Shellfish HypersensitivityPhase 4NCT05343650
NOVAPAK Nasal Packing in Shellfish Allergic Patients
A Phase 4 study testing NOVAPAK nasal packing applied to forearm and NOVAPAK nasal packing applied to nasal cavity in people with Shellfish Hypersensitivity and Epistaxis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
NOVAPAK is a sponge-like material made from materials found in shellfish. It is commonly used after nasal surgery or in nasal bleeding, as it promotes healing, decreases bleeding, and has antibacterial properties. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Shellfish Hypersensitivity, Epistaxis
- What is being tested?
- NOVAPAK nasal packing applied to forearm and NOVAPAK nasal packing applied to nasal cavity
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 15 Mar 2024to 15 May 2025
- Phase
- Phase 4
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged 18-60
- Positive history of shellfish allergy
- Confirmation of allergy via previous reaction during oral challenge or convincing clinical history and testing.
Who cannot join
- Severe lung diseases: severe asthma, obstructive lung disease
- Severe cardiovascular disease: history of congestive heart failure, myocardial infarction, valvulopathy, or unstable tachy-or-bradyarrhythmia.
- Severe cerebrovascular disease: history of stroke or severe carotid stenosis.
- Presence of beta-blocker mediations.
- Patients unable to discontinue antihistamine medications or prednisone.
- Patients with severe or refractory anaphylaxis during prior oral challenge to shellfish, or those with documented systemic mastocytosis.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: NOVAPAK Nasal Packing: Safety Study in Shellfish Allergic Patients
NOVAPAK is a sponge-like material made from materials found in shellfish. It is commonly used after nasal surgery or in nasal bleeding, as it promotes healing, decreases bleeding, and has antibacterial properties. Although NOVOPAK does not contain proteins or compounds known to be responsible for allergic reactions in people with a known allergy to shellfish, out of an abundance of caution, the manufacturer (Medtronic) has recommended avoidance in those with known shellfish allergy. There have been no reported allergic reactions in patients with shellfish allergy who were given chitosan bandages in emergencies (e.g. military applications). The study aims to investigate the safety of its use in patients with known shellfish allergy to improve healthcare quality and patient care support.
Read the detailed description
This is a prospective interventional study to assess whether the tested product triggers an allergic reaction in patients with known-shellfish allergies.
The primary objective is to assess the safety of Novapak, a chitosan-containing nasal packing material, in patients with known shellfish allergy.
The study will be conducted in two phases. First, participants will undergo an allergy test - Skin prick test (SPT) to crab, lobster, shrimp, oyster, clam, scallop, squid, and octopus -, and antibody levels analysis. Second, in a controlled setting (i.e., in a hospital clinic that includes a resuscitation cart and doctors monitoring - allergist and otolaryngologist), Novapak packing will be applied to the patient's skin for 30 minutes (on the anterior aspect of the patients' non-dominant arm). Then, provided that no allergic symptoms are observed in stage 1, the patient's nose will be anesthetized with topical lidocaine, and a piece of Novapak material will be applied to the participant's nasal cavity at the level of the inferior turbinate for 15 minutes. After removal, the participant will be monitored in the clinic for an hour. Any allergic reaction will be documented, including increased nasal congestion, rhinorrhea, or pruritis.
Since Novapak contains purified chitosan, the investigators hypothesizes that no allergic reactions will be demonstrated.
- Conditions
- Shellfish Hypersensitivity, Epistaxis
- Being tested
- NOVAPAK nasal packing applied to forearm, NOVAPAK nasal packing applied to nasal cavity
- Keywords
- nasal bleedings, Post-surgical healing, chitosan-based films
- Medical subject headings
- Shellfish Hypersensitivity, Epistaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NOVAPAK nasal packing applied to forearmDevice
Novapak packing will be applied to the patient's skin for 30 minutes on the anterior aspect of the patients' non-dominant arm. In case of pre-existing wounds, it will be applied to the other forearm.
NOVAPAK nasal packing applied to nasal cavityDevice
A piece of Novapak material will be applied to the participant's nasal cavity at the level of the inferior turbinate for 15 minutes
| Study group | Role | What they receive |
|---|---|---|
| Study arm | Experimental | Stage 1 After shellfish allergy is confirmed through the skin prick test and IgE analysis, Novapak packing will be applied to the patient's skin for 30 minutes on the anterior aspect of the patients' non-dominant arm. In case of pre-existing wounds, it will be applied to the other forearm. Participants will then be monitored for 1 hour, and any- reaction will be documented. In case of any symptoms of an allergic reaction, their study participation will be terminated.
Stage 2 If no allergic symptoms are observed in stage 1, the patient's nose will be anesthetized with topical lidocaine. A piece of Novapak material will be applied to the participant's nasal cavity at the level of the inferior turbinate for 15 minutes. After removal, the participant will be monitored in the clinic for an hour. Any allergic reaction will be documented, including increased nasal congestion, rhinorrhea, or pruritis. Receives: Device: NOVAPAK nasal packing applied to forearm; Device: NOVAPAK nasal packing applied to nasal cavity |
What is being measured
The primary outcome is the main question the study is designed to answer.
First stage - Skin test
The occurrence of an Allergic reaction to Novapak packing in the anterior aspect of the patients' non-dominant arm will be tested.
Measured: Until one hour after the test.
Second stage - Novapak in the nasal cavity (1 hour)
The occurrence of Allergic reaction to Novapak packing on the participant's nasal cavity at the level of the inferior turbinate.
Measured: Until one hour after the test
Second stage - Novapak in the nasal cavity (48 hours)
The occurrence of Allergic reaction to Novapak packing on the participant's nasal cavity at the level of the inferior turbinate.
Measured: 48 hours after the test.
Secondary outcomes (2)
Change in Nasal congestion score - (1 hour)
Change on the nasal congestion score 1 hour after the provocation challenge in the nose using NOVAPAK 0 =No congestion
- =Mild congestion
- =Moderate congestion
- =Severe congestion
Measured: Baseline, 1 hour after the provocation challenge.
Change in Nasal congestion score - (48 hours)
Change on the nasal congestion score 48 hours after the provocation challenge in the nose using NOVAPAK 0 =No congestion
- =Mild congestion
- =Moderate congestion
- =Severe congestion
Measured: Baseline, 48 hours after the provocation challenge.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2022
- Study start15 Mar 2024 (estimated)
- Primary completion24 Dec 2024 (estimated)
- Study completion15 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Shellfish HypersensitivityStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective interventional study
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05343650
- Sponsor's protocol ID
- ReDA 12329
- Status last verified
- Sep 2023
- First submitted
- 5 Apr 2022
- Last updated
- 11 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kurita K. Chitin and chitosan: functional biopolymers from marine crustaceans. Mar Biotechnol (NY). 2006 May-Jun;8(3):203-26. doi: 10.1007/s10126-005-0097-5. Epub 2006 Mar 17.
PubMed 16532368Chou TC, Fu E, Wu CJ, Yeh JH. Chitosan enhances platelet adhesion and aggregation. Biochem Biophys Res Commun. 2003 Mar 14;302(3):480-3. doi: 10.1016/s0006-291x(03)00173-6.
PubMed 12615058Rao SB, Sharma CP. Use of chitosan as a biomaterial: studies on its safety and hemostatic potential. J Biomed Mater Res. 1997 Jan;34(1):21-8. doi: 10.1002/(sici)1097-4636(199701)34:13.0.co;2-p.
PubMed 8978649Winebrake JP, Mahrous A, Kacker A, Tabaee A, Levinger JI, Pearlman AN, Stewart MG, Lelli GJ Jr. Postoperative Bioresorbable Chitosan-Based Dressing for Endoscopic Middle Meatal Dacryocystorhinostomy With Balloon Dilation. Ear Nose Throat J. 2021 Jul;100(6):425-429. doi: 10.1177/0145561319866822. Epub 2019 Sep 26.
PubMed 31558059Zhou JC, Zhang JJ, Zhang W, Ke ZY, Zhang B. Efficacy of chitosan dressing on endoscopic sinus surgery: a systematic review and meta-analysis. Eur Arch Otorhinolaryngol. 2017 Sep;274(9):3269-3274. doi: 10.1007/s00405-017-4584-x. Epub 2017 Apr 29.
PubMed 28456847Kourelis K, Shikani AH. Effectiveness of chitosan-based packing in 35 patients with recalcitrant epistaxis in the context of coagulopathy. Clin Otolaryngol. 2012 Aug;37(4):309-13. doi: 10.1111/j.1749-4486.2012.02488.x. No abstract available.
PubMed 22925096Valentine R, Athanasiadis T, Moratti S, Hanton L, Robinson S, Wormald PJ. The efficacy of a novel chitosan gel on hemostasis and wound healing after endoscopic sinus surgery. Am J Rhinol Allergy. 2010 Jan-Feb;24(1):70-5. doi: 10.2500/ajra.2010.24.3422.
PubMed 20109331HemCon® Bandage PRO - Tricol Biomedical [Internet]. [cited 2021 Dec 28]. Available from: https://tricolbiomedical.com/product/hemcon-bandage-pro/
Waibel KH, Haney B, Moore M, Whisman B, Gomez R. Safety of chitosan bandages in shellfish allergic patients. Mil Med. 2011 Oct;176(10):1153-6. doi: 10.7205/milmed-d-11-00150.
PubMed 22128651Amaral L, Silva D, Couto M, Nunes C, Rocha SM, Coimbra MA, Coimbra A, Moreira A. Safety of chitosan processed wine in shrimp allergic patients. Ann Allergy Asthma Immunol. 2016 May;116(5):462-3. doi: 10.1016/j.anai.2016.02.004. Epub 2016 Mar 19. No abstract available.
PubMed 27009439Sicherer SH, Munoz-Furlong A, Sampson HA. Prevalence of seafood allergy in the United States determined by a random telephone survey. J Allergy Clin Immunol. 2004 Jul;114(1):159-65. doi: 10.1016/j.jaci.2004.04.018.
PubMed 15241360Moonesinghe H, Mackenzie H, Venter C, Kilburn S, Turner P, Weir K, Dean T. Prevalence of fish and shellfish allergy: A systematic review. Ann Allergy Asthma Immunol. 2016 Sep;117(3):264-272.e4. doi: 10.1016/j.anai.2016.07.015.
PubMed 27613460Lopata AL, Jeebhay MF. Airborne seafood allergens as a cause of occupational allergy and asthma. Curr Allergy Asthma Rep. 2013 Jun;13(3):288-97. doi: 10.1007/s11882-013-0347-y.
PubMed 23575656Gelis S, Rueda M, Pascal M, Fernandez-Caldas E, Fernandez EA, Araujo-Sanchez G, Bartra J, Valero A. Usefulness of the Nasal Allergen Provocation Test in the Diagnosis of Shellfish Allergy. J Investig Allergol Clin Immunol. 2022 Dec 15;32(6):460-470. doi: 10.18176/jiaci.0736. Epub 2022 Sep 7.
PubMed 34489219
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NOVAPAK Nasal Packing: Safety Study in Shellfish Allergic Patients
- ClinicalTrials.gov ID
- NCT05343650
- Acronym / sponsor ID
- ReDA 12329
- Conditions
- Shellfish Hypersensitivity, Epistaxis
- Keywords
- nasal bleedings, Post-surgical healing, chitosan-based films
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 15 Mar 2024 (estimated)
- Primary completion
- 24 Dec 2024 (estimated)
- Study completion
- 15 May 2025 (estimated)
- First posted
- 25 Apr 2022 (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.
NOVAPAK is a sponge-like material made from materials found in shellfish. It is commonly used after nasal surgery or in nasal bleeding, as it promotes healing, decreases bleeding, and has antibacterial properties. Although NOVOPAK does not contain proteins or compounds known to be responsible for allergic reactions in people with a known allergy to shellfish, out of an abundance of caution, the manufacturer (Medtronic) has recommended avoidance in those with known shellfish allergy. There have been no reported allergic reactions in patients with shellfish allergy who were given chitosan bandages in emergencies (e.g. military applications). The study aims to investigate the safety of its use in patients with known shellfish allergy to improve healthcare quality and patient care support.
Detailed description
This is a prospective interventional study to assess whether the tested product triggers an allergic reaction in patients with known-shellfish allergies.
The primary objective is to assess the safety of Novapak, a chitosan-containing nasal packing material, in patients with known shellfish allergy.
The study will be conducted in two phases. First, participants will undergo an allergy test - Skin prick test (SPT) to crab, lobster, shrimp, oyster, clam, scallop, squid, and octopus -, and antibody levels analysis. Second, in a controlled setting (i.e., in a hospital clinic that includes a resuscitation cart and doctors monitoring - allergist and otolaryngologist), Novapak packing will be applied to the patient's skin for 30 minutes (on the anterior aspect of the patients' non-dominant arm). Then, provided that no allergic symptoms are observed in stage 1, the patient's nose will be anesthetized with topical lidocaine, and a piece of Novapak material will be applied to the participant's nasal cavity at the level of the inferior turbinate for 15 minutes. After removal, the participant will be monitored in the clinic for an hour. Any allergic reaction will be documented, including increased nasal congestion, rhinorrhea, or pruritis.
Since Novapak contains purified chitosan, the investigators hypothesizes that no allergic reactions will be demonstrated.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective interventional study
| Arm | Type | Receives |
|---|---|---|
| Study arm | Experimental | Device: NOVAPAK nasal packing applied to forearm, Device: NOVAPAK nasal packing applied to nasal cavityStage 1 After shellfish allergy is confirmed through the skin prick test and IgE analysis, Novapak packing will be applied to the patient's skin for 30 minutes on the anterior aspect of the patients' non-dominant arm. In case of pre-existing wounds, it will be applied to the other forearm. Participants will then be monitored for 1 hour, and any- reaction will be documented. In case of any symptoms of an allergic reaction, their study participation will be terminated. Stage 2 If no allergic symptoms are observed in stage 1, the patient's nose will be anesthetized with topical lidocaine. A piece of Novapak material will be applied to the participant's nasal cavity at the level of the inferior turbinate for 15 minutes. After removal, the participant will be monitored in the clinic for an hour. Any allergic reaction will be documented, including increased nasal congestion, rhinorrhea, or pruritis. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adults aged 18-60
- Positive history of shellfish allergy
- Confirmation of allergy via previous reaction during oral challenge or convincing clinical history and testing.
Key exclusion criteria (7 listed)
- Severe lung diseases: severe asthma, obstructive lung disease
- Severe cardiovascular disease: history of congestive heart failure, myocardial infarction, valvulopathy, or unstable tachy-or-bradyarrhythmia.
- Severe cerebrovascular disease: history of stroke or severe carotid stenosis.
- Presence of beta-blocker mediations.
- Patients unable to discontinue antihistamine medications or prednisone.
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 |
|---|---|---|
| NOVAPAK nasal packing applied to forearmNovapak packing will be applied to the patient's skin for 30 minutes on the anterior aspect of the patients' non-dominant arm. In case of pre-existing wounds, it will be applied to the other forearm. | Device | Study arm |
| NOVAPAK nasal packing applied to nasal cavityA piece of Novapak material will be applied to the participant's nasal cavity at the level of the inferior turbinate for 15 minutes | Device | Study arm |
Primary outcome
First stage - Skin test
Time frame: Until one hour after the test.
The occurrence of an Allergic reaction to Novapak packing in the anterior aspect of the patients' non-dominant arm will be tested.
Second stage - Novapak in the nasal cavity (1 hour)
Time frame: Until one hour after the test
The occurrence of Allergic reaction to Novapak packing on the participant's nasal cavity at the level of the inferior turbinate.
Second stage - Novapak in the nasal cavity (48 hours)
Time frame: 48 hours after the test.
The occurrence of Allergic reaction to Novapak packing on the participant's nasal cavity at the level of the inferior turbinate.
2 secondary outcomes
Change in Nasal congestion score - (1 hour)
Time frame: Baseline, 1 hour after the provocation challenge.
Change in Nasal congestion score - (48 hours)
Time frame: Baseline, 48 hours after the provocation challenge.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Background: PubMed 16532368Kurita K. Chitin and chitosan: functional biopolymers from marine crustaceans. Mar Biotechnol (NY). 2006 May-Jun;8(3):203-26. doi: 10.1007/s10126-005-0097-5. Epub 2006 Mar 17.
- Background: PubMed 12615058Chou TC, Fu E, Wu CJ, Yeh JH. Chitosan enhances platelet adhesion and aggregation. Biochem Biophys Res Commun. 2003 Mar 14;302(3):480-3. doi: 10.1016/s0006-291x(03)00173-6.
- Background: PubMed 8978649Rao SB, Sharma CP. Use of chitosan as a biomaterial: studies on its safety and hemostatic potential. J Biomed Mater Res. 1997 Jan;34(1):21-8. doi: 10.1002/(sici)1097-4636(199701)34:13.0.co;2-p.
- Background: PubMed 31558059Winebrake JP, Mahrous A, Kacker A, Tabaee A, Levinger JI, Pearlman AN, Stewart MG, Lelli GJ Jr. Postoperative Bioresorbable Chitosan-Based Dressing for Endoscopic Middle Meatal Dacryocystorhinostomy With Balloon Dilation. Ear Nose Throat J. 2021 Jul;100(6):425-429. doi: 10.1177/0145561319866822. Epub 2019 Sep 26.
- Background: PubMed 28456847Zhou JC, Zhang JJ, Zhang W, Ke ZY, Zhang B. Efficacy of chitosan dressing on endoscopic sinus surgery: a systematic review and meta-analysis. Eur Arch Otorhinolaryngol. 2017 Sep;274(9):3269-3274. doi: 10.1007/s00405-017-4584-x. Epub 2017 Apr 29.
- Background: PubMed 22925096Kourelis K, Shikani AH. Effectiveness of chitosan-based packing in 35 patients with recalcitrant epistaxis in the context of coagulopathy. Clin Otolaryngol. 2012 Aug;37(4):309-13. doi: 10.1111/j.1749-4486.2012.02488.x. No abstract available.
- Background: PubMed 20109331Valentine R, Athanasiadis T, Moratti S, Hanton L, Robinson S, Wormald PJ. The efficacy of a novel chitosan gel on hemostasis and wound healing after endoscopic sinus surgery. Am J Rhinol Allergy. 2010 Jan-Feb;24(1):70-5. doi: 10.2500/ajra.2010.24.3422.
- BackgroundHemCon® Bandage PRO - Tricol Biomedical [Internet]. [cited 2021 Dec 28]. Available from: https://tricolbiomedical.com/product/hemcon-bandage-pro/
- Background: PubMed 22128651Waibel KH, Haney B, Moore M, Whisman B, Gomez R. Safety of chitosan bandages in shellfish allergic patients. Mil Med. 2011 Oct;176(10):1153-6. doi: 10.7205/milmed-d-11-00150.
- Background: PubMed 27009439Amaral L, Silva D, Couto M, Nunes C, Rocha SM, Coimbra MA, Coimbra A, Moreira A. Safety of chitosan processed wine in shrimp allergic patients. Ann Allergy Asthma Immunol. 2016 May;116(5):462-3. doi: 10.1016/j.anai.2016.02.004. Epub 2016 Mar 19. No abstract available.
- Background: PubMed 15241360Sicherer SH, Munoz-Furlong A, Sampson HA. Prevalence of seafood allergy in the United States determined by a random telephone survey. J Allergy Clin Immunol. 2004 Jul;114(1):159-65. doi: 10.1016/j.jaci.2004.04.018.
- Background: PubMed 27613460Moonesinghe H, Mackenzie H, Venter C, Kilburn S, Turner P, Weir K, Dean T. Prevalence of fish and shellfish allergy: A systematic review. Ann Allergy Asthma Immunol. 2016 Sep;117(3):264-272.e4. doi: 10.1016/j.anai.2016.07.015.
- Individual participant dataSharing planned: No
Related trials for Shellfish Hypersensitivity
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Recombinant Tropomyosin- and Hemocyanin-Specific IgE in Children With Suspected Shrimp Allergy
Food Hypersensitivity, Shellfish Allergy
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing NOVAPAK nasal packing applied to forearm and NOVAPAK nasal packing applied to nasal cavity in people with Shellfish Hypersensitivity and Epistaxis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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 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: status not confirmed, as of the sponsor's last update on 11 Sep 2023. 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 Canada. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Leigh J Sowerby, MD (+15196466143, rhinologyclinic@sjhc.london.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First stage - Skin test (time frame: Until one hour after the test.). The study lists 3 primary outcomes in all. 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 NCT05343650, which also lists 14 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 11 Sep 2023.