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Allergen Biocube Study Evaluating Efficacy and Safety of Nasapaque Nasal Solution in Adult Subjects With Allergic Rhinitis

A Single-Center, Double-Masked, Randomized, Placebo-Controlled, Parallel-Group Allergen BioCube Study Evaluating the Efficacy and Safety of Nasapaque Nasal Solution in a Population of Adult Subjects With Seasonal Allergic Rhinitis

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02377895
Enrollment
73
Registered
2015-03-04
Start date
2015-03-31
Completion date
2015-07-31
Last updated
2017-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Seasonal Allergic Rhinitis

Brief summary

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

Interventions

DRUGNasapaque Nasal Solution
DRUGPlacebo Saline Nasal Solution

Sponsors

ORA, Inc.
CollaboratorINDUSTRY
3E Therapeutics Corporation
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Key Inclusion Criteria: * 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 Key

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frame
TNSS Total Nasal Symptom ScoreDay 1 and Day 8

Secondary

MeasureTime frame
Nasal Inspiratory FlowDay 1 and Day 8
Nasal Inflammation ScoreDay 1 and Day 8

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026