Salbutamol Inhaler for Allergic Abdominal Pain

(INSPIRE Trial)

No longer recruiting at 1 trial location

Overseen By Sabrina Cerro, BSc

Age: < 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Philippe Bégin

Must not be taking: Beta-blockers, Long-acting beta agonists

Disqualifiers: Adverse reaction to salbutamol, Hypersensitivity, Hyperglycemia, Arrhythmia, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: Immediate treatment

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether an asthma inhaler, specifically salbutamol, can reduce abdominal pain during food allergic reactions. Participants will receive either the salbutamol inhaler or a placebo (an inactive inhaler) to compare effects. The trial targets individuals who experience stomach pain during allergic reactions and are undergoing food allergy testing. Participants must have a confirmed food allergy and be able to describe their pain level. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

If you are taking beta-blockers or daily/long-acting beta agonists, you will need to stop these medications to participate in the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that salbutamol, a common ingredient in asthma inhalers, is generally safe. Some users may experience a fast or irregular heartbeat, known as palpitations or tachycardia, but these side effects are usually mild.

Evidence also suggests that inhaled medications like salbutamol might cause minor stomach issues. In one study, 6.4% of people using salbutamol inhalers reported these problems, though this represents a small number of users.

Salbutamol is a trusted treatment for breathing problems and has FDA approval for asthma, indicating its safety for many people. However, discussing any concerns with a doctor before starting treatment is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the salbutamol inhaler for allergic abdominal pain because it offers a unique approach compared to traditional treatments like antihistamines and corticosteroids. Unlike these standard options, which are usually taken orally or through injections, salbutamol is administered via inhalation, allowing for rapid absorption and potentially quicker relief. Salbutamol, typically used for asthma, works by relaxing the muscles in the airways and might similarly ease abdominal pain by targeting smooth muscles in the digestive tract. This new delivery method and mechanism of action provide a promising alternative for those suffering from allergic abdominal pain.

What evidence suggests that salbutamol might be an effective treatment for allergic abdominal pain?

In this trial, participants will receive either inhaled salbutamol or a placebo to evaluate its effectiveness in easing stomach pain from food allergies. Research has shown that inhaled salbutamol, a common asthma medication, might help alleviate this type of pain. In particular, patients in studies who took high doses of inhaled salbutamol experienced faster pain relief compared to those who did not. The main focus was on how quickly the pain improved after starting the treatment, suggesting it could be a promising way to manage this allergic reaction. Early results indicate that salbutamol might be an effective choice for people with food allergy-related stomach pain. ^{3 4 5 6 7}

Who Is on the Research Team?

Philippe Bégin, MD PhD

Principal Investigator

St. Justine's Hospital

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am undergoing treatment or testing for a food allergy.

You have confirmed food allergies through skin prick tests or specific blood tests.

You are ready to follow all the rules of the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either 8 puffs of inhaled salbutamol or placebo to treat abdominal pain during food allergic reactions

Immediate treatment

1 visit (in-person)

Open-label Rescue

Participants with moderate to severe pain 30 minutes post-treatment receive open-label inhaled salbutamol

Up to patient discharge

Follow-up

Participants are contacted by phone to document any adverse events

3 days

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Salbutamol

Trial Overview 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.

How Is the Trial Designed?

Group I: Inhaled salbutamol Experimental Treatment 1 Intervention

8 puffs of 100 mcg of inhaled salbutamol once

Group II: Placebo Placebo Group 1 Intervention

8 puffs of inhaled placebo once

Who Is Running the Clinical Trial?

Philippe Bégin

Lead Sponsor

Trials

3

Recruited

600+

Published Research Related to This Trial

In a study involving 12 non-smoking asthmatic patients, the novel Easyhaler powder inhaler delivered 24% of the sulbutamol dose to the lungs, demonstrating effective pulmonary deposition.

The clinical efficacy of the Easyhaler was found to be comparable to that of a metered dose inhaler with a spacer, as both methods showed similar improvements in lung function measurements (FEV1).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary deposition and clinical response of 99mTc-labelled salbutamol delivered from a novel multiple dose powder inhaler. Vidgren, M., Arppe, J., Vidgren, P., et al.[2019]

Proventil HFA (albuterol) demonstrated a safety profile similar to Ventolin over 12 weeks of treatment in asthmatic patients, with no significant adverse events reported compared to a placebo.

Both Proventil HFA and Ventolin effectively maintained asthma control without deterioration, as indicated by stable asthma symptom scores and minimal changes in vital signs and laboratory tests.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proventil HFA and ventolin have similar safety profiles during regular use. Tinkelman, DG., Bleecker, ER., Ramsdell, J., et al.[2019]

Indacaterol 200 microg demonstrated superior bronchodilator efficacy compared to placebo, salbutamol, and salmeterol in patients with persistent asthma, providing effective 24-hour relief.

The safety profile of indacaterol was favorable, with only mild to moderate adverse events reported, and no significant sustained systemic side effects observed even at higher doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of single therapeutic and supratherapeutic doses of indacaterol versus salmeterol and salbutamol in patients with asthma. Brookman, LJ., Knowles, LJ., Barbier, M., et al.[2015]

In a study involving 24 asthmatic patients, both HFA 134a salbutamol sulfate and CFC 11/12 salbutamol showed equivalent improvements in lung function (FEV1 and FVC) after inhalation, indicating similar efficacy.

The safety profiles of both medications were comparable, with no significant differences in heart rate, blood pressure, or adverse events, suggesting that HFA 134a salbutamol sulfate is a safe alternative to CFC 11/12 salbutamol.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cumulative dose-response study of non-CFC propellant HFA 134a salbutamol sulfate metered-dose inhaler in patients with asthma. Kleerup, EC., Tashkin, DP., Cline, AC., et al.[2019]

The Airmax multidose dry powder inhaler delivering salbutamol is equally effective as the standard pressurized metered dose inhaler (Ventolin) in improving lung function (FEV1) in asthmatic patients, with a 1:1 dose equivalence established in a study of 61 adults.

Both Airmax and Ventolin showed similar safety profiles, and the Airmax inhaler offers advantages such as eliminating the need for coordinated actuation and inhalation, along with a built-in dose counter.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bronchodilating effects of salbutamol from a novel inhaler Airmax. Middle, MV., Terblanché, J., Perrin, VL., et al.[2019]

In a study involving 12 asthma patients, both pirbuterol (400 micrograms) and salbutamol (200 micrograms) were found to significantly induce bronchodilation, improving airflow in patients with stable reversible broncho-obstruction.

The study indicated that pirbuterol and salbutamol have similar efficacy in treating asthma symptoms, with minimal side effects reported, suggesting they are both safe options for bronchodilation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Comparative studies on pirbuterol, salbutamol and a placebo administered as an aerosol in asthmatic patients]. Verstraeten, JM.[2013]

In a double-blind controlled trial involving nine patients with severe chronic airway obstruction, all participants preferred nebulized salbutamol over placebo, indicating its potential efficacy in improving symptoms.

Patients showed significant improvements in morning and evening peak flow measurements and reported lower symptom scores for breathlessness, wheezing, and sputum production during the active treatment period, suggesting that nebulized salbutamol may be beneficial for those not responding to conventional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Domiciliary nebulised salbutamol solution in severe chronic airway obstruction. Wilson, RS., Connellan, SJ.[2019]

In a study involving 31 asthmatic participants, two brands of salbutamol metered-dose inhalers (MDIs) were compared for their bronchodilator efficacy using specific airways conductance (SGaw) as a measure.

The results indicated that even though the salbutamol formulations are chemically equivalent, they can have significantly different therapeutic effects, highlighting the importance of brand choice in asthma treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differing bioavailability of salbutamol metered-dose inhalers. Chhabra, SK.[2019]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33831623/

Potential Efficacy of High-Dose Inhaled Salbutamol for the ... The primary outcome measure was the delay between the initiation of therapy and improvement of abdominal pain. It was compared between patients who had received ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2213219821003858

Potential Efficacy of High-Dose Inhaled Salbutamol for the ... The primary outcome measure was the delay between the initiation of therapy and improvement of abdominal pain. It was compared between patients who had received ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05653024

INhaled Salbutamol vs Placebo for the Treatment of Acute ... 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- ...

4. jaci-inpractice.org jaci-inpractice.org/article/S2213-2198(21)00385-8/abstract

Potential Efficacy of High-Dose Inhaled Salbutamol for the ... The primary outcome measure was the delay between the initiation of therapy and improvement of abdominal pain. It was compared between patients ...

5. authorea.com authorea.com/users/471219/articles/562829-efficacy-of-high-dose-inhaled-salbutamol-for-the-treatment-of-gastro-intestinal-anaphylaxis

Efficacy of high-dose inhaled salbutamol for the treatment ... The primary outcome measure was the delay between the initiation of therapy and improvement of abdominal pain. It was compared between patients ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10730473/

Safety outcomes of salbutamol: A systematic review and ... This meta‐analysis indicated that salbutamol was associated with a very common risk of palpitations or tachycardia.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2648528/

Risk of Adverse Gastrointestinal Events from Inhaled ... Adverse gastrointestinal events were observed in 461 (6.4%) patients prescribed inhaled corticosteroids and albuterol and in 302 (2.5%) patients prescribed only ...