HealthyPhase 1NCT02177305
Dose Tolerance Study After Ocular Administration of Tiotropium in Healthy Male Volunteers
A Phase 1 study testing 0.02 mcg tiotropium solution, 0.04 mcg tiotropium solution and 0.08 mcg tiotropium solution in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Safety and tolerability after ocular administration Read more about this study
- Who is it for?
- Ages 21 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 0.02 mcg tiotropium solution, 0.04 mcg tiotropium solution and 0.08 mcg tiotropium solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Oct 1998to Dec 1998
- 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 21 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males
- Age range from 21 to 50 years
- Within ± 20% of normal weight (Broca-Index)
- Written informed consent given
Who cannot join
- Results of the medical examinations or laboratory tests are judged by the clinical investigator to differ significantly from normal clinical values
- Volunteers with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Volunteers with disease of the central nervous system (such as epilepsy) or with psychiatric disorders
- Volunteers with known history of orthostatic hypotension, fainting spells or blackouts
- Volunteers with chronic or relevant acute infections
- Volunteers with history of allergy/ hypersensitivity (including drug allergy)
Show all 19Show fewer
- Volunteers with known eye diseases (incl. glaucoma), with hyperopia (> 3 diopters) or with contact lenses
- Volunteers with intraocular pressure > 22 mmHg
- Volunteers with predisposition to narrow-angle glaucoma
- Volunteers with disturbed micturition
- Volunteers who have taken a drug with a long half-life (≥ 24 hours) within ten half-lives of the respective drug before enrolment in the study
- Volunteers who received any other drugs which might influence the results of the trial during the week previous the start of the study
- Volunteers who have participated in another study with an investigational drug within the last two months preceding this study
- Volunteers who smoke (> 10 cigarettes or 3 cigars or 3 pipes/day)
- Volunteers who are not able to refrain from smoking on study day
- Volunteers who drink more than 40 g of alcohol per day
- Volunteers who are dependent on drugs
- Volunteers who have donated blood (≥ 100 ml) within the last four weeks
- Volunteers who participated in excessive physical activities (e.g. competitive sports) within the last week before the study
About this study
Official title: A Single Increasing Dose Tolerance Study After Ocular Administration of Tiotropium (Single Doses: 0.02 - 0.4 mcg) in Healthy Male Volunteers (Randomised, Placebo-controlled, Double-blind, Parallel Groups).
Safety and tolerability after ocular administration
- Conditions
- Healthy
- Being tested
- 0.02 mcg tiotropium solution, 0.04 mcg tiotropium solution, 0.08 mcg tiotropium solution, 0.16 mcg tiotropium solution, 0.28 mcg tiotropium solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.02 mcg tiotropium solutionDrug
0.04 mcg tiotropium solutionDrug
0.08 mcg tiotropium solutionDrug
0.16 mcg tiotropium solutionDrug
0.28 mcg tiotropium solutionDrug
0.40 mcg tiotropium solutionDrug
Placebo solutionDrug
| Study group | Role | What they receive |
|---|---|---|
| Tiotropium dose group 1 | Experimental | 0.02 mcg tiotropium solution Receives: Drug: 0.02 mcg tiotropium solution; Drug: Placebo solution |
| Tiotropium dose group 2 | Experimental | 0.04 mcg tiotropium solution Receives: Drug: 0.04 mcg tiotropium solution; Drug: Placebo solution |
| Tiotropium dose group 3 | Experimental | 0.08 mcg tiotropium solution Receives: Drug: 0.08 mcg tiotropium solution; Drug: Placebo solution |
| Tiotropium dose group 4 | Experimental | 0.16 mcg tiotropium solution Receives: Drug: 0.16 mcg tiotropium solution; Drug: Placebo solution |
| Tiotropium dose group 5 | Experimental | 0.28 mcg tiotropium solution Receives: Drug: 0.28 mcg tiotropium solution; Drug: Placebo solution |
| Tiotropium dose group 6 | Experimental | 0.40 mcg tiotropium solution Receives: Drug: 0.40 mcg tiotropium solution; Drug: Placebo solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pupil diameter
Measured: baseline, after 24 hours
Change in pupillary reflex
Measured: baseline, after 24 hours
Change in intraocular pressure
Measured: baseline, after 24 hours
Change in accommodation
Measured: baseline, after 24 hours
Secondary outcomes (5)
Change from baseline in blood pressure
Measured: on Day 1 before and 24 hours after treatment and within 8 days after treatment day
Change from baseline in pulse rate
Measured: on Day 1 before and 24 hours after treatment and within 8 days after treatment day
Change in 12-lead ECG
Measured: on Day 1 before and 24 hours after treatment and within 8 days after treatment day
Changes from baseline in standard laboratory examinations
Measured: Baseline and within 8 days after treatment day
Occurrence of Adverse Events
Measured: until 8 days after treatment day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study startOct 1998
- Primary completionDec 1998
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02177305
- Sponsor's protocol ID
- 205.138
- Status last verified
- Jun 2014
- First submitted
- 20 Jun 2014
- Last updated
- 27 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Increasing Dose Tolerance Study After Ocular Administration of Tiotropium (Single Doses: 0.02 - 0.4 mcg) in Healthy Male Volunteers (Randomised, Placebo-controlled, Double-blind, Parallel Groups).
- ClinicalTrials.gov ID
- NCT02177305
- Acronym / sponsor ID
- 205.138
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Oct 1998
- Primary completion
- Dec 1998 (actual)
- First posted
- 27 Jun 2014 (estimated)
- 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.
Safety and tolerability after ocular administration
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Tiotropium dose group 1 | Experimental | Drug: 0.02 mcg tiotropium solution, Drug: Placebo solution0.02 mcg tiotropium solution |
| Tiotropium dose group 2 | Experimental | Drug: 0.04 mcg tiotropium solution, Drug: Placebo solution0.04 mcg tiotropium solution |
| Tiotropium dose group 3 | Experimental | Drug: 0.08 mcg tiotropium solution, Drug: Placebo solution0.08 mcg tiotropium solution |
| Tiotropium dose group 4 | Experimental | Drug: 0.16 mcg tiotropium solution, Drug: Placebo solution0.16 mcg tiotropium solution |
| Tiotropium dose group 5 | Experimental | Drug: 0.28 mcg tiotropium solution, Drug: Placebo solution0.28 mcg tiotropium solution |
| Tiotropium dose group 6 | Experimental | Drug: 0.40 mcg tiotropium solution, Drug: Placebo solution0.40 mcg tiotropium solution |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy males
- Age range from 21 to 50 years
- Within ± 20% of normal weight (Broca-Index)
- Written informed consent given
Key exclusion criteria (19 listed)
- Results of the medical examinations or laboratory tests are judged by the clinical investigator to differ significantly from normal clinical values
- Volunteers with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Volunteers with disease of the central nervous system (such as epilepsy) or with psychiatric disorders
- Volunteers with known history of orthostatic hypotension, fainting spells or blackouts
- Volunteers with chronic or relevant acute infections
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 |
|---|---|---|
| 0.02 mcg tiotropium solution | Drug | Tiotropium dose group 1 |
| 0.04 mcg tiotropium solution | Drug | Tiotropium dose group 2 |
| 0.08 mcg tiotropium solution | Drug | Tiotropium dose group 3 |
| 0.16 mcg tiotropium solution | Drug | Tiotropium dose group 4 |
| 0.28 mcg tiotropium solution | Drug | Tiotropium dose group 5 |
| 0.40 mcg tiotropium solution | Drug | Tiotropium dose group 6 |
| Placebo solution | Drug | Tiotropium dose group 1, Tiotropium dose group 2, Tiotropium dose group 3, Tiotropium dose group 4, Tiotropium dose group 5, Tiotropium dose group 6 |
Primary outcome
Change in pupil diameter
Time frame: baseline, after 24 hours
Change in pupillary reflex
Time frame: baseline, after 24 hours
Change in intraocular pressure
Time frame: baseline, after 24 hours
Change in accommodation
Time frame: baseline, after 24 hours
5 secondary outcomes
Change from baseline in blood pressure
Time frame: on Day 1 before and 24 hours after treatment and within 8 days after treatment day
Change from baseline in pulse rate
Time frame: on Day 1 before and 24 hours after treatment and within 8 days after treatment day
Change in 12-lead ECG
Time frame: on Day 1 before and 24 hours after treatment and within 8 days after treatment day
Changes from baseline in standard laboratory examinations
Time frame: Baseline and within 8 days after treatment day
Occurrence of Adverse Events
Time frame: until 8 days after treatment day
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 27 Jun 2014.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 0.02 mcg tiotropium solution, 0.04 mcg tiotropium solution and 0.08 mcg tiotropium solution in people with Healthy, run by Boehringer Ingelheim.
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 19 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 27 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in pupil diameter (time frame: baseline, after 24 hours). The study lists 4 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 27 Jun 2014.