Nasya in Allergic Rhinitis | NCT01503957

Studies
Nasya in Allergic Rhinitis

NCT01503957

Sponsor

InQpharm Group

Status

Completed

Last Update Posted

Oct 26, 2012Estimated

Enrollment

20Actual

Phase

Phase 3

Conditions

Allergic Rhinitis

Interventions

Nasya
Saline solution

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Sep 2012Actual

Completion Date

Sep 2012Actual

First Submitted Date

Dec 27, 2011

First Submission Date that Met QC Criteria

Jan 2, 2012

First Posted Date

Jan 4, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 25, 2012

Last Update Posted Date

Oct 26, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Saline solution	Placebo Comparator	Nasal spray	Device: Saline solution
Nasya	Experimental	Thixotropic nasal spray suspension	Device: Nasya

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Nasya	Device	Thixotropic nasal spray suspension, 2 sprays in each nostril	Nasya

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Difference in Total Nasal Symptom Score		75 minutes

Secondary Outcomes

Measure	Description	Time Frame
Difference in Total Nasal Symptom Score		Up to 240 minutes
Difference in Total Ocular Symptom Score		Up to 240 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Minoo Lenarz, MD	Charite University, Berlin, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Campus Charité Mitte Klinik und Poliklinik für Hals-, Nasen-, Ohren- heilkunde Charité - Universitätsmedizin Berlin, Charitéplatz 1		Berlin	State of Berlin	10117	Germany

Condition Browse Module

MeSH Terms

ID	Term
D065631	Rhinitis, Allergic
D006967	Hypersensitivity

Ancestor Terms

ID	Term
D012220	Rhinitis
D009668	Nose Diseases
D012140	Respiratory Tract Diseases
D012130	Respiratory Hypersensitivity

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000028	Abortion, Induced

Ancestor Terms

ID	Term
D013513	Obstetric Surgical Procedures
D013514	Surgical Procedures, Operative

Browse Leaves

Not provided

Browse Branches

Not provided