Tiotropium for Asthma

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Saskatchewan

Disqualifiers: Smoker >10 pack years, others

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

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called tiotropium, a bronchodilator, to evaluate its effectiveness for people with asthma when exposed to allergens like dust or pollen. Participants will receive either the tiotropium treatment or a placebo (a substance with no active medicine) to compare their effects. The goal is to measure how tiotropium affects breathing after allergen exposure. This trial may suit adults with asthma who have been allergy-tested for common triggers and have not experienced a recent asthma flare-up or respiratory infection. As a Phase 4 trial, this research aims to understand how the already FDA-approved and effective tiotropium benefits more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are using budesonide/formoterol as needed, you should not have used it within 3 weeks before the allergen challenge.

What is the safety track record for this treatment?

Research has shown that tiotropium is generally safe for people with asthma. One study found a lower chance of unwanted side effects with tiotropium than without it. Another report indicated that tiotropium was well-tolerated when used daily alongside other asthma treatments, such as inhaled steroids. Some common side effects included worsening asthma and reduced airflow from the lungs, but these were not very common. Overall, tiotropium is considered safe when used as directed. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Tiotropium is unique because it offers a new approach for treating asthma by targeting the muscarinic receptors in the airways, which can help relax and open up the air passages. While most asthma treatments, like inhaled corticosteroids and beta-agonists, focus on reducing inflammation or stimulating the lungs to open up, tiotropium works differently by blocking the receptors that tighten the airways. This alternative mechanism of action is what excites researchers, as it has the potential to improve asthma control for patients who do not respond well to standard therapies.

What is the effectiveness track record for tiotropium in treating asthma?

Research has shown that tiotropium can greatly improve lung function in people with asthma. Studies indicate it helps maintain better breathing throughout the day and can lead to improved asthma control. In this trial, participants will receive either tiotropium or a placebo. Tiotropium has improved lung function, even for those whose asthma wasn't managed well by standard treatments. This medication works well for people of different ages and with varying levels of asthma severity. Experts agree on its effectiveness, making it a reliable option for managing asthma. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals with asthma. Participants should be able to perform lung function tests and must not have had a respiratory infection or asthma exacerbation within the last four weeks. They cannot take part if they are currently smokers, have other significant health issues, or are using certain medications that might interfere with the study.

Inclusion Criteria

I haven't had a lung infection in the last 4 weeks.

No confounding health issue (i.e. no health conditions, other than asthma, that would put the participant at risk or affect data integrity as determined by the principal investigator)

I haven't used budesonide/formoterol for the last 3 weeks.

Exclusion Criteria

I have smoked more than 10 packs of cigarettes a year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single dose of tiotropium or placebo 30 minutes prior to allergen challenge

1 day

1 visit (in-person)

Follow-up

Participants are monitored for early asthmatic response and inflammatory response post-allergen challenge

1 day

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Tiotropium

Trial Overview

The trial is testing Tiotropium (Spiriva®), an inhaled medication, against a placebo. Each participant will receive a single dose of either Tiotropium or placebo before being exposed to an allergen to see how it affects their early asthmatic response by measuring changes in lung function.

How Is the Trial Designed?

Group I: Tiotropium treatment Experimental Treatment 1 Intervention

2 puffs tiotropium

Group II: Placebo Placebo Group 1 Intervention

2 puffs placebo

Who Is Running the Clinical Trial?

University of Saskatchewan

Lead Sponsor

Trials

261

Recruited

156,000+

Published Research Related to This Trial

Tiotropium, delivered via the Respimat® device, is safe and well-tolerated as an add-on therapy to inhaled corticosteroids in adults with symptomatic asthma, based on data from 3474 patients across seven clinical trials lasting 12-52 weeks.

The incidence of adverse events (AEs) was similar between tiotropium and placebo groups, with low rates of common side effects like dry mouth, indicating that tiotropium does not significantly increase the risk of side effects compared to placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of once-daily tiotropium Respimat(®) as add-on to at least inhaled corticosteroids in adult patients with symptomatic asthma: A pooled safety analysis. Dahl, R., Engel, M., Dusser, D., et al.[2018]

Citations

1.

tandfonline.com

tandfonline.com/doi/full/10.1080/02770903.2021.1914648

Full article: Efficacy and safety of add-on tiotropium in the ...

The addition of tiotropium resulted in asthma control and normalized lung function, as indicated by follow-up spirometry test results. Therefore, tiotropium may ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5833870/

Tiotropium for the Treatment of Asthma: Patient Selection ...

This review provides an overview of safety and efficacy data and discusses the use of tiotropium in patients across the range of asthma severities, ages, and ...

3.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa1208606

Tiotropium in Asthma Poorly Controlled with Standard ...

The results of these two replicate trials confirm that adding tiotropium once daily provided modest sustained bronchodilation over 24 hours.

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S0954611119301969

Tiotropium in asthma: From bench to bedside

Tiotropium significantly improved lung function across asthma severities and age groups. •. Add-on tiotropium might enable reductions in ICS dose in patients ...

5.

jtd.amegroups.org

jtd.amegroups.org/article/view/21800/html

Clinical predictors of the effectiveness of tiotropium in adults ...

Conclusions: Tiotropium add-on therapy in patients with uncontrolled asthma was effective. However, patients with serum total IgE level >430 µg/L were less ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6391545/

Safety of tiotropium in patients with asthma - PMC

The risk of an AE was significantly reduced with tiotropium [rate ratio (RR) (95% CI): 0.90 (0.87, 0.93)], as was the risk of an SAE [RR (95% CI): 0.94 (0.89, ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT01257230

Efficacy and Safety of 2 Doses of Tiotropium Via Respimat ...

The aim of the study is to evaluate efficacy and safety of a 48-week treatment with two doses of tiotropium bromide compared to placebo in adolescent ...

8.

sciencedirect.com

sciencedirect.com/science/article/pii/S0954611116301482

Safety and tolerability of once-daily tiotropium Respimat ...

The most commonly reported AEs, occurring in ≥2% of patients in any treatment group, are presented in Table 5. Asthma worsening/exacerbation, decreased peak ...

9.

jaci-inpractice.org

jaci-inpractice.org/article/S2213-2198(20)30364-0/fulltext

Tiotropium Respimat Efficacy and Safety in Asthma

Once-daily tiotropium Respimat add-on to ICS or ICS/long-acting β2-agonist therapy was effective and well tolerated in patients with asthma ...