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Tiotropium treatment 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
* age (years) at least 18 years
* 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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 minutes
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

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.

Eligible Conditions
  • Asthma

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
154,442 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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