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Completed

NCT Number: NCT01503957

Nasya in Allergic Rhinitis

The purpose of this study is to evaluate safety and efficacy of Nasya in reducing symptoms of persistent allergic rhinitis when applied before allergen challenge.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Campus Charité Mitte Klinik und Poliklinik für Hals-, Nasen-, Ohren- heilkunde Charité - Universitätsmedizin Berlin, Charitéplatz 1

Berlin, State of Berlin, 10117, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • History of persistent allergic rhinitis due to house dust mite allergy ≥ 2 years
  • Written informed consent

Exclusion criteria

  • Clinically significant disease that could interfere with the evaluation of study medication
  • Participation in other studies within the last 4 weeks / during the study

Treatment and study plan

Nasya

Device

Thixotropic nasal spray suspension, 2 sprays in each nostril

Saline solution

Device

Nasal spray, 2 sprays in each nostril

Primary outcomes

  1. Difference in Total Nasal Symptom Score

    Time frame: 75 minutes

Secondary outcomes

  1. Difference in Total Nasal Symptom Score

    Time frame: Up to 240 minutes

  2. Difference in Total Ocular Symptom Score

    Time frame: Up to 240 minutes

Sponsors and collaborators

Lead sponsor

InQpharm Group

Industry

Registry information

Official study title

Double-blind, Randomized, Placebo-controlled, Crossover Clinical Investigation to Evaluate Safety and Efficacy of Nasya in Reducing Symptoms of Allergic Rhinitis When Applied Before Allergen Challenge

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 4, 2012
Registry last updated
Oct 26, 2012

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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