Salbutamol Inhaler for Allergic Abdominal Pain

(INSPIRE Trial)

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

24 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 salbutamol generally safe for human use?

Salbutamol, also known as albuterol and by other brand names, has been studied for safety in various conditions like asthma and chronic airway obstruction. These studies generally show that salbutamol is safe for regular use, with few side effects reported. ^{1 2 3 4 5}

How does the drug salbutamol differ from other treatments for allergic abdominal pain?

Salbutamol is typically used as a bronchodilator for asthma and other respiratory conditions, and its use for allergic abdominal pain is novel. Unlike standard treatments for abdominal pain, which may include antispasmodics or pain relievers, salbutamol works by relaxing muscles in the airways, which is a unique approach for this condition. ^{2 4 6 7 8}

Research Team

Philippe Bégin, MD PhD

Principal Investigator

St. Justine's Hospital

Eligibility Criteria

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.

Can tell how much their pain bothers them using a pain scale called NRS-11.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Proventil HFA and ventolin have similar safety profiles during regular use. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Cumulative dose-response study of non-CFC propellant HFA 134a salbutamol sulfate metered-dose inhaler in patients with asthma. [2019]

3. Belgium pubmed.ncbi.nlm.nih.gov

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

4. England pubmed.ncbi.nlm.nih.gov

Domiciliary nebulised salbutamol solution in severe chronic airway obstruction. [2019]

5. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of single therapeutic and supratherapeutic doses of indacaterol versus salmeterol and salbutamol in patients with asthma. [2015]

6. England pubmed.ncbi.nlm.nih.gov

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

7. England pubmed.ncbi.nlm.nih.gov

Bronchodilating effects of salbutamol from a novel inhaler Airmax. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Pulmonary deposition and clinical response of 99mTc-labelled salbutamol delivered from a novel multiple dose powder inhaler. [2019]