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Anticholinergic

Tiotropium for Asthma

Phase 4
Waitlist Available
Research Sponsored by University of Saskatchewan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Absence of significant worsening of asthma that requires health care intervention or prolonged change in medication due to allergen exposure (or other trigger) for at least 4 weeks prior to Visit 1
Age (years) at least 18 years
Must not have
Smoker >10 pack year history
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial

Summary

This trial aims to see how a single dose of tiotropium (a medication) affects the airway response to allergens in comparison to a placebo.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Tiotropium may cause side effects such as dry mouth, sore throat, coughing, and headache. In some cases, it can lead to more serious effects like difficulty breathing or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My asthma hasn't worsened or needed more treatment due to allergies in the last 4 weeks.
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I am 18 years old or older.
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I am not pregnant or breastfeeding.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have smoked more than 10 packs of cigarettes a year.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 hours post-allergen challenge
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 hours post-allergen challenge for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Early asthmatic response
Secondary study objectives
FEV1
Inflammatory response

Side effects data

From 2018 Phase 4 trial • 76 Patients • NCT03055988
7%
Chronic obstructive pulmonary disease
3%
Nasopharyngitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Fluticasone Propionate + Salmeterol FDC (F+S 1000/100)
Tiotropium + Olodaterol FDC (T+O 5/5)

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Tiotropium treatmentExperimental Treatment1 Intervention
2 puffs tiotropium
Group II: PlaceboPlacebo Group1 Intervention
2 puffs placebo

Find a Location

Who is running the clinical trial?

University of SaskatchewanLead Sponsor
256 Previous Clinical Trials
155,367 Total Patients Enrolled
24 Trials studying Asthma
480 Patients Enrolled for Asthma
~7 spots leftby Jan 2027
Unbiased ResultsWe believe in providing patients with all the options.
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