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Salbutamol Inhaler for Allergic Abdominal Pain (INSPIRE Trial)

Phase 3

Recruiting

Research Sponsored by Philippe Bégin

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects aged between 6 to 55 years old.

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from time of administation of open-label rescue treatment, until complete resolution of the abdominal pain, assessed up to patient discharge

Awards & highlights

INSPIRE Trial Summary

This trial will assess if an asthma inhaler can reduce abdominal pain caused by food allergies. Patients will get either the inhaler or placebo & their pain scores will be tracked.

Who is the study for?

This trial is for people aged 6 to 55 who can rate their pain and are having a food allergy test or treatment. They must have confirmed food allergies through skin tests or blood tests.Check my eligibility

What is being tested?

The study is testing if inhaled salbutamol, an asthma medication, can relieve abdominal pain faster than a placebo during allergic reactions from food challenges in the clinic.See study design

What are the potential side effects?

Salbutamol may cause side effects like shaky hands, fast heartbeat, headaches, muscle cramps, and sometimes more serious heart issues.

INSPIRE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 6 and 55 years old.

INSPIRE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from time of administation of investigational product, until any decrease in the nrs-11, assessed up to 30 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from time of administation of investigational product, until any decrease in the nrs-11, assessed up to 30 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and from time of administation of investigational product, until any decrease in the nrs-11, assessed up to 30 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to resolution of moderate-to-severe abdominal pain

Secondary outcome measures

Adverse events

Epinephrine use

Time to any improvement in the abdominal pain

+1 more

Other outcome measures

Time to any improvement in abdominal pain after open-label rescue

Time to resolution of abdominal pain after open-label rescue

Time to resolution of moderate-to-severe abdominal pain after open-label rescue

Side effects data

From 2014 Phase 4 trial • 152 Patients • NCT01922271

Nasopharyngitis

Hypercholesterolaemia

Acute myocardial infarction

Myocardial infarction

Condition aggravated

Urinary tract infection

Excoriation

Headache

Chronic obstructive pulmonary disease

Cough

Dyspnoea

100%

80%

60%

40%

20%

Study treatment Arm

NVA237

Tiotropium

INSPIRE Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Inhaled salbutamolExperimental Treatment1 Intervention

8 puffs of 100 mcg of inhaled salbutamol once

Group II: PlaceboPlacebo Group1 Intervention

8 puffs of inhaled placebo once

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Salbutamol

1998

Completed Phase 4

~3890

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Philippe BéginLead Sponsor

2 Previous Clinical Trials

104 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the study permit individuals below eighty years of age to participate?

"This research study is open to applicants aged between 6 and 55. For those younger than this cutoff, there are 14 trials available while the elderly have access to 12 separate clinical studies."

Answered by AI

Does this research still have the capacity to accept new participants?

"Affirmative. According to clinicaltrials.gov, this research effort is still enrolling participants. It was first published on July 1st 2023 and the most recent update occurred on November 24th 2023. 498 individuals are needed from a single site for this trial's completion."

Answered by AI

What is the maximum number of participants that this trial can accommodate?

"Affirmative. Clinicaltrials.gov confirms that this investigation, which was launched on July 1st 2023, is still actively recruiting patients for participation. 498 individuals are needed to be sourced from a single medical facility."

Answered by AI

Has the administration of Inhaled salbutamol been given approval by regulatory authorities?

"As it is a Phase 3 trial, there exists substantial clinical data affirming the safety of inhaled salbutamol. We here at Power are thus comfortable allocating this medication a score of 3/3 on our risk scale."

Answered by AI

Who can partake in this research endeavor?

"This clinical trial requires 498 volunteers, aged between 6 and 55 years old, who have previously been diagnosed with an IgE-mediated food allergy via skin prick tests or serum specific IgE. These participants must be undergoing oral food challenges or immunotherapy up-dosing visits for diagnosis/treatment of their allergic abdominal pain, able to gauge its intensity using the NRS-11 scale, and willing to comply with all study mandates."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

INhaled Salbutamol vs Placebo for the Treatment of Acute IgE-mediated Abdominal Pain From Allergic Food REactions

Philippe Bégin 2023. "INhaled Salbutamol vs Placebo for the Treatment of Acute IgE-mediated Abdominal Pain From Allergic Food REactions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05653024.

All > Food Allergy