AsthmaPhase 4NCT05113615
Regular Use Tiotropium and Tolerance to Bronchoprotection in Mild Asthma
A Phase 4 study testing Tiotropium Bromide in people with Asthma, run by University of Saskatchewan at 1 site in Canada.
Trial summary
The study will assess if regular use of tiotropium (i.e. daily) results in loss of bronchoprotection against methacholine induced bronchoconstriction in those with mild asthma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Tiotropium Bromide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- 13 Dec 2021to 6 May 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of asthma
- asthma is currently well controlled using only occasional bronchodilators
- baseline lung function (FEV1) is greater than 65% of the predicted value
- exhibit bronchoconstriction to inhaled methacholine at a dose of 200mcg or less
Who cannot join
- women who are pregnant or breastfeeding.
- diagnosis of another lung condition or medical condition that would pose a risk to the participant if enrolled in the study
- current smokers of nicotine products (e.g., cigarettes).
- users of cannabis or other inhaled recreational products (e.g., e-cigarettes or other vaping products) on a daily basis
- respiratory infection within 4 weeks of entering the study
- use of any anticholinergic agent within 30 days prior to the beginning of the study (e.g., ipratropium or the study treatment tiotropium).
- known hypersensitivity to tiotropium bromide or components of tiotropium formulation (e.g., benzalkonium chloride), to atropine or its derivatives.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Asthma Research Lab University of Saskatchewan Room 346 Ellis Hall
Saskatoon, Saskatchewan, S7N 0W8
About this study
Official title: Daily Dosing of Tiotropium and Tolerance to Bronchoprotection Against Methacholine Challenge
The study will assess if regular use of tiotropium (i.e. daily) results in loss of bronchoprotection against methacholine induced bronchoconstriction in those with mild asthma.
Read the detailed description
A single dose of an inhaled muscarinic antagonist will protect against methacholine induced bronchoconstriction and increase the dose of methacholine required to cause bronchoconstriction about 4 doubling doses. Beta agonist bronchodilators also shift the dose response curve to the right but the protection against methacholine induced bronchoconstriction is lost (i.e. tolerance develops) with regular use. This study will determine if bronchoprotection is lost following regular use of tiotropium.
This will be a randomized, double-blind placebo controlled study to assess the development of tolerance following regular use of tiotroium in a population of mild asthmatics.
Tiotropium will be administered at the clinically recommended dose (5mcg/day) for a total of 8 days. Methacholine challenges will be performed at baseline (pre-treatment), at one hour post first dose and on day 8, one hour after the final dose. The same will dosing schedule and assessments will occur with an identical placebo inhaler.
- Conditions
- Asthma
- Being tested
- Tiotropium Bromide, Matching placebo
- Keywords
- tiotropium, bronchoprotection, tolerance, methacholine PD20
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tiotropium BromideDrug
Also called Spiriva Respimat
respimat inhaler 2.5mcg/puff
Matching placeboDrug
matching placebo Respimat inhaler
| Study group | Role | What they receive |
|---|---|---|
| tiotropium bromide | Active comparator | tiotropium bromide inhaler (Spiriva Respimat) will be used once daily (2 puffs) for a total of 8 days Receives: Drug: Tiotropium Bromide |
| Matching placebo | Placebo comparator | matching placebo inhaler will be used once daily (2 puffs) for a total of 8 days Receives: Drug: Matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Methacholine PD20
dose of methacholine required to induce a 20% fall in FEV1 (volume of air forcefully exhaled in the first second following a full inhalation)
Measured: pre treatment
Methacholine PD20
dose of methacholine required to induce a 20% fall in FEV1 (volume of air forcefully exhaled in the first second following a full inhalation)
Measured: one hour post first dose
Methacholine PD20
dose of methacholine required to induce a 20% fall in FEV1 (volume of air forcefully exhaled in the first second following a full inhalation)
Measured: one hours post final dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2021
- Study start13 Dec 2021
- Primary completion6 May 2022
- Study completion6 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Don Cockcroft, University of Saskatchewan
- Investigators
- Don Cockcroft, MD, Principal investigator, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05113615
- Sponsor's protocol ID
- Bio ID 2985
- Status last verified
- May 2022
- First submitted
- 28 Oct 2021
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daily Dosing of Tiotropium and Tolerance to Bronchoprotection Against Methacholine Challenge
- ClinicalTrials.gov ID
- NCT05113615
- Acronym / sponsor ID
- Bio ID 2985
- Conditions
- Asthma
- Keywords
- tiotropium, bronchoprotection, tolerance, methacholine PD20
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- 13 Dec 2021 (actual)
- Primary completion
- 6 May 2022 (actual)
- Study completion
- 6 May 2022 (actual)
- First posted
- 9 Nov 2021 (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.
The study will assess if regular use of tiotropium (i.e. daily) results in loss of bronchoprotection against methacholine induced bronchoconstriction in those with mild asthma.
Detailed description
A single dose of an inhaled muscarinic antagonist will protect against methacholine induced bronchoconstriction and increase the dose of methacholine required to cause bronchoconstriction about 4 doubling doses. Beta agonist bronchodilators also shift the dose response curve to the right but the protection against methacholine induced bronchoconstriction is lost (i.e. tolerance develops) with regular use. This study will determine if bronchoprotection is lost following regular use of tiotropium.
This will be a randomized, double-blind placebo controlled study to assess the development of tolerance following regular use of tiotroium in a population of mild asthmatics.
Tiotropium will be administered at the clinically recommended dose (5mcg/day) for a total of 8 days. Methacholine challenges will be performed at baseline (pre-treatment), at one hour post first dose and on day 8, one hour after the final dose. The same will dosing schedule and assessments will occur with an identical placebo inhaler.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tiotropium bromide | Active comparator | Drug: Tiotropium Bromidetiotropium bromide inhaler (Spiriva Respimat) will be used once daily (2 puffs) for a total of 8 days |
| Matching placebo | Placebo comparator | Drug: Matching placebomatching placebo inhaler will be used once daily (2 puffs) for a total of 8 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of asthma
- asthma is currently well controlled using only occasional bronchodilators
- baseline lung function (FEV1) is greater than 65% of the predicted value
- exhibit bronchoconstriction to inhaled methacholine at a dose of 200mcg or less
Key exclusion criteria (7 listed)
- women who are pregnant or breastfeeding.
- diagnosis of another lung condition or medical condition that would pose a risk to the participant if enrolled in the study
- current smokers of nicotine products (e.g., cigarettes).
- users of cannabis or other inhaled recreational products (e.g., e-cigarettes or other vaping products) on a daily basis
- respiratory infection within 4 weeks of entering the study
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 BromideAlso: Spiriva Respimatrespimat inhaler 2.5mcg/puff | Drug | tiotropium bromide |
| Matching placebomatching placebo Respimat inhaler | Drug | Matching placebo |
Primary outcome
Methacholine PD20
Time frame: pre treatment
dose of methacholine required to induce a 20% fall in FEV1 (volume of air forcefully exhaled in the first second following a full inhalation)
Methacholine PD20
Time frame: one hour post first dose
dose of methacholine required to induce a 20% fall in FEV1 (volume of air forcefully exhaled in the first second following a full inhalation)
Methacholine PD20
Time frame: one hours post final dose
dose of methacholine required to induce a 20% fall in FEV1 (volume of air forcefully exhaled in the first second following a full inhalation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- 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. This study is not recruiting at the moment.
Don Cockcroft, MD principal investigator
University of Saskatchewan
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 Bromide in people with Asthma, 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 23 May 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Methacholine PD20 (time frame: pre treatment). The study lists 3 primary outcomes in all. 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 23 May 2022.