NCT01270256

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

January 3, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 5, 2011

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
2 years until next milestone

Results Posted

Study results publicly available

July 16, 2014

Completed
Last Updated

July 25, 2014

Status Verified

July 1, 2014

Enrollment Period

1.5 years

First QC Date

January 3, 2011

Results QC Date

June 16, 2014

Last Update Submit

July 17, 2014

Conditions

Perennial Allergic Rhinitis

Keywords

allergy

Outcome Measures

Primary Outcomes (1)

  • 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

    Baseline and 26 days

Study Arms (2)

Budesonide

ACTIVE COMPARATOR

Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily

Drug: Budesonide

Placebo

PLACEBO COMPARATOR

Placebo delivered intranasally via NasoNeb nebulizer once daily

Drug: Placebo

Interventions

BudesonideDRUG

Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily

Budesonide
PlaceboDRUG

Placebo delivered intranasally via NasoNeb nebulizer once daily

Placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Related Publications (1)

  • 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.

    PMID: 24574125DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic, PerennialHypersensitivity

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Results Point of Contact

Title
Dr. Robert M Naclerio
Organization
University of Chicago
rnackeri@surgery.bsd.uchicago.edu
773-702-0080

Study Officials

  • Robert M Naclerio, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2011

First Posted

January 5, 2011

Study Start

January 1, 2011

Primary Completion

July 1, 2012

Study Completion

August 1, 2012

Last Updated

July 25, 2014

Results First Posted

July 16, 2014

Record last verified: 2014-07

Locations

US(1)