HealthyPhase 1NCT02254174
Relative Bioavailability of Tiotropium and Salmeterol After Inhalation of a Fixed Combined Dose Compared to Monocomponents in Healthy Male Volunteers
A Phase 1 study testing Tiotropium/Salmeterol, Serevent® Diskus® and Spiriva® in people with Healthy, run by Boehringer Ingelheim.
Trial summary
Assessment of the relative bioavailability of a fixed dose combination of tiotropium and salmeterol compared to a free dose combination of the marketed products of tiotropium and salmeterol (Spiriva® and Serevent® Diskus®). 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?
- Tiotropium/Salmeterol, Serevent® Diskus® and Spiriva®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Mar 2006to Jul 2006
- 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 male based upon a complete medical history, including the physical examination, regarding vital signs (blood pressure (BP), pulse rate (PR)), 12-lead ECG (electrocardiogram) measurement, and clinical laboratory tests. There is no finding deviating from normal and of clinical relevance.
- There is no evidence of a clinically relevant concomitant disease
- Age ≥21 and ≤50 years
- BMI ≥18.5 and <30 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation
Who cannot join
- Any finding of the medical examination (including BP, PR, and ECG measurements) deviating from normal and of clinical relevance
- Evidence of a clinically relevant concomitant disease
- 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 relevant orthostatic hypotension, fainting spells or blackouts
- Chronic or relevant acute infections
Show all 26Show fewer
- History of relevant allergy/hypersensitivity (including allergy to the drug or its excipients) as judged clinically relevant by the investigator
- Intake of drugs with a long half-life (>24 hours) within at least 1 month or less than 10 half-lives of the respective drug prior to randomisation
- Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to enrolment in the study or during the study
- Participation in another trial with an investigational drug within 2 months prior to randomisation
- Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)
- Inability to refrain from smoking on trial days as judged by the investigator
- Alcohol abuse (more than 40 g alcohol a day)
- Drug abuse
- Blood donation (more than 100 mL blood within 4 weeks prior to randomisation or during the trial)
- Excessive physical activities within 1 week prior to randomisation or during the trial
- Any laboratory value outside the reference range that is of clinical relevance
- Inability to comply with dietary regimen of the study centre
- The following exclusion criteria are specific for this study due to the known class side effect profile of ß2-mimetics:
- Asthma or history of pulmonary hyperreactivity
- Hyperthyrosis
- Allergic rhinitis in need of treatment
- Clinically relevant cardiac arrhythmia
- Paroxysmal tachycardia (>100 beats per minute)
- The following exclusion criteria are specific for this study due to the known class side effect profile of tiotropium:
- Hypersensitivity to tiotropium and/or related drugs of this class
About this study
Official title: A Randomised, Open-label Four-way Crossover Study to Evaluate Relative Bioavailability of Tiotropium and Salmeterol After Inhalation of a Fixed Combined Single Dose (7.5 μg Tiotropium, 25 μg Salmeterol, Inhalation Powder, Hard Capsule, HandiHaler®2), a Free Combined Single Dose of 18 μg Tiotropium [Spiriva® HandiHaler®] and 50 μg Salmeterol [Serevent® Diskus®], a Single Dose of 50μg Salmeterol (Serevent® Diskus®) and a Single Dose of 18 μg Tiotropium (Spiriva® HandiHaler®) in Healthy Male Volunteers
Assessment of the relative bioavailability of a fixed dose combination of tiotropium and salmeterol compared to a free dose combination of the marketed products of tiotropium and salmeterol (Spiriva® and Serevent® Diskus®).
Assessment of the relative bioavailability of a fixed dose combination of tiotropium and salmeterol compared to tiotropium and salmeterol administered as individual mono substances from the marketed products.
Assessment of safety and tolerability of the fixed combination of tiotropium and salmeterol in a PE (Polyethylene) capsule administered via the HandiHaler® 2
- Conditions
- Healthy
- Being tested
- Tiotropium/Salmeterol, Serevent® Diskus®, Spiriva®
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tiotropium/SalmeterolDrug
Fixed dose combination of tiotropium 7.5 μg and salmeterol 25 μg inhalation powder, PE capsule via HandiHaler®
Serevent® Diskus®Drug
Spiriva®Drug
| Study group | Role | What they receive |
|---|---|---|
| Tiotropium/Salmeterol | Experimental | Not described Receives: Drug: Tiotropium/Salmeterol |
| Serevent® Diskus® | Active comparator | Not described Receives: Drug: Serevent® Diskus® |
| Spiriva® | Active comparator | Not described Receives: Drug: Spiriva® |
| Spiriva® and Serevent® Diskus® | Active comparator | Not described Receives: Drug: Serevent® Diskus®; Drug: Spiriva® |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-∞ (area under the concentration-time curve of salmeterol in blood plasma over the time interval from 0 extrapolated to infinity);
Measured: Up to 8 hours after drug administration
Cmax (maximum measured concentration of salmeterol in blood plasma)
Measured: Up to 8 hours after drug administration
Ae0-8 (urinary excretion of tiotropium over an 8 hour interval)
Measured: Up to 8 hours after drug administration
Secondary outcomes (19)
AUC0-tz (area under the concentration-time curve in plasma over the time interval from 0 to the time of the last quantifiable data point)
Measured: Up to 8 hours after drug administration
AUC0-∞ (area under the concentration-time curve of tiotropium in blood plasma over the time interval from 0 extrapolated to infinity)
Measured: Up to 8 hours after drug administration
Cmax (maximum measured concentration of tiotropium in blood plasma)
Measured: Up to 8 hours after drug administration
AUCt1-t2 (area under the concentration time curve in plasma over the time interval t1 to t2)
Measured: up to 8 hours after inhalation
tmax (time from dosing to the maximum concentration of in plasma)
Measured: Up to 8 hours after drug administration
λz (terminal rate constant in plasma)
Measured: Up to 8 hours after drug administration
t½ (terminal half-life of in plasma)
Measured: Up to 8 hours after drug administration
MRTih (mean residence time in the body after inhalational administration)
Measured: Up to 8 hours after drug administration
CL/F (apparent clearance of in the plasma after extravascular administration)
Measured: Up to 8 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Measured: Up to 8 hours after drug administration
Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2
Measured: up to 8 hours after inhalation
fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
Measured: up to 8 hours after inhalation
CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)
Measured: up to 8 hours after inhalation
Number of participants with abnormal findings in physical examination
Measured: up to 90 days after first drug administration
Number of participants with clinically significant changes in vital signs
Measured: up to 90 days after first drug administration
Number of participants with abnormal findings in 12-lead ECG
Measured: up to 90 days after first drug administration
Number of participants with abnormal changes in clinical laboratory parameters
Measured: up to 90 days after first drug administration
Number of participants with adverse events
Measured: up to 90 days after first drug administration
Tolerability assessed by investigator on a 4-point scale
Measured: up to 90 days after first drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study startMar 2006
- Primary completionJul 2006
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
- None (open label)
- 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
- NCT02254174
- Sponsor's protocol ID
- 1184.11
- Status last verified
- Sep 2014
- First submitted
- 29 Sep 2014
- Last updated
- 1 Oct 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Open-label Four-way Crossover Study to Evaluate Relative Bioavailability of Tiotropium and Salmeterol After Inhalation of a Fixed Combined Single Dose (7.5 μg Tiotropium, 25 μg Salmeterol, Inhalation Powder, Hard Capsule, HandiHaler®2), a Free Combined Single Dose of 18 μg Tiotropium [Spiriva® HandiHaler®] and 50 μg Salmeterol [Serevent® Diskus®], a Single Dose of 50μg Salmeterol (Serevent® Diskus®) and a Single Dose of 18 μg Tiotropium (Spiriva® HandiHaler®) in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02254174
- Acronym / sponsor ID
- 1184.11
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Jul 2006 (actual)
- First posted
- 1 Oct 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.
Assessment of the relative bioavailability of a fixed dose combination of tiotropium and salmeterol compared to a free dose combination of the marketed products of tiotropium and salmeterol (Spiriva® and Serevent® Diskus®).
Assessment of the relative bioavailability of a fixed dose combination of tiotropium and salmeterol compared to tiotropium and salmeterol administered as individual mono substances from the marketed products.
Assessment of safety and tolerability of the fixed combination of tiotropium and salmeterol in a PE (Polyethylene) capsule administered via the HandiHaler® 2
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Tiotropium/Salmeterol | Experimental | Drug: Tiotropium/Salmeterol |
| Serevent® Diskus® | Active comparator | Drug: Serevent® Diskus® |
| Spiriva® | Active comparator | Drug: Spiriva® |
| Spiriva® and Serevent® Diskus® | Active comparator | Drug: Serevent® Diskus®, Drug: Spiriva® |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy male based upon a complete medical history, including the physical examination, regarding vital signs (blood pressure (BP), pulse rate (PR)), 12-lead ECG (electrocardiogram) measurement, and clinical laboratory tests. There is no finding deviating from normal and of clinical relevance.
- There is no evidence of a clinically relevant concomitant disease
- Age ≥21 and ≤50 years
- BMI ≥18.5 and <30 kg/m2 (Body Mass Index)
- Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation
Key exclusion criteria (26 listed)
- Any finding of the medical examination (including BP, PR, and ECG measurements) deviating from normal and of clinical relevance
- Evidence of a clinically relevant concomitant disease
- 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 relevant orthostatic hypotension, fainting spells or blackouts
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/SalmeterolFixed dose combination of tiotropium 7.5 μg and salmeterol 25 μg inhalation powder, PE capsule via HandiHaler® | Drug | Tiotropium/Salmeterol |
| Serevent® Diskus® | Drug | Serevent® Diskus®, Spiriva® and Serevent® Diskus® |
| Spiriva® | Drug | Spiriva®, Spiriva® and Serevent® Diskus® |
Primary outcome
AUC0-∞ (area under the concentration-time curve of salmeterol in blood plasma over the time interval from 0 extrapolated to infinity);
Time frame: Up to 8 hours after drug administration
Cmax (maximum measured concentration of salmeterol in blood plasma)
Time frame: Up to 8 hours after drug administration
Ae0-8 (urinary excretion of tiotropium over an 8 hour interval)
Time frame: Up to 8 hours after drug administration
19 secondary outcomes
AUC0-tz (area under the concentration-time curve in plasma over the time interval from 0 to the time of the last quantifiable data point)
Time frame: Up to 8 hours after drug administration
AUC0-∞ (area under the concentration-time curve of tiotropium in blood plasma over the time interval from 0 extrapolated to infinity)
Time frame: Up to 8 hours after drug administration
Cmax (maximum measured concentration of tiotropium in blood plasma)
Time frame: Up to 8 hours after drug administration
AUCt1-t2 (area under the concentration time curve in plasma over the time interval t1 to t2)
Time frame: up to 8 hours after inhalation
tmax (time from dosing to the maximum concentration of in plasma)
Time frame: Up to 8 hours after drug administration
λz (terminal rate constant in plasma)
Time frame: Up to 8 hours after drug administration
t½ (terminal half-life of in plasma)
Time frame: Up to 8 hours after drug administration
MRTih (mean residence time in the body after inhalational administration)
Time frame: Up to 8 hours after drug administration
CL/F (apparent clearance of in the plasma after extravascular administration)
Time frame: Up to 8 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: Up to 8 hours after drug administration
Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2
Time frame: up to 8 hours after inhalation
fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)
Time frame: up to 8 hours after inhalation
CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)
Time frame: up to 8 hours after inhalation
Number of participants with abnormal findings in physical examination
Time frame: up to 90 days after first drug administration
Number of participants with clinically significant changes in vital signs
Time frame: up to 90 days after first drug administration
Number of participants with abnormal findings in 12-lead ECG
Time frame: up to 90 days after first drug administration
Number of participants with abnormal changes in clinical laboratory parameters
Time frame: up to 90 days after first drug administration
Number of participants with adverse events
Time frame: up to 90 days after first drug administration
Tolerability assessed by investigator on a 4-point scale
Time frame: up to 90 days after first drug administration
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 1 Oct 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 Tiotropium/Salmeterol, Serevent® Diskus® and Spiriva® 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 5 inclusion and 26 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 1 Oct 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?
AUC0-∞ (area under the concentration-time curve of salmeterol in blood plasma over the time interval from 0 extrapolated to infinity); (time frame: Up to 8 hours after drug administration). 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 1 Oct 2014.