HealthyPhase 1NCT02172781
Comparative Pharmacokinetics and Pharmacodynamics of Tiotropium With Ipratropium or Placebo After 19 Days of Tiotropium Treatment
A Phase 1 study testing Ipratropium - unit dose vial and Tiotropium - inhalation capsule in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Comparative Pharmacokinetics and Pharmacodynamics of Tiotropium With Ipratropium or Placebo After 19 Days of Tiotropium Treatment Read more about this study
- Who is it for?
- Ages 40 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Ipratropium - unit dose vial and Tiotropium - inhalation capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Jan 2001to Apr 2001
- 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 40 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All participants in the study should be healthy males, ranging from 40 to 65 years of age and within ±20% of their normal weight (Broca-Index)
- Each subject will have his medical history taken and will receive a complete medical examination (including blood pressure and pulse rate measurements) as well as a 12-lead ECG.
- Haematological, hepatic and renal function tests will be carried out in the laboratory (Bioscentia GmbH, FRG). The subjects will fast for 8 hours before collection of specimens for all laboratory evaluations. The above mentioned examinations will be performed within 14 days before the first drug administration.
- In accordance with Good Clinical Practice (GCP) and local legislation all subjects will have given their written informed consent prior to admission to the study.
- Following inclusion criteria were of special interest for this study:
- Normal spirometry as evidenced by a baseline FEV1 ≥ 80% of predicted normal value for age, height and sex. Predicted normal values will be calculated according to European Community of Coal and Steel (ECCS)
- Ability to perform technically satisfactory pulmonary function tests.
Who cannot join
- Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance.
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders.
- History of orthostatic hypotension, fainting spells or blackouts.
- Chronic or relevant acute infections.
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator.
Show all 20Show fewer
- Intake of drugs with a long half-life (≥ 24hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study.
- Use of any drugs which might influence the results of the trial up to seven days prior to enrolment in the study or during the study, among these all non-selective beta blockers, oral beta adrenergics or long-acting beta-adrenergics such as salmeterol and formoterol, and anticholinergic drugs including ATROVENT ®(ipratropium) by oral inhalation and ATROVENT® Nasal Spray.
- Participation in another trial with an investigational drug (≤ two months prior to administration or during trial).
- Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day)
- Inability to refrain from smoking on trial days.
- Alcohol abuse (> 60g/day)
- Drug abuse
- Blood donation (≥ 100 ml within four weeks prior to administration or during the trial)
- Any laboratory value outside the clinically accepted reference range.
- Excessive physical activities (within the last week before and during the study)
- Following exclusion criteria are of special interest for the study:
- Subjects with known hypersensitivity to anticholinergic drugs.
- Subjects with known symptomatic prostatic hypertrophy or bladder neck obstruction
- Subjects with known narrow-angle glaucoma
About this study
Official title: A Double-blind, Randomised, Two-way Cross-over Study to Investigate the Pharmacokinetic and Pharmacodynamic Effects of a Single Additional Dose of 500 µg Ipratropium Bromide Unit Dose Vial Inhaled Via Nebuliser Versus Placebo After 19 Days of Treatment With Tiotropium Inhalation Capsules 18 µg q.d. in Male Healthy Volunteers.
Comparative Pharmacokinetics and Pharmacodynamics of Tiotropium With Ipratropium or Placebo After 19 Days of Tiotropium Treatment
- Conditions
- Healthy
- Being tested
- Ipratropium - unit dose vial, Tiotropium - inhalation capsule, Placebo matching tiotropium, Placebo matching ipratropium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ipratropium - unit dose vialDrug
Tiotropium - inhalation capsuleDrug
Placebo matching tiotropiumDrug
Placebo matching ipratropiumDrug
| Study group | Role | What they receive |
|---|---|---|
| Ipratropium - unit dose vial | Experimental | Not described Receives: Drug: Ipratropium - unit dose vial; Drug: Placebo matching ipratropium |
| Tiotropium - inhalation capsule - low dose | Experimental | Not described Receives: Drug: Ipratropium - unit dose vial; Drug: Tiotropium - inhalation capsule; Drug: Placebo matching tiotropium; Drug: Placebo matching ipratropium |
| Placebo matching tiotropium - inhalation capsule | Placebo comparator | Not described Receives: Drug: Ipratropium - unit dose vial; Drug: Tiotropium - inhalation capsule; Drug: Placebo matching tiotropium; Drug: Placebo matching ipratropium |
| Placebo matching to ipratropium - unit dose vial | Placebo comparator | Not described Receives: Drug: Ipratropium - unit dose vial; Drug: Tiotropium - inhalation capsule; Drug: Placebo matching tiotropium; Drug: Placebo matching ipratropium |
| Tiotropium - inhalation capsule - high dose | Experimental | Not described Receives: Drug: Ipratropium - unit dose vial; Drug: Tiotropium - inhalation capsule; Drug: Placebo matching ipratropium |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC - Area under the curve of the log-transformed value of salivary secretion after application of randomised treatment
Measured: over the interval from two hours to six hours on study day 19 and 22
Secondary outcomes (21)
Cmax (Peak (maximum) plasma concentration) - Tiotropium
Measured: Day1, day 7, day 19, day 22 ( before and different time points after dosing), day 2, day 3, day 20 (before dosing)
Cmax,ss (maximum observed concentration of the analyte in plasma at steady state) - Tiotropium
Measured: Day1, day 7, day 19, day 22 ( before and different time points after dosing), day 2, day 3, day 20 (before dosing)
Tmax (time to reach the peak plasma concentration) - Tiotropium
Measured: Day1, day 7, day 19, day 22 ( before and different time points after dosing), day 2, day 3, day 20 (before dosing)
Tmax, ss (Time to reach maximum concentration of the analyte in plasma at steady state) - Tiotropium
Measured: Day1, day 7, day 19, day 22 ( before and different time points after dosing), day 2, day 3, day 20 (before dosing)
Cpre (predose concentration of the analyte in plasma) -Tiotropium
Measured: Day1, day 7, day 19, day 22 ( before and different time points after dosing), day 2, day 3, day 20 (before dosing)
Cpre,ss (predose concentration of the analyte in plasma at steady state) - Tiotropium
Measured: Day1, day 7, day 19, day 22 ( before and different time points after dosing), day 2, day 3, day 20 (before dosing)
AUC (area under the concentration time curve of the analyte in plasma) - Tiotropium
Measured: Day1, day 7, day 19, day 22 ( before and different time points after dosing), day 2, day 3, day 20 (before dosing)
AUC,ss (area under the concentration time curve of the analyte in plasma at steady state) - Tiotropium
Measured: Day1, day 7, day 19, day 22 ( before and different time points after dosing), day 2, day 3, day 20 (before dosing)
Ae (amount of analyte that is eliminated in urine) - Tiotropium
Measured: Day1, day 7, day 19, day 22 ( before and different time points after dosing), day 2, day 3, day 20 (before dosing)
CLR (renal clearance of the analyte) - Tiotropium
Measured: Day1, day 7, day 19, day 22 ( before and different time points after dosing), day 2, day 3, day 20 (before dosing)
Cmax (Peak (maximum) plasma concentration) - Ipratropium
Measured: Day A1, A4 (before and after inhalation of ipratropium), day 19, day 22 (before, at end of ipratropium inhalation and different time points after tiotropium dosing), day 20 (10 min.before tiotropium dosing)
Tmax (time to reach the peak plasma concentration) - Ipratropium
Measured: Day A1, A4 (before and after inhalation of ipratropium), day 19, day 22 (before, at end of ipratropium inhalation and different time points after tiotropium dosing), day 20 (10 min.before tiotropium dosing)
AUC (area under the concentration time curve of the analyte in plasma) - Ipratropium
Measured: Day A1, A4 (before and after inhalation of ipratropium), day 19, day 22 (before, at end of ipratropium inhalation and different time points after tiotropium dosing), day 20 (10 min.before tiotropium dosing)
Ae (amount of analyte that is eliminated in urine) - Ipratropium
Measured: Day A1, A4 (before and after inhalation of ipratropium), day 19, day 22 (before, at end of ipratropium inhalation and different time points after tiotropium dosing), day 20 (10 min.before tiotropium dosing)
CLR (renal clearance of the analyte) - Ipratropium
Measured: Day A1, A4 (before and after inhalation of ipratropium), day 19, day 22 (before, at end of ipratropium inhalation and different time points after tiotropium dosing), day 20 (10 min.before tiotropium dosing)
Amount of Salivary secretion
Measured: Screening, A1, A4 ( before and after dosing of ipratropium), different time points at day 1, day 2, day 7, day 19 and 22 (before and after dosing of tiotropium and Ipratropium), day 20, day 23
FEV1 (Forced expiratory volume in one second)
Measured: Screening, A1, A4 ( before and after dosing of ipratropium), different time points at day 1, day 2, day 7, day 19 and 22 (before and after dosing of tiotropium and Ipratropium), day 20, day 23
FVC (Forced vital capacity)
Measured: Screening, A1, A4 ( before and after dosing of ipratropium), different time points at day 1, day 2, day 7, day 19 and 22 (before and after dosing of tiotropium and Ipratropium), day 20, day 23
MMEF25-75% (maximal mid-expiratory flow)
Measured: Screening, A1, A4 ( before and after dosing of ipratropium), different time points at day 1, day 2, day 7, day 19 and 22 (before and after dosing of tiotropium and Ipratropium), day 20, day 23
PEFR (peak expiratory flow rate)
Measured: Screening, A1, A4 ( before and after dosing of ipratropium), different time points at day 1, day 2, day 7, day 19 and 22 (before and after dosing of tiotropium and Ipratropium), day 20, day 23
Occurence of adverse events
Measured: Screening, A1-A6, B1-B23, end of study (within 8 days after last dosing tiotropium)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startJan 2001
- Primary completionApr 2001
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
- Crossover
- Masking
- Double blind
- Enrolment
- 36 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
- NCT02172781
- Sponsor's protocol ID
- 205.239
- Status last verified
- Jun 2014
- First submitted
- 20 Jun 2014
- Last updated
- 24 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomised, Two-way Cross-over Study to Investigate the Pharmacokinetic and Pharmacodynamic Effects of a Single Additional Dose of 500 µg Ipratropium Bromide Unit Dose Vial Inhaled Via Nebuliser Versus Placebo After 19 Days of Treatment With Tiotropium Inhalation Capsules 18 µg q.d. in Male Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT02172781
- Acronym / sponsor ID
- 205.239
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 2001
- Primary completion
- Apr 2001 (actual)
- First posted
- 24 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.
Comparative Pharmacokinetics and Pharmacodynamics of Tiotropium With Ipratropium or Placebo After 19 Days of Tiotropium Treatment
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Ipratropium - unit dose vial | Experimental | Drug: Ipratropium - unit dose vial, Drug: Placebo matching ipratropium |
| Tiotropium - inhalation capsule - low dose | Experimental | Drug: Ipratropium - unit dose vial, Drug: Tiotropium - inhalation capsule, Drug: Placebo matching tiotropium, Drug: Placebo matching ipratropium |
| Placebo matching tiotropium - inhalation capsule | Placebo comparator | Drug: Ipratropium - unit dose vial, Drug: Tiotropium - inhalation capsule, Drug: Placebo matching tiotropium, Drug: Placebo matching ipratropium |
| Placebo matching to ipratropium - unit dose vial | Placebo comparator | Drug: Ipratropium - unit dose vial, Drug: Tiotropium - inhalation capsule, Drug: Placebo matching tiotropium, Drug: Placebo matching ipratropium |
| Tiotropium - inhalation capsule - high dose | Experimental | Drug: Ipratropium - unit dose vial, Drug: Tiotropium - inhalation capsule, Drug: Placebo matching ipratropium |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- All participants in the study should be healthy males, ranging from 40 to 65 years of age and within ±20% of their normal weight (Broca-Index)
- Each subject will have his medical history taken and will receive a complete medical examination (including blood pressure and pulse rate measurements) as well as a 12-lead ECG.
- Haematological, hepatic and renal function tests will be carried out in the laboratory (Bioscentia GmbH, FRG). The subjects will fast for 8 hours before collection of specimens for all laboratory evaluations. The above mentioned examinations will be performed within 14 days before the first drug administration.
- In accordance with Good Clinical Practice (GCP) and local legislation all subjects will have given their written informed consent prior to admission to the study.
- Normal spirometry as evidenced by a baseline FEV1 ≥ 80% of predicted normal value for age, height and sex. Predicted normal values will be calculated according to European Community of Coal and Steel (ECCS)
Key exclusion criteria (20 listed)
- Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance.
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders.
- Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders.
- History of orthostatic hypotension, fainting spells or blackouts.
- 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 |
|---|---|---|
| Ipratropium - unit dose vial | Drug | Ipratropium - unit dose vial, Placebo matching tiotropium - inhalation capsule, Placebo matching to ipratropium - unit dose vial, Tiotropium - inhalation capsule - high dose, Tiotropium - inhalation capsule - low dose |
| Tiotropium - inhalation capsule | Drug | Placebo matching tiotropium - inhalation capsule, Placebo matching to ipratropium - unit dose vial, Tiotropium - inhalation capsule - high dose, Tiotropium - inhalation capsule - low dose |
| Placebo matching tiotropium | Drug | Placebo matching tiotropium - inhalation capsule, Placebo matching to ipratropium - unit dose vial, Tiotropium - inhalation capsule - low dose |
| Placebo matching ipratropium | Drug | Ipratropium - unit dose vial, Placebo matching tiotropium - inhalation capsule, Placebo matching to ipratropium - unit dose vial, Tiotropium - inhalation capsule - high dose, Tiotropium - inhalation capsule - low dose |
Primary outcome
AUC - Area under the curve of the log-transformed value of salivary secretion after application of randomised treatment
Time frame: over the interval from two hours to six hours on study day 19 and 22
21 secondary outcomes
Cmax (Peak (maximum) plasma concentration) - Tiotropium
Time frame: Day1, day 7, day 19, day 22 ( before and different time points after dosing), day 2, day 3, day 20 (before dosing)
Cmax,ss (maximum observed concentration of the analyte in plasma at steady state) - Tiotropium
Time frame: Day1, day 7, day 19, day 22 ( before and different time points after dosing), day 2, day 3, day 20 (before dosing)
Tmax (time to reach the peak plasma concentration) - Tiotropium
Time frame: Day1, day 7, day 19, day 22 ( before and different time points after dosing), day 2, day 3, day 20 (before dosing)
Tmax, ss (Time to reach maximum concentration of the analyte in plasma at steady state) - Tiotropium
Time frame: Day1, day 7, day 19, day 22 ( before and different time points after dosing), day 2, day 3, day 20 (before dosing)
Cpre (predose concentration of the analyte in plasma) -Tiotropium
Time frame: Day1, day 7, day 19, day 22 ( before and different time points after dosing), day 2, day 3, day 20 (before dosing)
Cpre,ss (predose concentration of the analyte in plasma at steady state) - Tiotropium
Time frame: Day1, day 7, day 19, day 22 ( before and different time points after dosing), day 2, day 3, day 20 (before dosing)
AUC (area under the concentration time curve of the analyte in plasma) - Tiotropium
Time frame: Day1, day 7, day 19, day 22 ( before and different time points after dosing), day 2, day 3, day 20 (before dosing)
AUC,ss (area under the concentration time curve of the analyte in plasma at steady state) - Tiotropium
Time frame: Day1, day 7, day 19, day 22 ( before and different time points after dosing), day 2, day 3, day 20 (before dosing)
Ae (amount of analyte that is eliminated in urine) - Tiotropium
Time frame: Day1, day 7, day 19, day 22 ( before and different time points after dosing), day 2, day 3, day 20 (before dosing)
CLR (renal clearance of the analyte) - Tiotropium
Time frame: Day1, day 7, day 19, day 22 ( before and different time points after dosing), day 2, day 3, day 20 (before dosing)
Cmax (Peak (maximum) plasma concentration) - Ipratropium
Time frame: Day A1, A4 (before and after inhalation of ipratropium), day 19, day 22 (before, at end of ipratropium inhalation and different time points after tiotropium dosing), day 20 (10 min.before tiotropium dosing)
Tmax (time to reach the peak plasma concentration) - Ipratropium
Time frame: Day A1, A4 (before and after inhalation of ipratropium), day 19, day 22 (before, at end of ipratropium inhalation and different time points after tiotropium dosing), day 20 (10 min.before tiotropium dosing)
AUC (area under the concentration time curve of the analyte in plasma) - Ipratropium
Time frame: Day A1, A4 (before and after inhalation of ipratropium), day 19, day 22 (before, at end of ipratropium inhalation and different time points after tiotropium dosing), day 20 (10 min.before tiotropium dosing)
Ae (amount of analyte that is eliminated in urine) - Ipratropium
Time frame: Day A1, A4 (before and after inhalation of ipratropium), day 19, day 22 (before, at end of ipratropium inhalation and different time points after tiotropium dosing), day 20 (10 min.before tiotropium dosing)
CLR (renal clearance of the analyte) - Ipratropium
Time frame: Day A1, A4 (before and after inhalation of ipratropium), day 19, day 22 (before, at end of ipratropium inhalation and different time points after tiotropium dosing), day 20 (10 min.before tiotropium dosing)
Amount of Salivary secretion
Time frame: Screening, A1, A4 ( before and after dosing of ipratropium), different time points at day 1, day 2, day 7, day 19 and 22 (before and after dosing of tiotropium and Ipratropium), day 20, day 23
FEV1 (Forced expiratory volume in one second)
Time frame: Screening, A1, A4 ( before and after dosing of ipratropium), different time points at day 1, day 2, day 7, day 19 and 22 (before and after dosing of tiotropium and Ipratropium), day 20, day 23
FVC (Forced vital capacity)
Time frame: Screening, A1, A4 ( before and after dosing of ipratropium), different time points at day 1, day 2, day 7, day 19 and 22 (before and after dosing of tiotropium and Ipratropium), day 20, day 23
MMEF25-75% (maximal mid-expiratory flow)
Time frame: Screening, A1, A4 ( before and after dosing of ipratropium), different time points at day 1, day 2, day 7, day 19 and 22 (before and after dosing of tiotropium and Ipratropium), day 20, day 23
PEFR (peak expiratory flow rate)
Time frame: Screening, A1, A4 ( before and after dosing of ipratropium), different time points at day 1, day 2, day 7, day 19 and 22 (before and after dosing of tiotropium and Ipratropium), day 20, day 23
Occurence of adverse events
Time frame: Screening, A1-A6, B1-B23, end of study (within 8 days after last dosing tiotropium)
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 24 Jun 2014.
- Related InfoLink provided by the sponsor.
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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 Ipratropium - unit dose vial and Tiotropium - inhalation capsule 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 7 inclusion and 20 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 24 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. 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 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?
AUC - Area under the curve of the log-transformed value of salivary secretion after application of randomised treatment (time frame: over the interval from two hours to six hours on study day 19 and 22). 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 24 Jun 2014.