Allergic RhinitishypertonicNCT02233426
Effect of Hypertonic Solutions on Allergic Rhinitis Patients
An observational study of Allergic Rhinitis, run by Namik Kemal University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Allergic Rhinitis
- How many people
- 1,000 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Sep 2014to Oct 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Medical records of patients who admitted to the outpatient clinic of a tertiary referral center was enrolled.
Who may be able to join
- 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
Who cannot join
- Patients with a history of asthma, urticeria, eczama, diabetes mellitus, hypertension, COPD and other systemic diseases were excluded
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Namik Kemal University, Department of Otorhinolaryngology
Tekirdağ, 59100
Zafer Ciftci, Assist. Prof
Zafer Ciftci, Assist. Prof
About this study
Official title: Do Hypertonic Solutions Have an Impact on Nasal Eosinophilia in Allergic Rhinitis Patients?
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.
Read the 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.
- Conditions
- Allergic Rhinitis
- Keywords
- allergic rhinitis, nasal steroid, hypertonic saline, eosinophil, symptom score
- Medical subject headings
- Rhinitis, Allergic
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of eosinophils in nasal secretions
Measured: 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
Measured: SNOT-22 scores obtained before the treatment and after the first month of treatment would be recorded
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionOct 2014 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Namik Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zafer Ciftci, Namik Kemal University
- Investigators
- Zafer Ciftci, Assist. Prof, Principal investigator, Namik Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02233426
- Sponsor's protocol ID
- NKU-001
- Acronym
- hypertonic
- Status last verified
- Sep 2014
- First submitted
- 29 Aug 2014
- Last updated
- 8 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Hypertonic Solutions Have an Impact on Nasal Eosinophilia in Allergic Rhinitis Patients?
- ClinicalTrials.gov ID
- NCT02233426
- Acronym / sponsor ID
- hypertonic / NKU-001
- Conditions
- Allergic Rhinitis
- Keywords
- allergic rhinitis, nasal steroid, hypertonic saline, eosinophil, symptom score
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Namik Kemal UniversityUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Oct 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 8 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Medical records of patients who admitted to the outpatient clinic of a tertiary referral center was enrolled.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with a history of asthma, urticeria, eczama, diabetes mellitus, hypertension, COPD and other systemic diseases were excluded
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The number of eosinophils in nasal secretions
Time frame: The number of eosinophils in nasal secretions that was counted before the therapy and after the first month of therapy would be recorded
1 secondary outcome
Sinonasal Outcome Test (SNOT-22) questionairre scores
Time frame: SNOT-22 scores obtained before the treatment and after the first month of treatment would be recorded
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2014.
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Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zafer Ciftci, Assist. Prof principal investigator
Namik Kemal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergic Rhinitis, run by Namik Kemal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zafer Ciftci, Assist. Prof (00905325540605, zaferciftci@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of eosinophils in nasal secretions (time frame: The number of eosinophils in nasal secretions that was counted before the therapy and after the first month of therapy would be recorded). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2014.