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CompletedNCT02254174Updated Oct 1, 2014

Relative Bioavailability of Tiotropium and Salmeterol After Inhalation of a Fixed Combined Dose Compared to Monocomponents in Healthy Male Volunteers

A Phase 1 interventional study of Tiotropium/Salmeterol and Serevent® Diskus® in Healthy, sponsored by Boehringer Ingelheim. Completed. Open to male participants aged 21 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-01.

Sponsored by Boehringer Ingelheim · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
21 Years to 50 Years
Sex
Male
01

Study 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®).

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

02

Conditions studied

  • Healthy
03

In context

Respiratory Aspiration

1,092 studies on the registry are indexed under Respiratory Aspiration; 216 are open to participants now.

This study's enrollment of 36 is below the median of 42 across 881 interventional studies indexed under Respiratory Aspiration.

Browse Respiratory Aspiration studies →

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
21 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

  1. 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

  2. Age ≥21 and ≤50 years
  3. BMI ≥18.5 and \<30 kg/m2 (Body Mass Index)
  4. Signed and dated written informed consent prior to admission to the study in accordance with GCP (Good Clinical Practice) and the local legislation

Exclusion criteria

Exclusion Criteria:

  1. Any finding of the medical examination (including BP, PR, and ECG measurements) deviating from normal and of clinical relevance
  2. Evidence of a clinically relevant concomitant disease
  3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  4. Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
  5. History of relevant orthostatic hypotension, fainting spells or blackouts
  6. Chronic or relevant acute infections
  7. History of relevant allergy/hypersensitivity (including allergy to the drug or its excipients) as judged clinically relevant by the investigator
  8. 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
  9. 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
  10. Participation in another trial with an investigational drug within 2 months prior to randomisation
  11. Smoker (>10 cigarettes or >3 cigars or >3 pipes/day)
  12. Inability to refrain from smoking on trial days as judged by the investigator
  13. Alcohol abuse (more than 40 g alcohol a day)
  14. Drug abuse
  15. Blood donation (more than 100 mL blood within 4 weeks prior to randomisation or during the trial)
  16. Excessive physical activities within 1 week prior to randomisation or during the trial
  17. Any laboratory value outside the reference range that is of clinical relevance

  18. 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:

  19. Asthma or history of pulmonary hyperreactivity
  20. Hyperthyrosis
  21. Allergic rhinitis in need of treatment
  22. Clinically relevant cardiac arrhythmia

  23. 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:

  24. Hypersensitivity to tiotropium and/or related drugs of this class
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
36 participants (actual)

Study arms

  • Experimental
    Tiotropium/Salmeterol

    Drug: Tiotropium/Salmeterol

  • Active comparator
    Serevent® Diskus®

    Drug: Serevent® Diskus®

  • Active comparator
    Spiriva®

    Drug: Spiriva®

  • Active comparator
    Spiriva® and Serevent® Diskus®

    Drug: Serevent® Diskus® · Drug: Spiriva®

Interventions

  • DrugTiotropium/Salmeterol

    Fixed dose combination of tiotropium 7.5 μg and salmeterol 25 μg inhalation powder, PE capsule via HandiHaler®

  • DrugSerevent® Diskus®
  • DrugSpiriva®
06

What researchers measure

Primary outcomes

  1. 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

  2. Cmax (maximum measured concentration of salmeterol in blood plasma)

    Time frame: Up to 8 hours after drug administration

  3. Ae0-8 (urinary excretion of tiotropium over an 8 hour interval)

    Time frame: Up to 8 hours after drug administration

Secondary outcomes

  1. 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

  2. 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

  3. Cmax (maximum measured concentration of tiotropium in blood plasma)

    Time frame: Up to 8 hours after drug administration

  4. 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

  5. tmax (time from dosing to the maximum concentration of in plasma)

    Time frame: Up to 8 hours after drug administration

  6. λz (terminal rate constant in plasma)

    Time frame: Up to 8 hours after drug administration

  7. t½ (terminal half-life of in plasma)

    Time frame: Up to 8 hours after drug administration

  8. MRTih (mean residence time in the body after inhalational administration)

    Time frame: Up to 8 hours after drug administration

  9. CL/F (apparent clearance of in the plasma after extravascular administration)

    Time frame: Up to 8 hours after drug administration

  10. Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)

    Time frame: Up to 8 hours after drug administration

  11. 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

  12. fet1-t2 (fraction of analyte eliminated in urine from time point t1 to time point t2)

    Time frame: up to 8 hours after inhalation

  13. 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

  14. Number of participants with abnormal findings in physical examination

    Time frame: up to 90 days after first drug administration

  15. Number of participants with clinically significant changes in vital signs

    Time frame: up to 90 days after first drug administration

  16. Number of participants with abnormal findings in 12-lead ECG

    Time frame: up to 90 days after first drug administration

  17. Number of participants with abnormal changes in clinical laboratory parameters

    Time frame: up to 90 days after first drug administration

  18. Number of participants with adverse events

    Time frame: up to 90 days after first drug administration

  19. Tolerability assessed by investigator on a 4-point scale

    Time frame: up to 90 days after first drug administration

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 1, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02254174
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Oct 1, 2014
Start date
Mar 2006
Primary completion
Jul 2006
Last update
Oct 1, 2014
View the source record on ClinicalTrials.gov ↗

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