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Nasya in Allergic Rhinitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01503957
First Posted: January 4, 2012
Last Update Posted: October 26, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
InQpharm Group
  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
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

Further study details as provided by InQpharm Group:

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

Secondary Outcome Measures:
  • Difference in Total Nasal Symptom Score [ Time Frame: Up to 240 minutes ]
  • Difference in Total Ocular Symptom Score [ Time Frame: Up to 240 minutes ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Responsible Party: InQpharm Group
ClinicalTrials.gov Identifier: NCT01503957     History of Changes
Other Study ID Numbers: INQ/023411
First Submitted: December 27, 2011
First Posted: January 4, 2012
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