AnaphylaxisPhase 1NCT03523221
Use of Dexamethasone in Prevention of the Second Phase or a Biphasic Reaction of Anaphylaxis
A Phase 1 study testing Dexamethasone Oral in people with Anaphylaxis, run by Hamad Medical Corporation at 1 site in Qatar.
Trial summary
Anaphylaxis is an acute serious allergic reaction, with multi-organ system manifestations caused by the release of chemical mediators and it is potentially fatal . Between 5% and 14% of patients may experience a recurrence of anaphylaxis 8-12 hours after the initial presentation, called biphasic (late-phase) . Read more about this study
- Who is it for?
- Ages 3 months to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Anaphylaxis
- What is being tested?
- Dexamethasone Oral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 210 participants
- Where
- 1 siteQatar
- Study dates
- 15 Apr 2018to Dec 2024
- Phase
- Phase 1
- 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 3 months to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All patients 3 monthes-14years presenting to the Pediatric Emergency Department (AlSadd) with mild to moderate anaphylaxis
Who cannot join
- Patients with severe anaphylaxis. Patient with history of immunological diseases. Patients on steroids therapy Patient with moderate-severe asthma on medication Patients with severe asthma
Trial locations and contacts
1 site in 1 country.
Qatar1 site, 1 recruiting
- Recruiting
Hamad Medical Corporation
Doha, 3050
Rafah Sayyed, MD, +97455747045, ralsayyed@hamad.qa
About this study
Anaphylaxis is an acute serious allergic reaction, with multi-organ system manifestations caused by the release of chemical mediators and it is potentially fatal .
Between 5% and 14% of patients may experience a recurrence of anaphylaxis 8-12 hours after the initial presentation, called biphasic (late-phase) .
Read more
The mainstay of treatment for children experiencing anaphylaxis remains adrenaline and H1-antihistamines. Corticosteroids are not life-saving and do not have an immediate effect on the symptoms of anaphylaxis but may help reduce or prevent a biphasic "late phase" reaction .
The aim of this study is to compare the efficacy of oral glucocorticoids in prevention of the second phase or biphasic reaction of anaphylaxis, as compared to placebo in children, presenting to the pediatric emergency department (PEC Al-Sadd) with mild to moderate anaphylaxis (Prospective Study).
Patients will be randomized to either one of the two treatment:
Treatment 1: Dexamethasone 0.6mg/kg oral. Treatment 2 : Placebo All patients will be urgently treated for anaphylaxis according to guideline protocol. Enrolled patients will be given one of the study medications orally, and he /she will observe in the observation room with cardiac monitor and close monitoring by nurse.
The treating physician will discharge patient when he/she looks well, breathing comfortably, has oxygen saturation >94%, stable blood pressure and no gastrointestinal or neurological manifestation.
Discharge patients will be sent home on anti-histamine (cetirizine) for 5days. All patients will be followed up for one week post discharge by a phone call asking about the general condition, relapse of symptoms, or need for readmission.
Read the detailed description
Anaphylaxis is an acute serious allergic reaction, with multi-organ system manifestations caused by the release of chemical mediators . It requires immediate recognition and intervention.
The estimated rate of anaphylaxis in children was 10.5 per 100,000 persons-years . Although the Rochester Epidemiology Project showed a rate of 75.1 per 100,000 person-years in children aged 9 years and 65.2 per 100,000 person-years in children aged 10-19-years old.
In the state of Qatar with approximately 280,000 visits annually to Pediatric Emergency Center (PEC), there were 171 cases of anaphylaxis seen at the facility from September 2015 to September 2016.
Anaphylaxis is a clinical diagnosis based on typical systemic manifestations, due to exposure to a causative agent. There are many possible triggers, including food, medication, insect venoms, rubber latex and vaccines . In some individuals, anaphylaxis is idiopathic. Both IgE and non-IgE activation of mast cells and basophils that results in the release and production of several inflammatory and vasoactive substances, these substances most commonly involve the skin, respiratory, cardiovascular, and gastrointestinal systems. As a result, urticarial, angioedema, bronchospasm, laryngospasm, increased vascular permeability and decreased vascular tone.
Anaphylaxis involves a range of signs and symptoms from hives, wheezing and angioedema to cardiovascular collapse and death [9,10]. More than 80% of the patients will present with flushing, itching, hives, angioedema, or other skin or mucosal symptoms. Generally up to 70%, at least 2 organ systems (skin, respiratory, cardiovascular, gastrointestinal systems) are involved; however, only 10-45% have cardiovascular symptoms, including chest pain, hypotension, or shock . Between 5% and 14% of patients may experience a recurrence of anaphlactoid reaction 8-12 hours after the initial presentation, called Biphasic (late-phase) . Most of these reactions are mild or moderate . Risk factors for biphasic reactions include a severe initial reaction; presence of laryngeal edema or hypotension; delay in the administration of adrenaline (epinephrine); too small a dose of adrenaline; and a history of a previous biphasic reaction . Delayed symptoms can develop despite treatment .
The mainstay of treatment for children experiencing anaphylaxis remains adrenaline 1:1000 intramuscularly (IM) . H1-antihistamines are also commonly administered in anaphylaxis. The combination of H1 and H2 antihistamines appears to be more effective, especially for cutaneous symptoms . The onset of activity of these agents is slower than epinephrine and is considered next-in-line treatment.
International guidelines consider antihistamines and glucocorticoids as second-line . Corticosteroids are not life-saving and do not have an immediate effect on the symptoms of anaphylaxis, since it takes 4-6 hours to work.
Glucocorticoids are administered to 50% of individuals with anaphylaxis, despite a lack of compelling evidence supporting their use.
Recent retrospective study in emergency department, evaluated the association between glucocorticoids administration and prolonged length of stay. In 4years retrospective chart review study on anaphylaxis patient, 70% of study patients received glucocorticoids as part of their treatment. Glucocorticoids were not found to reduce follow up revisit in the three days post discharge. And it didn't decrease the likelihood of extra epinephrine need for flare of symptoms, and only found to decrease length of stay in severe anaphylaxis.
The existing evidence for the use of glucocorticoids appears to consist mainly of retrospective studies, case reports, and other descriptive literature. The need exists, however, for a prospective study on the use of glucocorticoids in the treatment of anaphylaxis and its effectiveness in prevention of biphasic reaction. The objective of the current study, therefore, is to complement the current research on anaphylaxis and to investigate if glucocorticoids are effective in the treatment of anaphylaxis and if it can prevent or limit biphasic reaction.
This will be the first randomized controlled trial to look at steroid use in anaphylaxis and its impact on anaphylaxis treatment on a prospective fashion which will be used to help standardize care in the use of steroid for this common condition.
- Conditions
- Anaphylaxis
- Being tested
- Dexamethasone Oral
- Keywords
- Mild -Moderate Anaphylaxis
- Medical subject headings
- Anaphylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone OralDrug
use of one dose of Dexamethasone orally.or placebo in addition to regular treatment of anaphylaxis
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone arm | Active comparator | All patients will be Urgently treated for anaphylaxis according to guideline protocol. Enrolled patients will be given one of study medication orally, and he /she will observe in the observation room with cardiac monitor and close monitoring by nurse. Receives: Drug: Dexamethasone Oral |
| Placebo arm | Placebo comparator | All patients will be Urgently treated for anaphylaxis according to guideline protocol. Enrolled patients will be given one of study medication orally, and he /she will observe in the observation room with cardiac monitor and close monitoring by nurse. Receives: Drug: Dexamethasone Oral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of single dose of oral Dexamethasone decrease revisit to health center facility with relapse of anaphylaxis.
Would the use of single dose of oral Dexamethasone decrease revisit to health center facility with relapse of anaphylaxis signs and symptoms within one week after enrollment?
Measured: 2 years
Secondary outcomes (1)
use of oral Dexamethasone decrease the need for second dose of epinephrine after discharge from hospital.
Would the use of oral Dexamethasone decrease the need for second dose of epinephrine after discharge from hospital?
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2018
- Study start15 Apr 2018
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
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 AnaphylaxisStudies of the same condition, open and under way.
- More trials run by Hamad Medical CorporationThe 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hamad Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, DR. KHALID AL-ANSARI, Hamad Medical Corporation
- Investigators
- Khalid Al ansari, FRCP, Principal investigator, Hamad Medical Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03523221
- Sponsor's protocol ID
- 171661/17
- Status last verified
- Aug 2024
- First submitted
- 1 May 2018
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Al Sayyed R, Alansari K. Randomized blinded pilot trial of corticosteroid after mild-moderate anaphylaxis to prevent recurrence. Medicine (Baltimore). 2025 Aug 1;104(31):e43600. doi: 10.1097/MD.0000000000043600.
PubMed 40760578Burroughs-Ray DC, Wells DR, Dennis MM, Jackson CD. Clinical Guideline Highlights for the Hospitalist: Anaphylaxis Management in Adults and Children. J Hosp Med. 2021 Feb;16(2):98-99. doi: 10.12788/jhm.3553.
PubMed 33496659
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Dexamethasone in Prevention of the Second Phase or a Biphasic Reaction of Anaphylaxis
- ClinicalTrials.gov ID
- NCT03523221
- Acronym / sponsor ID
- 171661/17
- Conditions
- Anaphylaxis
- Keywords
- Mild -Moderate Anaphylaxis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Hamad Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2018 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 14 May 2018 (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.
Anaphylaxis is an acute serious allergic reaction, with multi-organ system manifestations caused by the release of chemical mediators and it is potentially fatal .
Between 5% and 14% of patients may experience a recurrence of anaphylaxis 8-12 hours after the initial presentation, called biphasic (late-phase) .
The mainstay of treatment for children experiencing anaphylaxis remains adrenaline and H1-antihistamines. Corticosteroids are not life-saving and do not have an immediate effect on the symptoms of anaphylaxis but may help reduce or prevent a biphasic "late phase" reaction .
The aim of this study is to compare the efficacy of oral glucocorticoids in prevention of the second phase or biphasic reaction of anaphylaxis, as compared to placebo in children, presenting to the pediatric emergency department (PEC Al-Sadd) with mild to moderate anaphylaxis (Prospective Study).
Patients will be randomized to either one of the two treatment:
Treatment 1: Dexamethasone 0.6mg/kg oral. Treatment 2 : Placebo All patients will be urgently treated for anaphylaxis according to guideline protocol. Enrolled patients will be given one of the study medications orally, and he /she will observe in the observation room with cardiac monitor and close monitoring by nurse.
The treating physician will discharge patient when he/she looks well, breathing comfortably, has oxygen saturation >94%, stable blood pressure and no gastrointestinal or neurological manifestation.
Discharge patients will be sent home on anti-histamine (cetirizine) for 5days. All patients will be followed up for one week post discharge by a phone call asking about the general condition, relapse of symptoms, or need for readmission.
Detailed description
Anaphylaxis is an acute serious allergic reaction, with multi-organ system manifestations caused by the release of chemical mediators . It requires immediate recognition and intervention.
The estimated rate of anaphylaxis in children was 10.5 per 100,000 persons-years . Although the Rochester Epidemiology Project showed a rate of 75.1 per 100,000 person-years in children aged 9 years and 65.2 per 100,000 person-years in children aged 10-19-years old.
In the state of Qatar with approximately 280,000 visits annually to Pediatric Emergency Center (PEC), there were 171 cases of anaphylaxis seen at the facility from September 2015 to September 2016.
Anaphylaxis is a clinical diagnosis based on typical systemic manifestations, due to exposure to a causative agent. There are many possible triggers, including food, medication, insect venoms, rubber latex and vaccines . In some individuals, anaphylaxis is idiopathic. Both IgE and non-IgE activation of mast cells and basophils that results in the release and production of several inflammatory and vasoactive substances, these substances most commonly involve the skin, respiratory, cardiovascular, and gastrointestinal systems. As a result, urticarial, angioedema, bronchospasm, laryngospasm, increased vascular permeability and decreased vascular tone.
Anaphylaxis involves a range of signs and symptoms from hives, wheezing and angioedema to cardiovascular collapse and death [9,10]. More than 80% of the patients will present with flushing, itching, hives, angioedema, or other skin or mucosal symptoms. Generally up to 70%, at least 2 organ systems (skin, respiratory, cardiovascular, gastrointestinal systems) are involved; however, only 10-45% have cardiovascular symptoms, including chest pain, hypotension, or shock . Between 5% and 14% of patients may experience a recurrence of anaphlactoid reaction 8-12 hours after the initial presentation, called Biphasic (late-phase) . Most of these reactions are mild or moderate . Risk factors for biphasic reactions include a severe initial reaction; presence of laryngeal edema or hypotension; delay in the administration of adrenaline (epinephrine); too small a dose of adrenaline; and a history of a previous biphasic reaction . Delayed symptoms can develop despite treatment .
The mainstay of treatment for children experiencing anaphylaxis remains adrenaline 1:1000 intramuscularly (IM) . H1-antihistamines are also commonly administered in anaphylaxis. The combination of H1 and H2 antihistamines appears to be more effective, especially for cutaneous symptoms . The onset of activity of these agents is slower than epinephrine and is considered next-in-line treatment.
International guidelines consider antihistamines and glucocorticoids as second-line . Corticosteroids are not life-saving and do not have an immediate effect on the symptoms of anaphylaxis, since it takes 4-6 hours to work.
Glucocorticoids are administered to 50% of individuals with anaphylaxis, despite a lack of compelling evidence supporting their use.
Recent retrospective study in emergency department, evaluated the association between glucocorticoids administration and prolonged length of stay. In 4years retrospective chart review study on anaphylaxis patient, 70% of study patients received glucocorticoids as part of their treatment. Glucocorticoids were not found to reduce follow up revisit in the three days post discharge. And it didn't decrease the likelihood of extra epinephrine need for flare of symptoms, and only found to decrease length of stay in severe anaphylaxis.
The existing evidence for the use of glucocorticoids appears to consist mainly of retrospective studies, case reports, and other descriptive literature. The need exists, however, for a prospective study on the use of glucocorticoids in the treatment of anaphylaxis and its effectiveness in prevention of biphasic reaction. The objective of the current study, therefore, is to complement the current research on anaphylaxis and to investigate if glucocorticoids are effective in the treatment of anaphylaxis and if it can prevent or limit biphasic reaction.
This will be the first randomized controlled trial to look at steroid use in anaphylaxis and its impact on anaphylaxis treatment on a prospective fashion which will be used to help standardize care in the use of steroid for this common condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone arm | Active comparator | Drug: Dexamethasone OralAll patients will be Urgently treated for anaphylaxis according to guideline protocol. Enrolled patients will be given one of study medication orally, and he /she will observe in the observation room with cardiac monitor and close monitoring by nurse. |
| Placebo arm | Placebo comparator | Drug: Dexamethasone OralAll patients will be Urgently treated for anaphylaxis according to guideline protocol. Enrolled patients will be given one of study medication orally, and he /she will observe in the observation room with cardiac monitor and close monitoring by nurse. |
Who may qualify
- Ages
- 3 months to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- All patients 3 monthes-14years presenting to the Pediatric Emergency Department (AlSadd) with mild to moderate anaphylaxis
Key exclusion criteria (1 listed)
- Patients with severe anaphylaxis. Patient with history of immunological diseases. Patients on steroids therapy Patient with moderate-severe asthma on medication Patients with severe asthma
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 |
|---|---|---|
| Dexamethasone Oraluse of one dose of Dexamethasone orally.or placebo in addition to regular treatment of anaphylaxis | Drug | Dexamethasone arm, Placebo arm |
Primary outcome
Use of single dose of oral Dexamethasone decrease revisit to health center facility with relapse of anaphylaxis.
Time frame: 2 years
Would the use of single dose of oral Dexamethasone decrease revisit to health center facility with relapse of anaphylaxis signs and symptoms within one week after enrollment?
1 secondary outcome
use of oral Dexamethasone decrease the need for second dose of epinephrine after discharge from hospital.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Derived from this study: PubMed 40760578Al Sayyed R, Alansari K. Randomized blinded pilot trial of corticosteroid after mild-moderate anaphylaxis to prevent recurrence. Medicine (Baltimore). 2025 Aug 1;104(31):e43600. doi: 10.1097/MD.0000000000043600.
- Derived from this study: PubMed 33496659Burroughs-Ray DC, Wells DR, Dennis MM, Jackson CD. Clinical Guideline Highlights for the Hospitalist: Anaphylaxis Management in Adults and Children. J Hosp Med. 2021 Feb;16(2):98-99. doi: 10.12788/jhm.3553.
- Individual participant dataSharing planned: Undecided
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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.
Khalid Al ansari, FRCP principal investigator
Hamad Medical Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dexamethasone Oral in people with Anaphylaxis, run by Hamad Medical Corporation at 1 site in Qatar.
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 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 14 Aug 2024. 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 Qatar. 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 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.
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 Rafah Sayyed, Md (+974-55747045, ralsayyed@hamad.qa), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of single dose of oral Dexamethasone decrease revisit to health center facility with relapse of anaphylaxis. (time frame: 2 years). 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 NCT03523221, 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 14 Aug 2024.