Perennial Allergic Rhinitis
Conditions
Keywords
allergy
Brief 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).
Interventions
DRUGBudesonide
Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily
DRUGPlacebo
Placebo delivered intranasally via NasoNeb nebulizer once daily
Sponsors
MedInvent, LLC
University of Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
1. Males and females between 18 and 55 years of age. 2. History of perennial allergic rhinitis. 3. Positive skin test to dust mite, dog, cat or indoor mold antigen. 4. 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.
Exclusion criteria
1. Physical signs or symptoms suggestive of renal, hepatic or cardiovascular disease. 2. Pregnant or lactating women. 3. Subjects treated with systemic steroids during the previous 30 days. 4. Subjects treated with topical (inhaled, intranasal or intraocular) steroids, Nasalcrom or Opticrom during the previous 30 days. 5. Subjects treated with oral antihistamine/decongestants during the previous seven days. 6. Subjects treated with topical (intranasal or intraocular) antihistamine/decongestants during the previous 3 days. 7. Subjects treated with immunotherapy and are escalating their dose. 8. Subjects on chronic anti-asthma medications. 9. Subjects with polyps in the nose or a significantly displaced septum. 10. Upper respiratory infection within 14 days prior to study start.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Nasal Peak Inspiratory Flow (NPIF) | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Budesonide Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily | 20 |
| Placebo Placebo delivered intranasally via NasoNeb nebulizer once daily | 20 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Budesonide | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 33.3 years | 32.3 years | 32.8 years |
| Sex: Female, Male Female | 7 Participants | 11 Participants | 18 Participants |
| Sex: Female, Male Male | 13 Participants | 9 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
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
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Budesonide | Change in Nasal Peak Inspiratory Flow (NPIF) | 36.41 liters/min | Standard Error 8.9 |
| Placebo | Change in Nasal Peak Inspiratory Flow (NPIF) | 18.71 liters/min | Standard Error 8.37 |