NCT06679465

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_4

Timeline
8mo left

Started Jan 2025

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Jan 2025Jan 2027

First Submitted

Initial submission to the registry

October 25, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 7, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

November 7, 2024

Status Verified

October 1, 2024

Enrollment Period

2 years

First QC Date

October 25, 2024

Last Update Submit

November 6, 2024

Conditions

Asthma Bronchiale

Keywords

asthmaTiotropiumEarly asthmatic response

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 hours post-allergen challenge

Secondary Outcomes (2)

  • Inflammatory response

    Five hours post-allergen challenge

  • FEV1

    30 minutes

Study Arms (2)

Tiotropium treatment

EXPERIMENTAL

2 puffs tiotropium

Drug: Tiotropium (Spiriva®)

Placebo

PLACEBO COMPARATOR

2 puffs placebo

Drug: Placebo

Interventions

Tiotropium (Spiriva®)DRUG

2 puffs tiotropium prior to allergen challenge

Tiotropium treatment
PlaceboDRUG

2 puffs placebo

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Smoker \>10 pack year history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Saskatchewan

Saskatoon, Saskatchewan, S7M 2W2, Canada

Location

MeSH Terms

Conditions

Asthma

Interventions

Tiotropium Bromide

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Scopolamine DerivativesTropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD FRCPC

Study Record Dates

First Submitted

October 25, 2024

First Posted

November 7, 2024

Study Start

January 1, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

November 7, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)