Allergic AsthmaPhase 4NCT04648813
Tiotropium Efficacy Against Allergen Induced Early Asthmatic Responses
A Phase 4 study testing tiotropium bromide monohydrate (Spiriva Respimat) in people with Allergic Asthma, run by University of Saskatchewan at 1 site in Canada.
Trial summary
The study will compare the effect of inhaled tiotropium versus placebo on allergen induced early asthmatic responses in individuals with atopic asthma. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Allergic Asthma
- What is being tested?
- tiotropium bromide monohydrate (Spiriva Respimat)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- 13 Nov 2020to 20 Apr 2021
- 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
- signed informed consent
- diagnosis of mild asthma with a minimum 3 months history at the time of enrolment into the trial
- pre-bronchodilator FEV1 80% or greater than the predicted value
- positive response to inhaled methacholine (i.e. MCh PD20 ≤ 400mcg)
- evidence of atopy (i.e. positive skin prick test to an allergen that is appropriate for use in allergen inhalation challenge)
- no respiratory infection within 4 weeks of Visit 1
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- no allergen exposure within 4 weeks of Visit 1
- current non-smoker (ex-nicotine smoker with < 10 pack years evaluated case by case)
- use of β2 agonist rescue medications less than daily and no more than 4 times per week
- general good health with no other medical condition, medication use or lifestyle activities that would potentially alter the outcome of the allergen challenge
Who cannot join
- currently pregnant or breast-feeding
- current daily use of other inhaled recreational products (e.g. cannabis, e-cigarettes or other vaping products; occasional use requires 24 hour withhold)
- diagnosis or evidence of narrow angle glaucoma
- diagnosis or evidence of urinary retention
- known hypersensitivity to tiotropium, atropine or its derivatives (e.g. ipratropium) or components of tiotropium formulation (e.g. benzalkonium chloride)
- history of anaphylaxis or angioedema
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- current use of :
- inhaled corticosteroid including combination therapies
- inhaled muscarinic antagonists - except study treatment (e.g. ipratropium bromide)
- long-acting beta2-agonists (LABA; e.g. formoterol)
- leukotriene receptor antagonists (e.g. montelukast)
- biologics (e.g. benralizumab)
- allergen immunotherapy
- mast cell stabilizers (e.g. nedocromil sodium)
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
The study will compare the effect of inhaled tiotropium versus placebo on allergen induced early asthmatic responses in individuals with atopic asthma.
Read the detailed description
This is a single center, double-blind, randomized, placebo-controlled, crossover study. The study will consist of two one week treatment periods, one with tiotropium (two inhalations/5mcg/day) and one with placebo (2inhalations/day). A minimum two week washout period between treatments is required. Four visits over the course of approximately 4 weeks will be required to complete the study. Procedures at each visit are as follows:
Visit 1:
Participants will undergo consent procedures and if consent is provided measurements of FeNO, spirometry, airway responsiveness to methacholine, skin prick testing, skin titration endpoint testing and sputum induction will be performed. If participants meet eligibility criteria following these assessments, treatment 1 will be dispensed and the first dose administered. The participant will then self administer the treatment for the next six days (i.e. a total of 7 days of treatment) before returning for Visit 2.
Visit 2:
A final dose of treatment 1 will be administered. At 30 minutes post dose, FeNO testing, spirometry measurements and allergen inhalation challenge will be performed. Five hours after the allergen challenge, FeNO will again be measured and sputum induction will be performed.
Visits 3 and 4:
Visits 3 and 4 will be identical to Visit 1 and 2 except that no skin prick testing or skin titration endpoint testing will be required. At Visit 3 participants will be crossed over to treatment 2 and the first dose will be administered. Participants will self administer treatment 2 for the next six days before returning for Visit 4.
The primary endpoint will be the EAR PD20, the amount of allergen required to induce an early asthmatic response (i.e. a fall in FEV1 post allergen inhalation of 20% or more) tiotropium versus placebo.
- Conditions
- Allergic Asthma
- Being tested
- tiotropium bromide monohydrate (Spiriva Respimat), matching placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tiotropium bromide monohydrate (Spiriva Respimat)Drug
administered daily, 2 inhalations/5mcg per dose for a total of 8 doses
matching placeboDrug
administered daily, 2 inhalations per dose for a total of 8 doses
| Study group | Role | What they receive |
|---|---|---|
| tiotropium bromide monohydrate (Spiriva Respimat) | Experimental | Not described Receives: Drug: tiotropium bromide monohydrate (Spiriva Respimat) |
| matching placebo | Placebo comparator | Not described Receives: Drug: matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
EAR PD20
amount of inhaled allergen required to induce a 20% fall in FEV1
Measured: 30 minutes post last dose of treatment
Secondary outcomes (2)
Airway inflammation
level of FeNO (fractional exhaled nitric oxide) in parts per billion (ppb)
Measured: pre-treatment, 30 minutes post final dose and 5 hours post allergen inhalation challenge
Airway inflammation
change in number of sputum differential cell counts, specifically eosinophils
Measured: pre treatment and 5 hours post allergen inhalation challenge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2020
- Study start13 Nov 2020
- Primary completion20 Apr 2021
- Study completion20 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allergic 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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Saskatchewan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beth Davis, University of Saskatchewan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04648813
- Sponsor's protocol ID
- BIO REB 1959
- Status last verified
- Sep 2021
- First submitted
- 23 Nov 2020
- Last updated
- 30 Sep 2021
- 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 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tiotropium Efficacy Against Allergen Induced Early Asthmatic Responses
- ClinicalTrials.gov ID
- NCT04648813
- Acronym / sponsor ID
- BIO REB 1959
- Conditions
- Allergic Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of SaskatchewanUniversity, hospital or other
- Study start
- 13 Nov 2020 (actual)
- Primary completion
- 20 Apr 2021 (actual)
- Study completion
- 20 Apr 2021 (actual)
- First posted
- 2 Dec 2020 (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 compare the effect of inhaled tiotropium versus placebo on allergen induced early asthmatic responses in individuals with atopic asthma.
Detailed description
This is a single center, double-blind, randomized, placebo-controlled, crossover study. The study will consist of two one week treatment periods, one with tiotropium (two inhalations/5mcg/day) and one with placebo (2inhalations/day). A minimum two week washout period between treatments is required. Four visits over the course of approximately 4 weeks will be required to complete the study. Procedures at each visit are as follows:
Visit 1:
Participants will undergo consent procedures and if consent is provided measurements of FeNO, spirometry, airway responsiveness to methacholine, skin prick testing, skin titration endpoint testing and sputum induction will be performed. If participants meet eligibility criteria following these assessments, treatment 1 will be dispensed and the first dose administered. The participant will then self administer the treatment for the next six days (i.e. a total of 7 days of treatment) before returning for Visit 2.
Visit 2:
A final dose of treatment 1 will be administered. At 30 minutes post dose, FeNO testing, spirometry measurements and allergen inhalation challenge will be performed. Five hours after the allergen challenge, FeNO will again be measured and sputum induction will be performed.
Visits 3 and 4:
Visits 3 and 4 will be identical to Visit 1 and 2 except that no skin prick testing or skin titration endpoint testing will be required. At Visit 3 participants will be crossed over to treatment 2 and the first dose will be administered. Participants will self administer treatment 2 for the next six days before returning for Visit 4.
The primary endpoint will be the EAR PD20, the amount of allergen required to induce an early asthmatic response (i.e. a fall in FEV1 post allergen inhalation of 20% or more) tiotropium versus placebo.
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 monohydrate (Spiriva Respimat) | Experimental | Drug: tiotropium bromide monohydrate (Spiriva Respimat) |
| matching placebo | Placebo comparator | Drug: matching placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- signed informed consent
- diagnosis of mild asthma with a minimum 3 months history at the time of enrolment into the trial
- pre-bronchodilator FEV1 80% or greater than the predicted value
- positive response to inhaled methacholine (i.e. MCh PD20 ≤ 400mcg)
- evidence of atopy (i.e. positive skin prick test to an allergen that is appropriate for use in allergen inhalation challenge)
Key exclusion criteria (14 listed)
- currently pregnant or breast-feeding
- current daily use of other inhaled recreational products (e.g. cannabis, e-cigarettes or other vaping products; occasional use requires 24 hour withhold)
- diagnosis or evidence of narrow angle glaucoma
- diagnosis or evidence of urinary retention
- known hypersensitivity to tiotropium, atropine or its derivatives (e.g. ipratropium) or components of tiotropium formulation (e.g. benzalkonium chloride)
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 bromide monohydrate (Spiriva Respimat)administered daily, 2 inhalations/5mcg per dose for a total of 8 doses | Drug | tiotropium bromide monohydrate (Spiriva Respimat) |
| matching placeboadministered daily, 2 inhalations per dose for a total of 8 doses | Drug | matching placebo |
Primary outcome
EAR PD20
Time frame: 30 minutes post last dose of treatment
amount of inhaled allergen required to induce a 20% fall in FEV1
2 secondary outcomes
Airway inflammation
Time frame: pre-treatment, 30 minutes post final dose and 5 hours post allergen inhalation challenge
Airway inflammation
Time frame: pre treatment and 5 hours post allergen inhalation challenge
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 30 Sep 2021.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 monohydrate (Spiriva Respimat) in people with Allergic 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 10 inclusion and 14 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 30 Sep 2021. 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?
EAR PD20 (time frame: 30 minutes post last dose of treatment). 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 30 Sep 2021.