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

10 Participants Needed

Trial Summary

What is the purpose of this trial?

Evaluate single dose (2 x 2.5mcg/puff; total dose 5mcg) effect of tiotropium administered 30 minutes prior to allergen challenge on allergen-induced EAR assessed as the maximal % fall in FEV1 after allergen inhalation compared to that of single dose (two puffs) matched placebo administered 30 minutes prior to allergen challenge.

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 data supports the effectiveness of the drug Tiotropium for asthma?

Research shows that Tiotropium, when added to inhaled corticosteroids, improves lung function and reduces the risk of asthma flare-ups in patients with moderate to severe asthma. ^{1 2 3 4 5}

Is tiotropium safe for humans?

Tiotropium has been evaluated for safety in several clinical trials for asthma, and it is generally considered safe for use in humans. It has been approved for asthma treatment in various countries, including the EU and the USA, based on safety data from these trials. ^{1 4 6 7 8}

How is the drug Tiotropium unique in treating asthma?

Tiotropium is unique because it is the only long-acting muscarinic antagonist (LAMA) approved for asthma treatment, providing bronchodilation by blocking acetylcholine receptors in the airways. It is used as an add-on therapy for patients whose asthma is not well controlled with standard treatments like inhaled corticosteroids and long-acting beta-2 agonists. ^{4 8 9 10 11}

Eligibility Criteria

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 am 18 years old or older.

Exclusion Criteria

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

Timeline

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Tiotropium or salmeterol as add-on therapy to inhaled corticosteroids for patients with moderate symptomatic asthma: two replicate, double-blind, placebo-controlled, parallel-group, active-comparator, randomised trials. [2022]

2. England 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. [2018]

3. China pubmed.ncbi.nlm.nih.gov

Clinical predictors of the effectiveness of tiotropium in adults with symptomatic asthma: a real-life study. [2022]

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

What is the role of tiotropium in asthma?: a systematic review with meta-analysis. [2018]

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

Effects of the addition of tiotropium on airway dimensions in symptomatic asthma. [2019]

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

The emerging role of tiotropium for patients with asthma. [2015]

7. China pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Tiotropium in the Treatment of Severe Persistent Asthma:Meta-analysis. [2018]

8. England pubmed.ncbi.nlm.nih.gov

Tiotropium for the treatment of asthma: a drug safety evaluation. [2017]

9. New Zealand pubmed.ncbi.nlm.nih.gov

The evolving role of tiotropium in asthma. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Tiotropium in asthma: From bench to bedside. [2020]

11. Egypt pubmed.ncbi.nlm.nih.gov

Tiotropium for the Treatment of Asthma: Patient Selection and Perspectives. [2019]