| Placebo | — | 0/20 (0%) | 0/20 (0%) |
| Age, Continuous(years) | Budesonide | Placebo | Total |
|---|---|---|---|
| Mean | 33.3 (18 to 55) | 32.3 (18 to 52) | 32.8 (18 to 55) |
| Sex: Female, Male(Participants) | Budesonide | Placebo | Total |
|---|---|---|---|
| Female | 7 | 11 | 18 |
| Male | 13 | 9 | 22 |
This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.
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University of Chicago