NCT02377895

Brief Summary

Single-center, double-masked, randomized, placebo-controlled, parallel-group, efficacy and safety study using the Allergen BioCube (ABC).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
73

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Mar 2015

Shorter than P25 for phase_1

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

First Submitted

Initial submission to the registry

February 27, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 4, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

January 26, 2017

Status Verified

January 1, 2017

Enrollment Period

4 months

First QC Date

February 27, 2015

Last Update Submit

January 25, 2017

Conditions

Seasonal Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

  • TNSS Total Nasal Symptom Score

    Day 1 and Day 8

Secondary Outcomes (2)

  • Nasal Inspiratory Flow

    Day 1 and Day 8

  • Nasal Inflammation Score

    Day 1 and Day 8

Study Arms (2)

Nasapaque Nasal Solution

EXPERIMENTAL

250 ul in each nostril at Day 1 and Day 8

Drug: Nasapaque Nasal Solution

Placebo Saline Nasal Solution

ACTIVE COMPARATOR

250 ul in each nostril at Day 1 and Day 8

Drug: Placebo Saline Nasal Solution

Interventions

Nasapaque Nasal SolutionDRUG
Nasapaque Nasal Solution
Placebo Saline Nasal SolutionDRUG
Placebo Saline Nasal Solution

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must be 18 years of age and provide written informed consent and sign the HIPAA form
  • Must have history of allergic rhinitis
  • Must have positive response to Allergen BioCube

You may not qualify if:

  • Must not have a significant illness such as moderate to severe allergic asthmatic reactions
  • Must not have compromised lung function
  • Must not use any disallowed medications
  • Must not have been in an investigational study in the last 30 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Gomes PJ, Abelson MB, Stein L, Viirre E, Villafranca JE, Lasser EC. Iodixanol nasal solution reduces allergic rhinoconjunctivitis signs and symptoms in Allergen BioCube(R): a randomized clinical trial. J Asthma Allergy. 2019 Mar 1;12:71-81. doi: 10.2147/JAA.S150251. eCollection 2019.

    PMID: 30881050DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2015

First Posted

March 4, 2015

Study Start

March 1, 2015

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

January 26, 2017

Record last verified: 2017-01