NCT02133053

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2011

Shorter than P25 for all trials

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

Study Start

First participant enrolled

May 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 7, 2014

Completed
Last Updated

May 7, 2014

Status Verified

May 1, 2014

Enrollment Period

2 months

First QC Date

May 2, 2014

Last Update Submit

May 6, 2014

Conditions

Allergic Rhinitis

Keywords

Allergic RhinitisEctoinebitopEctoin

Outcome Measures

Primary Outcomes (1)

  • Change in Total Nasal Symptom Score

    Time Frame: day 1, day 7, day 14

Secondary Outcomes (3)

  • 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

    Day1 and Day 14

Study Arms (2)

Ectoin Group

Ectoin Allergy Nasal Spray (Medical Device, drug-like)

Other: Medical Device, drug-like

Beclomethasone Group

Beclomethasone nasal spray

Drug: Beclomethasone

Interventions

Medical Device, drug-likeOTHER

Ectoin Allergy Nasal Spray

Ectoin Group
BeclomethasoneDRUG

Beclomethasone nasal spray

Beclomethasone Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary Care Clinic

You may qualify if:

  • Diagnosed allergic rhinitis during the observational period

You may not qualify if:

  • Contra indications according to the label

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Equipment and SuppliesBeclomethasone

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Chlorinated

Study Officials

  • Uwe Sonnemann, MD

    HNO Praxis Elmshorn

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2014

First Posted

May 7, 2014

Study Start

May 1, 2011

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

May 7, 2014

Record last verified: 2014-05