HealthyPhase 1NCT02254226
Pharmacokinetics of Salmeterol (Serevent®) After Inhalation With Metered Dose Inhaler (MDI) and Diskus® in Healthy Male Volunteers
A Phase 1 study testing Salmeterol Diskus low, Salmeterol Diskus high and Salmeterol MDI low in people with Healthy, run by Boehringer Ingelheim.
Trial summary
1. To compare the systemic drug exposure of 100 μg Serevent ® Diskus ® with that of 50 μg Serevent ® MDI with sufficient precision so that in combination with a second trial it can be demonstrated that the systemic drug exposure of a new formulation of salmeterol xinafoate is not superior to that of Serevent ® MDI 2. 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?
- Salmeterol Diskus low, Salmeterol Diskus high and Salmeterol MDI low
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- Nov 2004to Jan 2005
- 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 according to the following criteria:
- Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead ECG (electrocardiogram) , clinical laboratory tests 1.1 No finding deviating from normal and of clinical relevance 1.2 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 Good Clinical Practice (GCP) and the local legislation.
Who cannot join
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of gastrointestinal tract (except appendectomy)
- 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
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
Show all 24Show fewer
- 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 administration or during the trial.
- 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 administration or during the trial.
- Participation in another trial with an investigational drug within 2 months prior to administration or during the trial.
- Smoker (more than 10 cigarettes or three cigars or three pipes per day)
- Inability to refrain from smoking on trial days
- Alcohol abuse (more than 60 g/day)
- Drug abuse
- Blood donation (more than 100 mL within 4 weeks prior to administration or during the trial)
- Excessive physical activities (within 1 week prior to administration or during the trial)
- Any laboratory value outside the reference range that is of clinical relevance
- Inability to comply with dietary regimen of study centre
- Asthma or history of pulmonary hyperreactivity
- Allergy / hypersensitivity to Lactose monohydrate
- Hyperthyrosis
- Allergic rhinitis in need of treatment
- Cardiac arrhythmia
- Paroxysmal tachycardia (> 100 beats per minute)
- Aortic stenosis
About this study
Official title: A Randomised, Open-label Four-way Crossover Study to Evaluate Pharmacokinetics of Salmeterol (Serevent®) After Inhalation of a 25 μg and 50 μg Single Dose (Metered Dose Inhaler) and a 50 μg and 100 μg Single Dose (Diskus®) in Healthy Male Volunteers
- To compare the systemic drug exposure of 100 μg Serevent ® Diskus ® with that of 50 μg Serevent ® MDI with sufficient precision so that in combination with a second trial it can be demonstrated that the systemic drug exposure of a new formulation of salmeterol xinafoate is not superior to that of Serevent ® MDI
- To test a system of ordered null hypotheses regarding the exposure of two dose levels of Serevent ® Diskus ® and Serevent ® MDI
- To get data about the systemic drug exposure of 25 μg Serevent ® MDI and of 50 μg Serevent ® Diskus ®
- Conditions
- Healthy
- Being tested
- Salmeterol Diskus low, Salmeterol Diskus high, Salmeterol MDI low, Salmeterol MDI high
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salmeterol Diskus lowDrug
Salmeterol Diskus highDrug
Salmeterol MDI lowDrug
Salmeterol MDI highDrug
| Study group | Role | What they receive |
|---|---|---|
| Salmeterol MDI low | Experimental | Not described Receives: Drug: Salmeterol MDI low |
| Salmeterol MDI high | Active comparator | Not described Receives: Drug: Salmeterol MDI high |
| Salmeterol Diskus low | Experimental | Not described Receives: Drug: Salmeterol Diskus low |
| Salmeterol Diskus high | Experimental | Not described Receives: Drug: Salmeterol Diskus high |
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 the analyte in plasma over the time interval from 0 extrapolated to infinity)
Measured: Up to 6 hours after drug administration
Cmax (maximum measured concentration of the analyte in plasma)
Measured: Up to 6 hours after drug administration
Secondary outcomes (16)
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
Measured: Up to 6 hours after drug administration
AUCt1-t2 (Area under the concentration time curve of the analyte in plasma over the time interval t1 to t2)
Measured: Up to 6 hours after inhalation
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Measured: Up to 6 hours after drug administration
λz (terminal rate constant in plasma)
Measured: Up to 6 hours after drug administration
t½ (terminal half-life of the analyte in plasma)
Measured: Up to 6 hours after drug administration
MRTinh (mean residence time of the analyte in the body after inhalational administration)
Measured: Up to 6 hours after drug administration
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Measured: Up to 6 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Measured: Up to 6 hours after drug administration
Aet1-t2 (amount of analyte that was eliminated in urine from the time interval t1 to t2)
Measured: Up to 6 hours after inhalation
fet1-t2 (fraction of administered drug excreted unchanged in urine from time point t1 to t2)
Measured: Up to 6 hours after inhalation
CLR,t1-t2 (renal clearance of the analyte in plasma from the time point t1 to t2)
Measured: Up to 6 hours after inhalation
Number of participants with abnormal findings in physical examination
Measured: Up to 15 days after last drug administration
Number of participants with clinically significant changes in vital signs
Measured: Up to 15 days after last drug administration
Number of participants with abnormal findings in ECG
Measured: Up to 15 days after last drug administration
Number of participants with abnormal changes in clinical laboratory parameters
Measured: Up to 15 days after last drug administration
Number of participants with adverse events
Measured: Up to 15 days after last 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 startNov 2004
- Primary completionJan 2005
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
- 26 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
- NCT02254226
- Sponsor's protocol ID
- 1184.8
- 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 Pharmacokinetics of Salmeterol (Serevent®) After Inhalation of a 25 μg and 50 μg Single Dose (Metered Dose Inhaler) and a 50 μg and 100 μg Single Dose (Diskus®) in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02254226
- Acronym / sponsor ID
- 1184.8
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Primary completion
- Jan 2005 (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.
- To compare the systemic drug exposure of 100 μg Serevent ® Diskus ® with that of 50 μg Serevent ® MDI with sufficient precision so that in combination with a second trial it can be demonstrated that the systemic drug exposure of a new formulation of salmeterol xinafoate is not superior to that of Serevent ® MDI
- To test a system of ordered null hypotheses regarding the exposure of two dose levels of Serevent ® Diskus ® and Serevent ® MDI
- To get data about the systemic drug exposure of 25 μg Serevent ® MDI and of 50 μg Serevent ® Diskus ®
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Salmeterol MDI low | Experimental | Drug: Salmeterol MDI low |
| Salmeterol MDI high | Active comparator | Drug: Salmeterol MDI high |
| Salmeterol Diskus low | Experimental | Drug: Salmeterol Diskus low |
| Salmeterol Diskus high | Experimental | Drug: Salmeterol Diskus high |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy males according to the following criteria:
- Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead ECG (electrocardiogram) , clinical laboratory tests 1.1 No finding deviating from normal and of clinical relevance 1.2 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 Good Clinical Practice (GCP) and the local legislation.
Key exclusion criteria (24 listed)
- Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
- Surgery of gastrointestinal tract (except appendectomy)
- 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
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 |
|---|---|---|
| Salmeterol Diskus low | Drug | Salmeterol Diskus low |
| Salmeterol Diskus high | Drug | Salmeterol Diskus high |
| Salmeterol MDI low | Drug | Salmeterol MDI low |
| Salmeterol MDI high | Drug | Salmeterol MDI high |
Primary outcome
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: Up to 6 hours after drug administration
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: Up to 6 hours after drug administration
16 secondary outcomes
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
Time frame: Up to 6 hours after drug administration
AUCt1-t2 (Area under the concentration time curve of the analyte in plasma over the time interval t1 to t2)
Time frame: Up to 6 hours after inhalation
tmax (time from dosing to the maximum concentration of the analyte in plasma)
Time frame: Up to 6 hours after drug administration
λz (terminal rate constant in plasma)
Time frame: Up to 6 hours after drug administration
t½ (terminal half-life of the analyte in plasma)
Time frame: Up to 6 hours after drug administration
MRTinh (mean residence time of the analyte in the body after inhalational administration)
Time frame: Up to 6 hours after drug administration
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Time frame: Up to 6 hours after drug administration
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: Up to 6 hours after drug administration
Aet1-t2 (amount of analyte that was eliminated in urine from the time interval t1 to t2)
Time frame: Up to 6 hours after inhalation
fet1-t2 (fraction of administered drug excreted unchanged in urine from time point t1 to t2)
Time frame: Up to 6 hours after inhalation
CLR,t1-t2 (renal clearance of the analyte in plasma from the time point t1 to t2)
Time frame: Up to 6 hours after inhalation
Number of participants with abnormal findings in physical examination
Time frame: Up to 15 days after last drug administration
Number of participants with clinically significant changes in vital signs
Time frame: Up to 15 days after last drug administration
Number of participants with abnormal findings in ECG
Time frame: Up to 15 days after last drug administration
Number of participants with abnormal changes in clinical laboratory parameters
Time frame: Up to 15 days after last drug administration
Number of participants with adverse events
Time frame: Up to 15 days after last 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 Salmeterol Diskus low, Salmeterol Diskus high and Salmeterol MDI low 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 24 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 the analyte in plasma over the time interval from 0 extrapolated to infinity) (time frame: Up to 6 hours after drug administration). The study lists 2 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.