Chronic Rhinosinusitis (Diagnosis)Phase 3NCT04572516
Botulium Toxin Type A In Non Infectious Chronic Rhinosinusitis
A Phase 3 study testing BTX A Topical and BTX A Injection in people with Chronic Rhinosinusitis (Diagnosis), run by Benha University at 1 site in Egypt.
Trial summary
The present work aims to assess the effectiveness and safety of topical application of BTX - A compared with its intra turbinate injection in controlling the symptoms in non infectious chronic rhinosinusitis patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinosinusitis (Diagnosis)
- What is being tested?
- BTX A Topical and BTX A Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2020to 15 Jul 2021
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with persistent symptoms of chronic non infectious rhinosinusitis not responding to previous lines of treatment including antihistaminics ,nasal decongestant, and or nasal steroid spray will be included in this study.
Who cannot join
- Patients with major structural deformities(septal deviation , adenoid hypertrophy, nasal valve pathology or nasal polyps).
- Having systemic illness such as DM, HTN, Malignancy or Tuberculosis.
- History of nasal surgery such as turbinate reduction surgery orseptoplasty.
- Acute rhinosinusitis findings; e.g purulent or mucopurulent nasal discharge
- Radiological finding of nasal tumors or fungal sinusitis.
- Any accompanying disease such as glaucoma or prostate hypertrophy or myasthenia that might be aggravated by anticholinergic therapy .
Show all 9Show fewer
- use of systemic or local corticosteroid less than 1 month prior the study.
- Pregnancy or lactation.
- History of allergy to botox or local anesthetic agents.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Benha University Hospital, Faculty of Medicine
Banhā, Qalyubia Governorate, 13512
About this study
Official title: Topical Application Versus Intra Turbinate Injection of Botulium Toxin Type A In The Treatment of Non Infectious Chronic Rhinosinusitis
The present work aims to assess the effectiveness and safety of topical application of BTX - A compared with its intra turbinate injection in controlling the symptoms in non infectious chronic rhinosinusitis patients
Read the detailed description
A prospective comparative study will be carried out on 30 participant of both sex at Otorhinolaryngology Department, Benha University Hospital, it will include patients suffering from non infectious chronic rhinosinustitis symptoms in the form of nasal blockage, rhinorrhea, itching and/or sneezing.
The patients will be divided randomly into two groups:
- Group A (topical group) : 15 patients
- Group B (injected group) : 15 patients
All patients will be subjected to:
- Full clinical evaluation:
- Full history taking B) Clinical examination by
- anterior rhinoscopy to evaluate the nasal cavity to exclude purulent discharge , nasal polyps or anterior septal deviation.
- nasal endoscopy to exclude nasal infection signs ,nasal polyps ,the posterior septal deviation or adenoid .
- Investigations:CT nose and paranasal sinuses coronal cuts to exclude fungal sinusitis, nasal polyps or other structural abnormalities e.g; posterior septal deviation, conchae bullosa or any other nasal pathology .
- Intervention :
- BTX -A available in the Egyptian market in the form of powder vial (Allergan) containing 100 Units, will be dissolved in 10 cc saline to obtain clear colorless solution in which each 1cc contain 10 Units.
- In group A (topical group) ,topical application in the form of merocel soaked with 20 units of BTX_A (2ml) will be placed at each side of the nasal cavity for 30 minutes.
- In group B (injected group), 20 units of BTX_A (2ml) will be injected submucosally in each inferior turbinate using insulin syringe needle after local anesthesia using 10% xylocaine spray .
- Follow Up Follow up visits will be at 1,2,4,6,8 weeks, patients will be assessed and questionnaired about severity of the symptoms and possible adverse effects including epistaxis and nasal dryness .
- Conditions
- Chronic Rhinosinusitis (Diagnosis)
- Being tested
- BTX A Topical, BTX A Injection
- Keywords
- Chronic rhinosinustitis, Botulium Toxin A
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BTX A TopicalDrug
Also called Topical
In group A (topical group) ,topical application in the form of merocel soaked with 20 units of BTX_A (2ml) will be placed at each side of the nasal cavity for 30 minutes.
BTX A InjectionDrug
Also called Injection
In group B (injected group), 20 units of BTX_A(2ml) will be injected submucosally in each inferior turbinate using insulin syringe needle after local anesthesia using 10% xylocaine spray .
| Study group | Role | What they receive |
|---|---|---|
| Topical group | Experimental | Topical application in the form of merocel soaked with 20 units of BTX_A (2ml) will be placed at each side of the nasal cavity for 30 minutes. Receives: Drug: BTX A Topical |
| Injection group | Experimental | 20 units of BTX_A (2ml) will be injected submucosally in each inferior turbinate using insulin syringe needle after local anesthesia using 10% xylocaine spray . Receives: Drug: BTX A Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rhinitis symptom severity
the rhinitis symptom severity questionnaire, this is questionnaire consists of 4 items (nasal obstruction, rhinorrhea , sneezing and or nasal itching) . each symptom given score from 0 to 3 ( 0 = none, 1 = mild, 2 = moderate and 3 = severe)
Measured: 2 months
Secondary outcomes (1)
possible adverse effects
epistaxis and nasal dryness (yes/no)
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2020
- Study start1 May 2020
- Primary completion15 Jun 2021
- Study completion15 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Rhinosinusitis (Diagnosis)Studies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdelrahman Ahmed Abdelalim, Benha University
- Investigators
- Abdelrahman A Abdelalim, MD, Principal investigator, Benha UniversityMohamed A Elsayed, MD, Study chair, Benha UniversityNaslshah G Kazeem, MD, Study chair, Benha UniversityAya L Hassan, Resident, Study chair, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04572516
- Sponsor's protocol ID
- MS 3-11-2019
- Status last verified
- Jul 2021
- First submitted
- 26 Sep 2020
- Last updated
- 23 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang EZ, Tan S, Loh I. Botolinum toxin in rhinitis: Literature review and posterior nasal injection in allergic rhinitis. Laryngoscope. 2017 Nov;127(11):2447-2454. doi: 10.1002/lary.26616. Epub 2017 Jul 6.
PubMed 28681969Ozcan C, Vayisoglu Y, Dogu O, Gorur K. The effect of intranasal injection of botulinum toxin A on the symptoms of vasomotor rhinitis. Am J Otolaryngol. 2006 Sep-Oct;27(5):314-8. doi: 10.1016/j.amjoto.2006.01.008.
PubMed 16935174
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Application Versus Intra Turbinate Injection of Botulium Toxin Type A In The Treatment of Non Infectious Chronic Rhinosinusitis
- ClinicalTrials.gov ID
- NCT04572516
- Acronym / sponsor ID
- MS 3-11-2019
- Conditions
- Chronic Rhinosinusitis (Diagnosis)
- Keywords
- Chronic rhinosinustitis, Botulium Toxin A
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 1 Oct 2020 (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.
The present work aims to assess the effectiveness and safety of topical application of BTX - A compared with its intra turbinate injection in controlling the symptoms in non infectious chronic rhinosinusitis patients
Detailed description
A prospective comparative study will be carried out on 30 participant of both sex at Otorhinolaryngology Department, Benha University Hospital, it will include patients suffering from non infectious chronic rhinosinustitis symptoms in the form of nasal blockage, rhinorrhea, itching and/or sneezing.
The patients will be divided randomly into two groups:
- Group A (topical group) : 15 patients
- Group B (injected group) : 15 patients
All patients will be subjected to:
- Full clinical evaluation:
- Full history taking B) Clinical examination by
- anterior rhinoscopy to evaluate the nasal cavity to exclude purulent discharge , nasal polyps or anterior septal deviation.
- nasal endoscopy to exclude nasal infection signs ,nasal polyps ,the posterior septal deviation or adenoid .
- Investigations:CT nose and paranasal sinuses coronal cuts to exclude fungal sinusitis, nasal polyps or other structural abnormalities e.g; posterior septal deviation, conchae bullosa or any other nasal pathology .
- Intervention :
- BTX -A available in the Egyptian market in the form of powder vial (Allergan) containing 100 Units, will be dissolved in 10 cc saline to obtain clear colorless solution in which each 1cc contain 10 Units.
- In group A (topical group) ,topical application in the form of merocel soaked with 20 units of BTX_A (2ml) will be placed at each side of the nasal cavity for 30 minutes.
- In group B (injected group), 20 units of BTX_A (2ml) will be injected submucosally in each inferior turbinate using insulin syringe needle after local anesthesia using 10% xylocaine spray .
- Follow Up Follow up visits will be at 1,2,4,6,8 weeks, patients will be assessed and questionnaired about severity of the symptoms and possible adverse effects including epistaxis and nasal dryness .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical group | Experimental | Drug: BTX A TopicalTopical application in the form of merocel soaked with 20 units of BTX_A (2ml) will be placed at each side of the nasal cavity for 30 minutes. |
| Injection group | Experimental | Drug: BTX A Injection20 units of BTX_A (2ml) will be injected submucosally in each inferior turbinate using insulin syringe needle after local anesthesia using 10% xylocaine spray . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with persistent symptoms of chronic non infectious rhinosinusitis not responding to previous lines of treatment including antihistaminics ,nasal decongestant, and or nasal steroid spray will be included in this study.
Key exclusion criteria (9 listed)
- Patients with major structural deformities(septal deviation , adenoid hypertrophy, nasal valve pathology or nasal polyps).
- Having systemic illness such as DM, HTN, Malignancy or Tuberculosis.
- History of nasal surgery such as turbinate reduction surgery orseptoplasty.
- Acute rhinosinusitis findings; e.g purulent or mucopurulent nasal discharge
- Radiological finding of nasal tumors or fungal sinusitis.
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 |
|---|---|---|
| BTX A TopicalAlso: TopicalIn group A (topical group) ,topical application in the form of merocel soaked with 20 units of BTX_A (2ml) will be placed at each side of the nasal cavity for 30 minutes. | Drug | Topical group |
| BTX A InjectionAlso: InjectionIn group B (injected group), 20 units of BTX_A(2ml) will be injected submucosally in each inferior turbinate using insulin syringe needle after local anesthesia using 10% xylocaine spray . | Drug | Injection group |
Primary outcome
the rhinitis symptom severity
Time frame: 2 months
the rhinitis symptom severity questionnaire, this is questionnaire consists of 4 items (nasal obstruction, rhinorrhea , sneezing and or nasal itching) . each symptom given score from 0 to 3 ( 0 = none, 1 = mild, 2 = moderate and 3 = severe)
1 secondary outcome
possible adverse effects
Time frame: 2 months
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 23 Jul 2021.
- Background: PubMed 28681969Zhang EZ, Tan S, Loh I. Botolinum toxin in rhinitis: Literature review and posterior nasal injection in allergic rhinitis. Laryngoscope. 2017 Nov;127(11):2447-2454. doi: 10.1002/lary.26616. Epub 2017 Jul 6.
- Background: PubMed 16935174Ozcan C, Vayisoglu Y, Dogu O, Gorur K. The effect of intranasal injection of botulinum toxin A on the symptoms of vasomotor rhinitis. Am J Otolaryngol. 2006 Sep-Oct;27(5):314-8. doi: 10.1016/j.amjoto.2006.01.008.
- Individual participant dataSharing planned: No
Related trials for Chronic Rhinosinusitis (Diagnosis)
RecruitingObservational study
Establishing Personalized Phage Therapy and Its Comparative Cost in Difficult-to-treat Infections (EPHICACI)
Musculoskeletal Infection, Chronic Rhinosinusitis (Diagnosis)
RecruitingObservational study
Impact of Sinus Surgery on Individuals With Cystic Fibrosis
Chronic Rhinosinusitis (Diagnosis), Cystic Fibrosis
RecruitingObservational study
Sinus Disease in Young Children With Cystic Fibrosis
Cystic Fibrosis in Children, Cystic Fibrosis
RecruitingPhase 2
Topical Probiotic Sinus Irrigations for Treating Chronic Sinusitis
Chronic Rhinosinusitis (Diagnosis)
Enrolling by invitation
Xylitol vs Saline Nasal Irrigations in CF-CRS
Chronic Rhinosinusitis (Diagnosis)
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.
Abdelrahman A Abdelalim, MD principal investigator
Benha University
Mohamed A Elsayed, MD study chair
Benha University
Naslshah G Kazeem, MD study chair
Benha University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BTX A Topical and BTX A Injection in people with Chronic Rhinosinusitis (Diagnosis), run by Benha University at 1 site in Egypt.
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 1 inclusion and 9 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 23 Jul 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 Egypt. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
the rhinitis symptom severity (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04572516, which also lists 2 linked publications.
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 23 Jul 2021; AzTrials last refreshed its copy on 26 Oct 2026.