Effect of Hypertonic Solutions on Allergic Rhinitis Patients | NCT02233426

Studies
Effect of Hypertonic Solutions on Allergic Rhinitis Patients

NCT02233426

Sponsor

Namik Kemal University

Status

Unknown status

Last Update Posted

Sep 8, 2014Estimated

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Allergic Rhinitis

Interventions

Not provided

Countries

Turkey (Türkiye)

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

Sep 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2014

Primary Completion Date

Oct 2014Estimated

Completion Date

Oct 2014Estimated

First Submitted Date

Aug 29, 2014

First Submission Date that Met QC Criteria

Sep 3, 2014

First Posted Date

Sep 8, 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

Sep 3, 2014

Last Update Posted Date

Sep 8, 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

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.

Detailed Description

The medical records of the patients who admitted to outpatient clinic of otorhinolaryngology department of a tertiary referral center were retrospectively investigated. The symptom scores and nasal eosinophil levels of the patients were recorded. Patients using hypertonic solutions alone or steroid nasal spray alone were compared.

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

1,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Sinonasal Outcome Test (SNOT-22) questionairre scores		SNOT-22 scores obtained before the treatment and after the first month of treatment would be recorded

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zafer Ciftci, Assist. Prof	Contact	00905325540605		zaferciftci@yahoo.com

Overall Officials

Name	Affiliation	Role
Zafer Ciftci, Assist. Prof	Namik Kemal University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Namik Kemal University, Department of Otorhinolaryngology		Tekirdağ		59100	Turkey (Türkiye)

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