Application of Ectoin Allergy Nasal Spray in Comparison t... | NCT02133053

Studies
Application of Ectoin Allergy Nasal Spray in Comparison to Beclomethasone Nasal Spray

NCT02133053

Sponsor

Bitop AG

Status

Completed

Last Update Posted

May 7, 2014Estimated

Enrollment

50Actual

Phase

Not provided

Conditions

Allergic Rhinitis

Interventions

Medical Device, drug-like
Beclomethasone

Countries

Not provided

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

May 2014

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

May 2011

Primary Completion Date

Jul 2011Actual

Completion Date

Jul 2011Actual

First Submitted Date

May 2, 2014

First Submission Date that Met QC Criteria

May 6, 2014

First Posted Date

May 7, 2014Estimated

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

May 6, 2014

Last Update Posted Date

May 7, 2014Estimated

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

This is a comparative, open label, parallel group, non interventional study to further demonstrate the effectiveness and tolerability of Ectoin® Allergy Nasal Spray. In addition the effectiveness and safety shall be compared to a Beclomethasone nasal spray. The patient applies Ectoin® Rhinitis Nasal Spray or Beclomethasone nasal spray according to the instructions for use. The observation takes place over a period of 14 days. Response to treatment is recorded at day 7 and day 14 by the physician and in daily by the patient in a dairy.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ectoin Group		Ectoin Allergy Nasal Spray (Medical Device, drug-like)	Other: Medical Device, drug-like
Beclomethasone Group		Beclomethasone nasal spray	Drug: Beclomethasone

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Medical Device, drug-like	Other	Ectoin Allergy Nasal Spray	Ectoin Group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Total Nasal Symptom Score		Time Frame: day 1, day 7, day 14

Secondary Outcomes

Measure	Description	Time Frame
Change in palatal itching score		Day 1, 7 and 14
Efficacy and tolerability assessment by the patients and by the investigator		day 7 and 14
Change in quality of life assessed by Rhinitis Quality of Life Questionnaire

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed allergic rhinitis during the observational period

Exclusion Criteria:

Contra indications according to the label

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Primary Care Clinic

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Uwe Sonnemann, MD	HNO Praxis Elmshorn	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D065631	Rhinitis, Allergic

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
D004864	Equipment and Supplies
D001507	Beclomethasone

Ancestor Terms

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids

Browse Leaves

Not provided

Browse Branches

Not provided