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Not yet recruiting NCT06679465

Evaluating the Impact of Single Dose Tiotropium on Allergen-induced Early Asthmatic Response

Phase IV Interventional Asthma Bronchiale

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Tiotropium (Spiriva®), Placebo.
Who it may be relevant to
Registry conditions: Asthma Bronchiale. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Drug Tiotropium (Spiriva®)
    2 puffs tiotropium prior to allergen challenge
  • Drug Placebo
    2 puffs placebo

Primary outcome measures

  • Early asthmatic response [Time frame: 2 hours post-allergen challenge]
Secondary outcome measures (2)
  • Inflammatory response [Time frame: Five hours post-allergen challenge]
  • FEV1 [Time frame: 30 minutes]

Eligibility criteria

Inclusion criteria

  • 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)
  • baseline FEV1 ≥ 65% of predicted normal at Visit 1
  • evidence of atopy to an allergen suitable for inhalation challenge following skin prick testing such as house dust mite, grass, cat or horse
  • fall in FEV1 of ≥ 20% at a dose of methacholine ≤ 600mcg (methacholine PD20) at Visit 1
  • positive response to allergen inhalation challenge (fall in FEV1 of ≥ 15% after inhalation of allergen at a dilution 1:32 or more dillute.
  • absence of respiratory infection for at least 4 weeks prior to Visit 1
  • 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
  • women of child-bearing potential shall not be pregnant or lactating
  • non-smoker (cigarettes, vaping); ex-smoker with <10 pack year history allowed; cannabis use will be evaluated on a case-by-case basis
  • if on as needed budesonide/formoterol therapy, no reported use within 3 weeks prior to allergen challenge

Exclusion criteria

  • Smoker >10 pack year history

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Triple blind
Primary purpose
Treatment

Study locations

Canada · 1 center
  • University of Saskatchewan — Saskatoon

Identifiers

NCT: NCT06679465 · 5080

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗