Trial Outcomes & Findings for NasoNeb Delivery of an Intranasal Steroid (NCT NCT01270256)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

41 participants

Primary outcome timeframe

Baseline and 26 days

Results posted on

2014-07-25

Participant Flow

Participant milestones

Participant milestones
Measure	Budesonide Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily	Placebo Placebo delivered intranasally via NasoNeb nebulizer once daily
Overall Study STARTED	21	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Budesonide Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily	Placebo Placebo delivered intranasally via NasoNeb nebulizer once daily
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

NasoNeb Delivery of an Intranasal Steroid

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Budesonide n=20 Participants Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily	Placebo n=20 Participants Placebo delivered intranasally via NasoNeb nebulizer once daily	Total n=40 Participants Total of all reporting groups
Age, Continuous	33.3 years n=5 Participants	32.3 years n=7 Participants	32.8 years n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	11 Participants n=7 Participants	18 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	9 Participants n=7 Participants	22 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Budesonide n=20 Participants Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily	Placebo n=20 Participants Placebo delivered intranasally via NasoNeb nebulizer once daily
Change in Nasal Peak Inspiratory Flow (NPIF)	36.41 liters/min Standard Error 8.9	18.71 liters/min Standard Error 8.37

Adverse Events

Budesonide

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Robert M Naclerio

University of Chicago

Phone: 773-702-0080

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place