Asthma BronchialePhase 4NCT06679465
Evaluating the Impact of Single Dose Tiotropium on Allergen-induced Early Asthmatic Response
A Phase 4 study testing Tiotropium (Spiriva®) in people with Asthma Bronchiale, run by University of Saskatchewan at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma Bronchiale
- What is being tested?
- Tiotropium (Spiriva®)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jan 2025to Jan 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- Smoker >10 pack year history
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
University of Saskatchewan
Saskatoon, Saskatchewan, S7M 2W2
Brianne Philipenko, MD, 306-956-3444 ext. 4, bsp943@mail.usask.ca
Brianne Philipenko, MD
About this study
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.
- Conditions
- Asthma Bronchiale
- Being tested
- Tiotropium (Spiriva®), Placebo
- Keywords
- asthma, Tiotropium, Early asthmatic response
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tiotropium (Spiriva®)Drug
2 puffs tiotropium prior to allergen challenge
PlaceboDrug
2 puffs placebo
| Study group | Role | What they receive |
|---|---|---|
| Tiotropium treatment | Experimental | 2 puffs tiotropium Receives: Drug: Tiotropium (Spiriva®) |
| Placebo | Placebo comparator | 2 puffs placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 hours post-allergen challenge
Secondary outcomes (2)
Inflammatory response
- 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.
Measured: Five hours post-allergen challenge
FEV1
- 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).
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start1 Jan 2025 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma BronchialeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brianne Philipenko, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06679465
- Sponsor's protocol ID
- 5080
- Status last verified
- Oct 2024
- First submitted
- 25 Oct 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Single Dose Tiotropium on Allergen-induced Early Asthmatic Response
- ClinicalTrials.gov ID
- NCT06679465
- Acronym / sponsor ID
- 5080
- Conditions
- Asthma Bronchiale
- Keywords
- asthma, Tiotropium, Early asthmatic response
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 7 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tiotropium treatment | Experimental | Drug: Tiotropium (Spiriva®)2 puffs tiotropium |
| Placebo | Placebo comparator | Drug: Placebo2 puffs placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (1 listed)
- Smoker >10 pack year history
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tiotropium (Spiriva®)2 puffs tiotropium prior to allergen challenge | Drug | Tiotropium treatment |
| Placebo2 puffs placebo | Drug | Placebo |
Primary outcome
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.
2 secondary outcomes
Inflammatory response
Time frame: Five hours post-allergen challenge
FEV1
Time frame: 30 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tiotropium (Spiriva®) in people with Asthma Bronchiale, run by University of Saskatchewan at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early asthmatic response (time frame: 2 hours post-allergen challenge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2024.