NCT02233426

Brief Summary

The purpose of this study is to assess the effectivity of using hypertonic nasal solutions alone on the symptom scores and nasal eosinophil levels of allergic rhinitis patients, retrospectively.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

August 29, 2014

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 8, 2014

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

September 8, 2014

Status Verified

September 1, 2014

Enrollment Period

1 month

First QC Date

August 29, 2014

Last Update Submit

September 3, 2014

Conditions

Allergic Rhinitis

Keywords

allergic rhinitisnasal steroidhypertonic salineeosinophilsymptom score

Outcome Measures

Primary Outcomes (1)

  • The number of eosinophils in nasal secretions

    The number of eosinophils in nasal secretions that was counted before the therapy and after the first month of therapy would be recorded

Secondary Outcomes (1)

  • Sinonasal Outcome Test (SNOT-22) questionairre scores

    SNOT-22 scores obtained before the treatment and after the first month of treatment would be recorded

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Medical records of patients who admitted to the outpatient clinic of a tertiary referral center was enrolled.

You may qualify if:

  • Patients with positive Prick's test to at least one allergen and diagnosed as having allergic rhinitis were included
  • Patients who used hypertonic nasal solution alone for at least one month were included as sthe study group
  • Patients who used nasal steroid spray alone or at least one month were included as sthe study group

You may not qualify if:

  • Patients with a history of asthma, urticeria, eczama, diabetes mellitus, hypertension, COPD and other systemic diseases were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Namik Kemal University, Department of Otorhinolaryngology

Tekirdağ, 59100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

RhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Zafer Ciftci, Assist. Prof

    Namik Kemal University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zafer Ciftci, Assist. Prof

CONTACT

00905325540605zaferciftci@yahoo.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof., M.D.

Study Record Dates

First Submitted

August 29, 2014

First Posted

September 8, 2014

Study Start

September 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

September 8, 2014

Record last verified: 2014-09

Locations

TU(1)