Healthy VolunteersPhase 1TESSANCT04850144
Pharmacokinetic Study Comparing Tiotropium Easyhaler® and Spiriva® HandiHaler®
A Phase 1 study testing Tiotropium Bromide Monohydrate and Tiotropium Easyhaler with oral activated charcoal in people with Healthy Volunteers, run by Orion Corporation, Orion Pharma at 1 site in Finland.
Trial summary
Absorption of inhaled tiotropium is compared between five Tiotropium Easyhaler product variants and Spiriva capsules inhaled via HandiHaler without charcoal. Absorption of tiotropium is compared between one Easyhaler product variant administered with and without charcoal. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Tiotropium Bromide Monohydrate and Tiotropium Easyhaler with oral activated charcoal
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteFinland
- Study dates
- 26 Apr 2021to 4 Oct 2021
- Phase
- Phase 1
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Main inclusion criteria:
- Healthy males and females
- 18-60 years of age
- Body mass index 19-30 kg/m2
- Weight at least 50 kg
- Written informed consent obtained
Main exclusion criteria:
- Evidence of a clinically significant cardiovascular, renal, hepatic, haematological, gastrointestinal, pulmonary, metabolic, endocrine, neurological or psychiatric disease
- Any condition requiring regular concomitant treatment
- Any clinically significant abnormal laboratory value or physical finding that in the opinion of the investigator could interfere with the interpretation of study results or cause a health risk for the subject
- Known hypersensitivity to tiotropium bromide, atropine or its derivatives or lactose
- Pregnant or lactating females and females of childbearing potential not using contraception of acceptable effectiveness
- Blood donation or loss of significant amount of blood within 90 days prior to the first study treatment administration.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Tiotropium Pharmacokinetics After Inhalation From Tiotropium Easyhaler® Product Variants and After Spiriva® Capsules Administered Via HandiHaler®; Study in Healthy Volunteers
Absorption of inhaled tiotropium is compared between five Tiotropium Easyhaler product variants and Spiriva capsules inhaled via HandiHaler without charcoal. Absorption of tiotropium is compared between one Easyhaler product variant administered with and without charcoal.
- Conditions
- Healthy Volunteers
- Being tested
- Tiotropium Bromide Monohydrate, Tiotropium Easyhaler with oral activated charcoal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tiotropium Bromide MonohydrateDrug
Tiotropium Easyhaler 10 µg/dose Product variant D
Tiotropium Bromide MonohydrateDrug
Tiotropium Easyhaler 10 µg/dose Product variant E
Tiotropium Bromide MonohydrateDrug
Tiotropium Easyhaler 10 µg/dose Product variant F
Tiotropium Bromide MonohydrateDrug
Tiotropium Easyhaler 10 µg/dose Product variant G
Tiotropium Bromide MonohydrateDrug
Tiotropium Easyhaler 10 µg/dose Product variant H
Tiotropium Bromide MonohydrateDrug
Spiriva 18 µg/capsule inhaled via Handihaler
Tiotropium Easyhaler with oral activated charcoalDrug
The charcoal suspension will be administered orally with Tiotropium Easyhaler 10 µg/dose Product variant F
| Study group | Role | What they receive |
|---|---|---|
| Tiotropium Easyhaler Product variant D | Experimental | Not described Receives: Drug: Tiotropium Bromide Monohydrate |
| Tiotropium Easyhaler Product variant E | Experimental | Not described Receives: Drug: Tiotropium Bromide Monohydrate |
| Tiotropium Easyhaler Product variant F | Experimental | Not described Receives: Drug: Tiotropium Bromide Monohydrate |
| Tiotropium Easyhaler Product variant G | Experimental | Not described Receives: Drug: Tiotropium Bromide Monohydrate |
| Tiotropium Easyhaler Product variant H | Experimental | Not described Receives: Drug: Tiotropium Bromide Monohydrate |
| Spiriva HandiHaler | Active comparator | Not described Receives: Drug: Tiotropium Bromide Monohydrate |
| Tiotropium Easyhaler Product variant F administered with oral activated charcoal | Experimental | Not described Receives: Drug: Tiotropium Bromide Monohydrate; Drug: Tiotropium Easyhaler with oral activated charcoal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak tiotropium concentration in plasma (Cmax)
Measured: between 0-72 hours after dosing
Area under the concentration-time curve from time zero to 30 minutes (AUC30 minutes)
Measured: 0-30 minutes after dosing
Area under the concentration-time curve from time zero to 72 hours (AUC72 hours)
Measured: 0-72 hours after dosing
Secondary outcomes (1)
Time to reach peak concentration in plasma (tmax)
Measured: between 0-72 hours after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start26 Apr 2021
- Primary completion4 Oct 2021
- Study completion4 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The study is a 2-part 4-period crossover study where the study subjects participate either in part 1 (20 subjects) or in part 2 (20 subjects). Parts can run in sequence or parallel. All study subjects receive single dose of Tiotropium Easyhaler on 3 periods and Spiriva HandiHaler on 1 period.
- Masking
- None (open label)
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orion Corporation, Orion Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Orion Corporation Clinical Study Director, Study director, Orion Corporation, Orion Pharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04850144
- Sponsor's protocol ID
- 3122005
- Acronym
- TESSA
- Status last verified
- Oct 2021
- First submitted
- 13 Apr 2021
- Last updated
- 25 Oct 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 25 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Tiotropium Pharmacokinetics After Inhalation From Tiotropium Easyhaler® Product Variants and After Spiriva® Capsules Administered Via HandiHaler®; Study in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04850144
- Acronym / sponsor ID
- TESSA / 3122005
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Orion Corporation, Orion PharmaIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2021 (actual)
- Primary completion
- 4 Oct 2021 (actual)
- Study completion
- 4 Oct 2021 (actual)
- First posted
- 20 Apr 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.
Absorption of inhaled tiotropium is compared between five Tiotropium Easyhaler product variants and Spiriva capsules inhaled via HandiHaler without charcoal. Absorption of tiotropium is compared between one Easyhaler product variant administered with and without charcoal.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 7
- Model description
- The study is a 2-part 4-period crossover study where the study subjects participate either in part 1 (20 subjects) or in part 2 (20 subjects). Parts can run in sequence or parallel. All study subjects receive single dose of Tiotropium Easyhaler on 3 periods and Spiriva HandiHaler on 1 period.
| Arm | Type | Receives |
|---|---|---|
| Tiotropium Easyhaler Product variant D | Experimental | Drug: Tiotropium Bromide Monohydrate |
| Tiotropium Easyhaler Product variant E | Experimental | Drug: Tiotropium Bromide Monohydrate |
| Tiotropium Easyhaler Product variant F | Experimental | Drug: Tiotropium Bromide Monohydrate |
| Tiotropium Easyhaler Product variant G | Experimental | Drug: Tiotropium Bromide Monohydrate |
| Tiotropium Easyhaler Product variant H | Experimental | Drug: Tiotropium Bromide Monohydrate |
| Spiriva HandiHaler | Active comparator | Drug: Tiotropium Bromide Monohydrate |
| Tiotropium Easyhaler Product variant F administered with oral activated charcoal | Experimental | Drug: Tiotropium Bromide Monohydrate, Drug: Tiotropium Easyhaler with oral activated charcoal |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 MonohydrateTiotropium Easyhaler 10 µg/dose Product variant D | Drug | Tiotropium Easyhaler Product variant D |
| Tiotropium Bromide MonohydrateTiotropium Easyhaler 10 µg/dose Product variant E | Drug | Tiotropium Easyhaler Product variant E |
| Tiotropium Bromide MonohydrateTiotropium Easyhaler 10 µg/dose Product variant F | Drug | Tiotropium Easyhaler Product variant F, Tiotropium Easyhaler Product variant F administered with oral activated charcoal |
| Tiotropium Bromide MonohydrateTiotropium Easyhaler 10 µg/dose Product variant G | Drug | Tiotropium Easyhaler Product variant G |
| Tiotropium Bromide MonohydrateTiotropium Easyhaler 10 µg/dose Product variant H | Drug | Tiotropium Easyhaler Product variant H |
| Tiotropium Bromide MonohydrateSpiriva 18 µg/capsule inhaled via Handihaler | Drug | Spiriva HandiHaler |
| Tiotropium Easyhaler with oral activated charcoalThe charcoal suspension will be administered orally with Tiotropium Easyhaler 10 µg/dose Product variant F | Drug | Tiotropium Easyhaler Product variant F administered with oral activated charcoal |
Primary outcome
Peak tiotropium concentration in plasma (Cmax)
Time frame: between 0-72 hours after dosing
Area under the concentration-time curve from time zero to 30 minutes (AUC30 minutes)
Time frame: 0-30 minutes after dosing
Area under the concentration-time curve from time zero to 72 hours (AUC72 hours)
Time frame: 0-72 hours after dosing
1 secondary outcome
Time to reach peak concentration in plasma (tmax)
Time frame: between 0-72 hours after dosing
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 25 Oct 2021.
- Individual participant dataSharing planned: No
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Healthy Participants
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.
Orion Corporation Clinical Study Director study director
Orion Corporation, Orion Pharma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tiotropium Bromide Monohydrate and Tiotropium Easyhaler with oral activated charcoal in people with Healthy Volunteers, run by Orion Corporation, Orion Pharma at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 25 Oct 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 Finland. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Peak tiotropium concentration in plasma (Cmax) (time frame: between 0-72 hours after dosing). 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 25 Oct 2021.