NCT01503957

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 27, 2011

Completed
5 days until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 4, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

October 26, 2012

Status Verified

October 1, 2012

Enrollment Period

8 months

First QC Date

December 27, 2011

Last Update Submit

October 25, 2012

Conditions

Allergic Rhinitis

Keywords

Allergic rhinitisAllergenAllergyDustmite

Outcome Measures

Primary Outcomes (1)

  • Difference in Total Nasal Symptom Score

    75 minutes

Secondary Outcomes (2)

  • Difference in Total Nasal Symptom Score

    Up to 240 minutes

  • Difference in Total Ocular Symptom Score

    Up to 240 minutes

Study Arms (2)

Saline solution

PLACEBO COMPARATOR

Nasal spray

Device: Saline solution

Nasya

EXPERIMENTAL

Thixotropic nasal spray suspension

Device: Nasya

Interventions

NasyaDEVICE

Thixotropic nasal spray suspension, 2 sprays in each nostril

Nasya
Saline solutionDEVICE

Nasal spray, 2 sprays in each nostril

Saline solution

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Berlin, State of Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Rhinitis, AllergicHypersensitivity

Interventions

Abortion, Induced

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateImmune System Diseases

Intervention Hierarchy (Ancestors)

Obstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Minoo Lenarz, MD

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2011

First Posted

January 4, 2012

Study Start

January 1, 2012

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

October 26, 2012

Record last verified: 2012-10

Locations

DE(1)