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Nasya in Allergic Rhinitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
InQpharm Group
ClinicalTrials.gov Identifier:
NCT01503957
First received: December 27, 2011
Last updated: October 25, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Allergic Rhinitis
 Device: Nasya
Device: Saline solution
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official 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

Further study details as provided by InQpharm Group:

Primary Outcome Measures:
  • Difference in Total Nasal Symptom Score [ Time Frame: 75 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Difference in Total Nasal Symptom Score [ Time Frame: Up to 240 minutes ] [ Designated as safety issue: No ]
  • Difference in Total Ocular Symptom Score [ Time Frame: Up to 240 minutes ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: January 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Saline solution
Nasal spray
 Device: Saline solution
Nasal spray, 2 sprays in each nostril
Experimental: Nasya
Thixotropic nasal spray suspension
 Device: Nasya
Thixotropic nasal spray suspension, 2 sprays in each nostril

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01503957

Locations
Germany
Campus Charité Mitte Klinik und Poliklinik für Hals-, Nasen-, Ohren- heilkunde Charité - Universitätsmedizin Berlin, Charitéplatz 1
Berlin, Germany, 10117
Sponsors and Collaborators
InQpharm Group
Investigators
Principal Investigator: Minoo Lenarz, MD Charite University, Berlin, Germany
  More Information

No publications provided

Responsible Party: InQpharm Group
ClinicalTrials.gov Identifier: NCT01503957     History of Changes
Other Study ID Numbers: INQ/023411
Study First Received: December 27, 2011
Last Updated: October 25, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by InQpharm Group:
Allergic rhinitis
Allergen
Allergy
Dustmite

Additional relevant MeSH terms:
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 19, 2013