Injection Reactions SitePhase 1/2NCT03963115
Can Epinephrine Coated Syringe for Subcutaneous Immunotherapy (SCIT) Reduce Large Local Reaction?
A Phase 1/2 study testing Epinephrine or normal saline in people with Injection Reactions Site and Systemic Reactions, run by Mahidol University at 1 site in Thailand.
Trial summary
Allergen immunotherapy is effective in the management of allergic asthma, allergic rhinitis/conjunctivitis, and stinging insect hypersensitivity. The most common side effect of subcutaneous allergen specific immunotherapy (SCIT) is local reactions (LR). Read more about this study
- Who is it for?
- Ages 6 to 40 years
- Conditions the study is for
- Injection Reactions Site, Systemic Reactions
- What is being tested?
- Epinephrine or normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteThailand
- Study dates
- 24 Oct 2018to 1 Sep 2019
- Phase
- Phase 1/2
- 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 6 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients older than 6 years old who received SCIT at Pediatrics allergy departments at Siriraj hospital
- Patients who develops larges local reactions(mean wheal diameter > 25 mm.) during SCIT.
- Patients who received SCIT in maintenance phase.
Who cannot join
- Patients who develops systemic reactions (more than grade 1) during SCIT.
Trial locations and contacts
1 site in 1 country.
About this study
Allergen immunotherapy is effective in the management of allergic asthma, allergic rhinitis/conjunctivitis, and stinging insect hypersensitivity. The most common side effect of subcutaneous allergen specific immunotherapy (SCIT) is local reactions (LR). Although some studies indicated that LR did not predict systemic reaction (SR), patients with higher frequency of large local reaction (LLR) were reported to have higher risk for SR. Epinephrine may decrease LLR due to its vasoconstrictive effect . The objective of this study was to compare the size of LLR in patients receiving SCIT with epinephrine or normal saline coated syringe. The patients who complained of frequent LLR despite pre-medication and local treatment were recruited.
Read the detailed description
Allergen immunotherapy (AIT) is an immune mediated treatment which modifies T helper (Th) 2-directed response through the interplay between regulatory T and B cells, blocking IgG4 antibodies and tissue effector-mediated mechanisms. Aeroallergen immunotherapy is recommended for patients with allergic rhinitis, allergic conjunctivitis or allergic asthma whose symptoms were not adequately controlled by antigen avoidance and pharmacotherapy. AIT could reduce symptoms and medication usage in respiratory allergy. In children, AIT prevented the progression from allergic rhinitis to asthma and prevented new onset of allergen sensitization in monosensitized patients. The administration of allergen by subcutaneous injection (SCIT) is a common practice among allergists.
The benefits of SCIT must be weighed against the risks of side effects which can be mild or life threatening. Adverse allergic reactions to SCIT were classified as either local (LR) or systemic reactions (SR).6 Large local reactions (LLR) are defined as erythema and/or swelling (> 25 mm) at the site of injection. The timing of adverse reactions were categorized into immediate (occurring within 30 min) and late reactions (occurring > 30 min after injection). LR associated with SCIT ranged from 26-72% of patients and 0.7-4% of injections. SR were reported to occurred in 3.7% of patients and 0.3% of injection. Recent prospective study in pediatric patients who received SCIT showed immediate LR in 54.6%, delayed LR in 56.1%, immediate SR in 2.2% and delayed SR in 7.4% of the patients. Severe SR were seen in 0.03% of all treatments which appeared within 30 minutes after the injections. The author concluded that children had similar rates of LR compared to adult patients but had lower rates of severe SR.
Several studies indicated that individual LR did not predict subsequent SR. The rate of SR were not change despite the dose adjustment after a LR. However, patients with greater frequency of LLR might be at an increased risk for future SR. Recognizing the significance of frequent LLRs is important for designing safer protocols for successful SCIT.
In the Division of Allergy and Clinical Immunology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University, we performed SCIT in approximately 100 patients and 2000 injections per year. The LR associated SCIT were complained in 75% of the patients. Of the patients who experienced LR, 80% had LR more than 25 mm which was considered LLR.
Many strategies to prevent or minimize LR were reported. Oral antihistamines, leukotriene receptor antagonist (LTRA) or anti-IgE could reduce LR during the built-up phase. Cold compression or topical steroid were used to reduce the LR without any strong evidence. To our knowledge, the benefit of epinephrine coated syringe prior to drawing the allergen extract for SCIT in patients with frequent LLR has never been explored in any controlled trial.
The objective of this study is to compare the size of LR in patients with frequent LLR who receive SCIT by coating syringe with epinephrine or placebo prior to drawing allergen extract.
- Conditions
- Injection Reactions Site, Systemic Reactions
- Being tested
- Epinephrine or normal saline
- Keywords
- Large local reaction, adrenaline, epinephrine
- Medical subject headings
- Injection Site Reaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epinephrine or normal salineDrug
Also called Adrenaline or normal saline
epinephreine or normal saline coated syringe before drawing allergen for injection.
| Study group | Role | What they receive |
|---|---|---|
| Coated syringe with epinephrine | Active comparator | Epinephrine was coated syinge before drawing the allergen to filled in. Receives: Drug: Epinephrine or normal saline |
| placebo | Placebo comparator | Normal saline was coated syinge before drawing the allergen to filled in. Receives: Drug: Epinephrine or normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epinephrine coated syringe for SCIT changed sized of large local reactions compared with placebo
We measured the sized of local reactions after injected SCIT coated with epinephrine or placebo for 30 minutes at clinic then 2 hours, 4 hours and 6 hours at home.
Measured: 30 minutes, 2 hours, 4 hours, 6 hours
Secondary outcomes (1)
Epinephrine coated syringe for SCIT changed systemic reactions compared with placebo.
We measured the systemic reactions after injected SCIT coated with epinephrine or placebo for 30 minutes at clinic then 2 hours, 4 hours and 6 hours at home.
Measured: 30 minutes, 2 hours, 4 hours, 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study start24 Oct 2018
- Primary completion25 Aug 2019
- Study completion1 Sep 2019
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 Injection Reactions SiteStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A randomized, double-blind, crossover trial with epinephrine coated syringe before injected and placebo was done in each visit in patients who developed large local reactions after subcutaneous immunotherapy.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Orathai Piboonpocanun, Mahidol University
- Investigators
- Orathai Piboonpocanun, MD, Principal investigator, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03963115
- Sponsor's protocol ID
- 393/2561(EC3)
- Status last verified
- Feb 2020
- First submitted
- 22 May 2019
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roy SR, Sigmon JR, Olivier J, Moffitt JE, Brown DA, Marshall GD. Increased frequency of large local reactions among systemic reactors during subcutaneous allergen immunotherapy. Ann Allergy Asthma Immunol. 2007 Jul;99(1):82-6. doi: 10.1016/S1081-1206(10)60626-6.
PubMed 17650835Calabria CW, Stolfi A, Tankersley MS. The REPEAT study: recognizing and evaluating periodic local reactions in allergen immunotherapy and associated systemic reactions. Ann Allergy Asthma Immunol. 2011 Jan;106(1):49-53. doi: 10.1016/j.anai.2010.10.025.
PubMed 21195945
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Epinephrine Coated Syringe for Subcutaneous Immunotherapy (SCIT) Reduce Large Local Reaction?
- ClinicalTrials.gov ID
- NCT03963115
- Acronym / sponsor ID
- 393/2561(EC3)
- Conditions
- Injection Reactions Site, Systemic Reactions
- Keywords
- Large local reaction, adrenaline, epinephrine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 24 Oct 2018 (actual)
- Primary completion
- 25 Aug 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 24 May 2019 (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.
Allergen immunotherapy is effective in the management of allergic asthma, allergic rhinitis/conjunctivitis, and stinging insect hypersensitivity. The most common side effect of subcutaneous allergen specific immunotherapy (SCIT) is local reactions (LR). Although some studies indicated that LR did not predict systemic reaction (SR), patients with higher frequency of large local reaction (LLR) were reported to have higher risk for SR. Epinephrine may decrease LLR due to its vasoconstrictive effect . The objective of this study was to compare the size of LLR in patients receiving SCIT with epinephrine or normal saline coated syringe. The patients who complained of frequent LLR despite pre-medication and local treatment were recruited.
Detailed description
Allergen immunotherapy (AIT) is an immune mediated treatment which modifies T helper (Th) 2-directed response through the interplay between regulatory T and B cells, blocking IgG4 antibodies and tissue effector-mediated mechanisms. Aeroallergen immunotherapy is recommended for patients with allergic rhinitis, allergic conjunctivitis or allergic asthma whose symptoms were not adequately controlled by antigen avoidance and pharmacotherapy. AIT could reduce symptoms and medication usage in respiratory allergy. In children, AIT prevented the progression from allergic rhinitis to asthma and prevented new onset of allergen sensitization in monosensitized patients. The administration of allergen by subcutaneous injection (SCIT) is a common practice among allergists.
The benefits of SCIT must be weighed against the risks of side effects which can be mild or life threatening. Adverse allergic reactions to SCIT were classified as either local (LR) or systemic reactions (SR).6 Large local reactions (LLR) are defined as erythema and/or swelling (> 25 mm) at the site of injection. The timing of adverse reactions were categorized into immediate (occurring within 30 min) and late reactions (occurring > 30 min after injection). LR associated with SCIT ranged from 26-72% of patients and 0.7-4% of injections. SR were reported to occurred in 3.7% of patients and 0.3% of injection. Recent prospective study in pediatric patients who received SCIT showed immediate LR in 54.6%, delayed LR in 56.1%, immediate SR in 2.2% and delayed SR in 7.4% of the patients. Severe SR were seen in 0.03% of all treatments which appeared within 30 minutes after the injections. The author concluded that children had similar rates of LR compared to adult patients but had lower rates of severe SR.
Several studies indicated that individual LR did not predict subsequent SR. The rate of SR were not change despite the dose adjustment after a LR. However, patients with greater frequency of LLR might be at an increased risk for future SR. Recognizing the significance of frequent LLRs is important for designing safer protocols for successful SCIT.
In the Division of Allergy and Clinical Immunology, Department of Pediatrics, Faculty of Medicine Siriraj Hospital, Mahidol University, we performed SCIT in approximately 100 patients and 2000 injections per year. The LR associated SCIT were complained in 75% of the patients. Of the patients who experienced LR, 80% had LR more than 25 mm which was considered LLR.
Many strategies to prevent or minimize LR were reported. Oral antihistamines, leukotriene receptor antagonist (LTRA) or anti-IgE could reduce LR during the built-up phase. Cold compression or topical steroid were used to reduce the LR without any strong evidence. To our knowledge, the benefit of epinephrine coated syringe prior to drawing the allergen extract for SCIT in patients with frequent LLR has never been explored in any controlled trial.
The objective of this study is to compare the size of LR in patients with frequent LLR who receive SCIT by coating syringe with epinephrine or placebo prior to drawing allergen extract.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized, double-blind, crossover trial with epinephrine coated syringe before injected and placebo was done in each visit in patients who developed large local reactions after subcutaneous immunotherapy.
| Arm | Type | Receives |
|---|---|---|
| Coated syringe with epinephrine | Active comparator | Drug: Epinephrine or normal salineEpinephrine was coated syinge before drawing the allergen to filled in. |
| placebo | Placebo comparator | Drug: Epinephrine or normal salineNormal saline was coated syinge before drawing the allergen to filled in. |
Who may qualify
- Ages
- 6 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Patients older than 6 years old who received SCIT at Pediatrics allergy departments at Siriraj hospital
- Patients who develops larges local reactions(mean wheal diameter > 25 mm.) during SCIT.
- Patients who received SCIT in maintenance phase.
Key exclusion criteria (1 listed)
- Patients who develops systemic reactions (more than grade 1) during SCIT.
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 |
|---|---|---|
| Epinephrine or normal salineAlso: Adrenaline or normal salineepinephreine or normal saline coated syringe before drawing allergen for injection. | Drug | Coated syringe with epinephrine, placebo |
Primary outcome
Epinephrine coated syringe for SCIT changed sized of large local reactions compared with placebo
Time frame: 30 minutes, 2 hours, 4 hours, 6 hours
We measured the sized of local reactions after injected SCIT coated with epinephrine or placebo for 30 minutes at clinic then 2 hours, 4 hours and 6 hours at home.
1 secondary outcome
Epinephrine coated syringe for SCIT changed systemic reactions compared with placebo.
Time frame: 30 minutes, 2 hours, 4 hours, 6 hours
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 20 Feb 2020.
- Results publication: PubMed 17650835Roy SR, Sigmon JR, Olivier J, Moffitt JE, Brown DA, Marshall GD. Increased frequency of large local reactions among systemic reactors during subcutaneous allergen immunotherapy. Ann Allergy Asthma Immunol. 2007 Jul;99(1):82-6. doi: 10.1016/S1081-1206(10)60626-6.
- Results publication: PubMed 21195945Calabria CW, Stolfi A, Tankersley MS. The REPEAT study: recognizing and evaluating periodic local reactions in allergen immunotherapy and associated systemic reactions. Ann Allergy Asthma Immunol. 2011 Jan;106(1):49-53. doi: 10.1016/j.anai.2010.10.025.
- Individual participant dataSharing planned: No
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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.
Orathai Piboonpocanun, MD principal investigator
Siriraj Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Epinephrine or normal saline in people with Injection Reactions Site and Systemic Reactions, run by Mahidol University at 1 site in Thailand.
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: finished, as of the sponsor's last update on 20 Feb 2020. 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 Thailand. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Epinephrine coated syringe for SCIT changed sized of large local reactions compared with placebo (time frame: 30 minutes, 2 hours, 4 hours, 6 hours). 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 NCT03963115, 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 20 Feb 2020.