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Completed

NCT Number: NCT02377895

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

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

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Key information

Conditions

Seasonal Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nasapaque Nasal Solution

Drug

Placebo Saline Nasal Solution

Drug

Primary outcomes

  1. TNSS Total Nasal Symptom Score

    Time frame: Day 1 and Day 8

Secondary outcomes

  1. Nasal Inspiratory Flow

    Time frame: Day 1 and Day 8

  2. Nasal Inflammation Score

    Time frame: Day 1 and Day 8

Sponsors and collaborators

Lead sponsor

3E Therapeutics Corporation

Industry

Collaborators

  • ORA, Inc.

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Mar 4, 2015
Registry last updated
Jan 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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