IgE-mediated Abdominal PainPhase 3INSPIRENCT05653024
INhaled Salbutamol vs Placebo for the Treatment of Acute IgE-mediated Abdominal Pain From Allergic Food REactions
A Phase 3 study testing Salbutamol in people with IgE-mediated Abdominal Pain, run by Philippe Bégin at 1 site in Canada.
Trial summary
The goal of this study is to assess the efficacy of inhaled salbutamol to treat abdominal pain during food allergic reactions. Patients experiencing abominal pain as a result of a food allergic reaction during a food challenge in the allergy clinic will be invited to participate to the study. Read more about this study
- Who is it for?
- Ages 6 to 55 years
- Conditions the study is for
- IgE-mediated Abdominal Pain
- What is being tested?
- Salbutamol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2023to 5 May 2025
- 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 6 to 55 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subjects aged between 6 to 55 years old.
- Undergoing an oral food challenge or an oral immunotherapy up-dosing visit for the diagnosis or treatment of an IgE-mediated food allergy.
- Previous confirmation of the food allergy by either skin prick tests (SPT) or serum specific IgE;
- Able to express the intensity of their pain using the NRS-11;
- Willing to comply with all study requirements.
Who cannot join
- Previous adverse reactions to salbutamol;
- Known hypersensitivity to salbutamol or placebo or any of their components;
- Any condition that could be considered a relative contra-indication to the use of salbutamol according to the investigator (e.g. patient with a history of hyperglycemia, arrhythmia or hypokalemia);
- Patients receiving beta-blockers or a daily / long-acting beta agonists;
- Patients needing to pass an anti-doping test for high-level sport in the following 24h.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blind Randomized Controlled Trial of Inhaled Salbutamol vs Placebo for the Treatment of Acute Abdominal Pain From Food-induced IgE-mediated Reactions
The goal of this study is to assess the efficacy of inhaled salbutamol to treat abdominal pain during food allergic reactions.
Patients experiencing abominal pain as a result of a food allergic reaction during a food challenge in the allergy clinic will be invited to participate to the study.
They will receive either 8 puffs of salbutamol (asthma inhaler) or 8 puffs of a placebo inhaler.
The abdominal pain will then be followed using a numeric scale to see if patients receiving the medication experienced a faster improvement compared to those receiving the placebo.
Read the detailed description
This trial aims to compare the efficacy of inhaled salbutamol compared to placebo to decrease the duration of abdominal pain in children and adults with IgE-mediated food allergic reactions.
The population will be children and adults aged 6 to 55 presenting with moderate to severe IgE-mediated abdominal pain in the context of an oral food challenge or an oral immunotherapy dose increase at the allergy clinic.
Eligible participants will be randomized to receive an immediate treatement with either inhaled salbutamol 800 mcg or inhaled placebo, dispensed with a spacer, at a ratio of 1:1.
Participants will be asked to rate the evolution of their abdominal pain by the minute on the NRS-11 scale until it resolves completely or that they have been discharged.
Patients still presenting moderate to severe abdominal pain 30 minutes after the administration of the investigational product will receive an open-label treatment with 800 mcg of inhaled salbutamol.
The primary outcome is the time from treatment to a decrease of the abdominal pain down to a mild intensity (defined as a pain for which the patient would not normally seek treatment).
Participants will be contacted by phone after three days to document any adverse event.
The primary endpoint will be analysed using a log-rank test.
- Conditions
- IgE-mediated Abdominal Pain
- Being tested
- Salbutamol, Placebo
- Keywords
- food allergy, anaphylaxis
- Medical subject headings
- Food Hypersensitivity, Anaphylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalbutamolDrug
Also called Albuterol
8 puffs of 100 mcg inhaled salbutamol administered with spacer
PlaceboDrug
8 puffs of placebo inhaler administered with spacer
| Study group | Role | What they receive |
|---|---|---|
| Inhaled salbutamol | Experimental | 8 puffs of 100 mcg of inhaled salbutamol once Receives: Drug: Salbutamol |
| Placebo | Placebo comparator | 8 puffs of inhaled placebo once Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to resolution of moderate-to-severe abdominal pain
Time from treatment to an abdominal pain of less than moderate intensity, defined as a pain for which the patient would not normally seek treatment
Measured: From time of administation of investigational product, until the pain decreases to a point where the patient would not normally seek treatment, assessed up to 30 minutes
Secondary outcomes (4)
Time to complete resolution of the abdominal pain
Time from treatment to the complete resolution of the abdominal pain.
Measured: From time of administation of investigational product, until the pain is completely resolved, assessed up to 30 minutes
Time to any improvement in the abdominal pain
Time from treatment to any decrease in the 11-point numeric pain rating scale (NRS-11)
Measured: From time of administation of investigational product, until any decrease in the NRS-11, assessed up to 30 minutes
Epinephrine use
Overall rate of epinephrine administration following randomization
Measured: From randomization to three days after randomization
Adverse events
Overall rate of adverse events following randomization
Measured: From randomization to three days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2022
- Study start1 Jul 2023
- Primary completion5 May 2025
- Study completion5 May 2025
Why it stopped: Study was stopped due to unforseen changes in clinical practice (new oral immunotherapy focus on infants and toddlers) which led to a decrease in eligible participants and failure to meet recruitement targets.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgE-mediated Abdominal PainStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philippe Bégin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Philippe Bégin, St. Justine's Hospital
- Investigators
- Philippe Bégin, MD PhD, Principal investigator, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05653024
- Sponsor's protocol ID
- CITO-2022-01
- Acronym
- INSPIRE
- Status last verified
- May 2025
- First submitted
- 22 Nov 2022
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Available upon request to corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Randomized Controlled Trial of Inhaled Salbutamol vs Placebo for the Treatment of Acute Abdominal Pain From Food-induced IgE-mediated Reactions
- ClinicalTrials.gov ID
- NCT05653024
- Acronym / sponsor ID
- INSPIRE / CITO-2022-01
- Conditions
- IgE-mediated Abdominal Pain
- Keywords
- food allergy, anaphylaxis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was stopped due to unforseen changes in clinical practice (new oral immunotherapy focus on infants and toddlers) which led to a decrease in eligible participants and failure to meet recruitement targets.
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Philippe BéginUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 5 May 2025 (actual)
- Study completion
- 5 May 2025 (actual)
- First posted
- 15 Dec 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.
The goal of this study is to assess the efficacy of inhaled salbutamol to treat abdominal pain during food allergic reactions.
Patients experiencing abominal pain as a result of a food allergic reaction during a food challenge in the allergy clinic will be invited to participate to the study.
They will receive either 8 puffs of salbutamol (asthma inhaler) or 8 puffs of a placebo inhaler.
The abdominal pain will then be followed using a numeric scale to see if patients receiving the medication experienced a faster improvement compared to those receiving the placebo.
Detailed description
This trial aims to compare the efficacy of inhaled salbutamol compared to placebo to decrease the duration of abdominal pain in children and adults with IgE-mediated food allergic reactions.
The population will be children and adults aged 6 to 55 presenting with moderate to severe IgE-mediated abdominal pain in the context of an oral food challenge or an oral immunotherapy dose increase at the allergy clinic.
Eligible participants will be randomized to receive an immediate treatement with either inhaled salbutamol 800 mcg or inhaled placebo, dispensed with a spacer, at a ratio of 1:1.
Participants will be asked to rate the evolution of their abdominal pain by the minute on the NRS-11 scale until it resolves completely or that they have been discharged.
Patients still presenting moderate to severe abdominal pain 30 minutes after the administration of the investigational product will receive an open-label treatment with 800 mcg of inhaled salbutamol.
The primary outcome is the time from treatment to a decrease of the abdominal pain down to a mild intensity (defined as a pain for which the patient would not normally seek treatment).
Participants will be contacted by phone after three days to document any adverse event.
The primary endpoint will be analysed using a log-rank test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhaled salbutamol | Experimental | Drug: Salbutamol8 puffs of 100 mcg of inhaled salbutamol once |
| Placebo | Placebo comparator | Drug: Placebo8 puffs of inhaled placebo once |
Who may qualify
- Ages
- 6 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Subjects aged between 6 to 55 years old.
- Undergoing an oral food challenge or an oral immunotherapy up-dosing visit for the diagnosis or treatment of an IgE-mediated food allergy.
- Previous confirmation of the food allergy by either skin prick tests (SPT) or serum specific IgE;
- Able to express the intensity of their pain using the NRS-11;
- Willing to comply with all study requirements.
Key exclusion criteria (5 listed)
- Previous adverse reactions to salbutamol;
- Known hypersensitivity to salbutamol or placebo or any of their components;
- Any condition that could be considered a relative contra-indication to the use of salbutamol according to the investigator (e.g. patient with a history of hyperglycemia, arrhythmia or hypokalemia);
- Patients receiving beta-blockers or a daily / long-acting beta agonists;
- Patients needing to pass an anti-doping test for high-level sport in the following 24h.
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 |
|---|---|---|
| SalbutamolAlso: Albuterol8 puffs of 100 mcg inhaled salbutamol administered with spacer | Drug | Inhaled salbutamol |
| Placebo8 puffs of placebo inhaler administered with spacer | Drug | Placebo |
Primary outcome
Time to resolution of moderate-to-severe abdominal pain
Time frame: From time of administation of investigational product, until the pain decreases to a point where the patient would not normally seek treatment, assessed up to 30 minutes
Time from treatment to an abdominal pain of less than moderate intensity, defined as a pain for which the patient would not normally seek treatment
4 secondary outcomes
Time to complete resolution of the abdominal pain
Time frame: From time of administation of investigational product, until the pain is completely resolved, assessed up to 30 minutes
Time to any improvement in the abdominal pain
Time frame: From time of administation of investigational product, until any decrease in the NRS-11, assessed up to 30 minutes
Epinephrine use
Time frame: From randomization to three days after randomization
Adverse events
Time frame: From randomization to three days after randomization
Results and safety
The study was stopped early (reason given: Study was stopped due to unforseen changes in clinical practice (new oral immunotherapy focus on infants and toddlers) which led to a decrease in eligible participants and failure to meet recruitement targets.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Individual participant dataSharing planned: Yes. Available upon request to corresponding author
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.
Philippe Bégin, MD PhD principal investigator
St. Justine's Hospital
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 Salbutamol in people with IgE-mediated Abdominal Pain, run by Philippe Bégin 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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 21 May 2025. 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. 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 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 was stopped early (reason given: Study was stopped due to unforseen changes in clinical practice (new oral immunotherapy focus on infants and toddlers) which led to a decrease in eligible participants and failure to meet recruitement targets.). Results are not available in the source record.
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?
Time to resolution of moderate-to-severe abdominal pain (time frame: From time of administation of investigational product, until the pain decreases to a point where the patient would not normally seek treatment, assessed up to 30 minutes). 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 21 May 2025.