Allergic RhinitisNCT04871256
Effects of Septorhinoplasty on Allergic Rhinitis
A study testing Septorhinoplasty in people with Allergic Rhinitis, run by Mario Pérez Sayáns at 1 site in Spain.
Trial summary
Allergic rhinitis (AR) is a chronic inflammatory disease that affects almost 30% of adult population. Some patients associate septal deviation, main cause of chronic nasal obstruction, and AR. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Rhinitis
- What is being tested?
- Septorhinoplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2021to 1 Mar 2021
- Phase
- Interventional
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Allergic Rhinitis
- Diagnosis of nasal obstruction with septal deviation
Who cannot join
- Previous nasal surgery
- Smokers
- Chronic obstructive pulmonary disease
- Psychiatric disorders
- Malignant tumors
- Severe hepatopathy
- Obstructive sleep apnea
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Septorhinoplasty on Allergic Rhinitis Evolution
Allergic rhinitis (AR) is a chronic inflammatory disease that affects almost 30% of adult population. Some patients associate septal deviation, main cause of chronic nasal obstruction, and AR. Current literature about AR treatment with septoplasty (STP) is still contradictory, because is thought that patients with AR are not able to appreciate improvement after surgery.
Patients diagnosed with allergic rinitis and septal deviation were evaluated to determined life quality and airflow obstruction evolution after STP.
Read the detailed description
This is a prospective quasi experimental study. After being informed about the study, patients that signed written informed consent were included in the study. In week 0 before surgery, all measurements and questionnaires were performed. 1 month after surgery, measurements were repeated.
After screening, patient´s obstruction was evaluated by anterior rhinomanometry (RNMa), and quality of life scored through ESPRINT scale. ESPRINT is a validated Spanish questionnaire about daily life activity, sleep, psycology and perception of affection by allergic rhinitis. Symtoms were evaluated with visual analogue scale (VAS) and clinical history. Symptoms like sneezing, itchy nose, ocular symptoms and/or nasal obstruction. Also medication (intranasal corticosteroid, antileucotrienos, antihistamines eye drops , antishistamines) frequency use was registered.
- Conditions
- Allergic Rhinitis
- Being tested
- Septorhinoplasty
- Keywords
- Septoplasty, VAS, quality of life, allergic rhinitis, nasal obstruction
- Medical subject headings
- Rhinitis, Allergic, Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SeptorhinoplastyProcedure or surgery
This intervention will be performed by the same surgeon, after signing of patient inform consent.
| Study group | Role | What they receive |
|---|---|---|
| Inver | Experimental | Intervention: after screening, patient´s obstruction will be evaluated by anterior rhinomanometry (RNMa), and quality of life wil be scored through ESPRINT scale. ESPRINT is a validated Spanish questionnaire about daily life activity, sleep, psychology and perception of affection by allergic rhinitis.
Symptoms will be evaluated with visual analogue scale (VAS) and clinical history. Symptoms like sneezing, itchy nose, ocular symptoms and/or nasal obstruction. Also medication (intranasal corticosteroid, antileukotrienes, antihistamine eye drops, antihistamine) frequency use will be registered Receives: Procedure: Septorhinoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline of Airflow rate
Rhinomanometre will be used to determine airflow rate changes before surgery (septoplasty) and after it. Rhinomanometre will determine airflow rate in cm3/s and also use a quality scale as normal, mild, severe and very severe
Measured: Change from baseline airflow rate (Before treatment) at 1 month after surgery
Secondary outcomes (2)
Changes from baseline of symptoms
VAS score. VAS: visual analogue scale. Patients determine their symptoms with a visual scale that range from 0-10.
Measured: Changes from baseline (Before treatment) at 1 month after surgery
Changes from baseline in quality of life
ESPRINT questionnaire. This is a validated spanish questionnaire about daily life impairments with 28 items.
Measured: Changes from baseline (Before treatment) at 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start1 Jan 2021
- Primary completion1 Mar 2021
- Study completion1 Mar 2021
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A prospective study with 1 months period follow up. Patients with septal deviation and allergic rhinitis diagnosis will be included. Obstruction airflow will be evaluated before and after surgery with rhinomanometry (RNM). Life quality will be assessed with VAS and ESPRINTquestionnaires.
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mario Pérez Sayáns
- Sponsor type
- University, hospital or other
- Collaborators
- Universidade da Coruña
- Responsible party
- Sponsor-investigator, Mario Pérez Sayáns, University of Santiago de Compostela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04871256
- Sponsor's protocol ID
- AR/STP-UDC
- Status last verified
- Apr 2021
- First submitted
- 14 Jan 2021
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Results will be shared by articles publication.
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Septorhinoplasty on Allergic Rhinitis Evolution
- ClinicalTrials.gov ID
- NCT04871256
- Acronym / sponsor ID
- AR/STP-UDC
- Conditions
- Allergic Rhinitis
- Keywords
- Septoplasty, VAS, quality of life, allergic rhinitis, nasal obstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Mario Pérez SayánsUniversity, hospital or other
- Collaborators
- Universidade da Coruña
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 4 May 2021 (actual)
- 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.
Allergic rhinitis (AR) is a chronic inflammatory disease that affects almost 30% of adult population. Some patients associate septal deviation, main cause of chronic nasal obstruction, and AR. Current literature about AR treatment with septoplasty (STP) is still contradictory, because is thought that patients with AR are not able to appreciate improvement after surgery.
Patients diagnosed with allergic rinitis and septal deviation were evaluated to determined life quality and airflow obstruction evolution after STP.
Detailed description
This is a prospective quasi experimental study. After being informed about the study, patients that signed written informed consent were included in the study. In week 0 before surgery, all measurements and questionnaires were performed. 1 month after surgery, measurements were repeated.
After screening, patient´s obstruction was evaluated by anterior rhinomanometry (RNMa), and quality of life scored through ESPRINT scale. ESPRINT is a validated Spanish questionnaire about daily life activity, sleep, psycology and perception of affection by allergic rhinitis. Symtoms were evaluated with visual analogue scale (VAS) and clinical history. Symptoms like sneezing, itchy nose, ocular symptoms and/or nasal obstruction. Also medication (intranasal corticosteroid, antileucotrienos, antihistamines eye drops , antishistamines) frequency use was registered.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A prospective study with 1 months period follow up. Patients with septal deviation and allergic rhinitis diagnosis will be included. Obstruction airflow will be evaluated before and after surgery with rhinomanometry (RNM). Life quality will be assessed with VAS and ESPRINTquestionnaires.
| Arm | Type | Receives |
|---|---|---|
| Inver | Experimental | Procedure: SeptorhinoplastyIntervention: after screening, patient´s obstruction will be evaluated by anterior rhinomanometry (RNMa), and quality of life wil be scored through ESPRINT scale. ESPRINT is a validated Spanish questionnaire about daily life activity, sleep, psychology and perception of affection by allergic rhinitis. Symptoms will be evaluated with visual analogue scale (VAS) and clinical history. Symptoms like sneezing, itchy nose, ocular symptoms and/or nasal obstruction. Also medication (intranasal corticosteroid, antileukotrienes, antihistamine eye drops, antihistamine) frequency use will be registered |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of Allergic Rhinitis
- Diagnosis of nasal obstruction with septal deviation
Key exclusion criteria (7 listed)
- Previous nasal surgery
- Smokers
- Chronic obstructive pulmonary disease
- Psychiatric disorders
- Malignant tumors
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SeptorhinoplastyThis intervention will be performed by the same surgeon, after signing of patient inform consent. | Procedure or surgery | Inver |
Primary outcome
Changes from baseline of Airflow rate
Time frame: Change from baseline airflow rate (Before treatment) at 1 month after surgery
Rhinomanometre will be used to determine airflow rate changes before surgery (septoplasty) and after it. Rhinomanometre will determine airflow rate in cm3/s and also use a quality scale as normal, mild, severe and very severe
2 secondary outcomes
Changes from baseline of symptoms
Time frame: Changes from baseline (Before treatment) at 1 month after surgery
Changes from baseline in quality of life
Time frame: Changes from baseline (Before treatment) at 1 month after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
- Individual participant dataSharing planned: No. Results will be shared by articles publication.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Septorhinoplasty in people with Allergic Rhinitis, run by Mario Pérez Sayáns at 1 site in Spain.
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 2 inclusion and 7 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: finished, as of the sponsor's last update on 4 May 2021. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline of Airflow rate (time frame: Change from baseline airflow rate (Before treatment) at 1 month after surgery). 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 4 May 2021.