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Nasya in Allergic Rhinitis

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ClinicalTrials.gov Identifier: NCT01503957
Recruitment Status : Completed
First Posted : January 4, 2012
Last Update Posted : October 26, 2012
Sponsor:
Information provided by (Responsible Party):
InQpharm Group

Brief Summary:
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 or disease Intervention/treatment Phase
Allergic Rhinitis Device: Nasya Device: Saline solution Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : January 2012
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Difference in Total Nasal Symptom Score [ Time Frame: 75 minutes ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: InQpharm Group
ClinicalTrials.gov Identifier: NCT01503957     History of Changes
Other Study ID Numbers: INQ/023411
First Posted: January 4, 2012    Key Record Dates
Last Update Posted: October 26, 2012
Last Verified: October 2012

Keywords provided by InQpharm Group:
Allergic rhinitis
Allergen
Allergy
Dustmite

Additional relevant MeSH terms:
Rhinitis
Rhinitis, Allergic
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases