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NCT Number: NCT06679465

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Saskatchewan

Saskatoon, Saskatchewan, S7M 2W2, Canada

Location contact

Brianne Philipenko, MD

CONTACT

[email protected]

306-956-3444 ext. 4

Brianne Philipenko, MD

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tiotropium (Spiriva®)

Drug

2 puffs tiotropium prior to allergen challenge

Placebo

Drug

2 puffs placebo

Primary outcomes

  1. Early asthmatic response

    Time frame: 2 hours post-allergen challenge

    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.

Secondary outcomes

  1. Inflammatory response

    Time frame: Five hours post-allergen challenge

    • Evaluate effect of single dose tiotropium versus single dose matched placebo on airway inflammation five hours after allergen challenge through analyses of sputum eosinophil counts, and cytokine analysis including IL-4, 5, 13 and TSLP.
  2. FEV1

    Time frame: 30 minutes

    • Evaluate bronchodilating effect of single dose tiotropium versus placebo on baseline lung function by comparing maximal FEV1 pre versus 30 minutes post treatment (i.e. prior to allergen challenge).

Sponsors and collaborators

Lead sponsor

University of Saskatchewan

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Nov 7, 2024
Registry last updated
Nov 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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