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CompletedNCT01309139Updated Nov 1, 2013

Pharmacokinetics of the Fixed Dose Combination of Tiotropium Plus BI 54903 Versus the Combination of the Monoproducts of Tiotropium and BI 54903 in Healthy Volunteers

A Phase 1 interventional study of Tiotropium and Tiotropium in Healthy, sponsored by Boehringer Ingelheim. Completed at 1 site in Germany. Open to participants aged 21 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-11-01.

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
All
01

Study summary

The primary objective is to compare the systemic exposure to tiotropium and CD 1857 after treatment with the fixed dose combination (fixed dose combination (FDC), Treatment A) of tiotropium plus BI 54903 (ethanolic solution for inhalation (EIS), Respimat (RMT) B) with the systemic exposure following inhalation of the free combination (Treatment B) of tiotropium (aqueous solution for inhalation (AIS), RMT A) plus BI 54903 (EIS, RMT B), when administered once-daily over 21 days via Respimat(R) (RMT).

The secondary objectives are:

to compare the systemic exposure to tiotropium and CD 1857 after single dose administration of FDC and of the free combination of tiotropium/BI 54903 to compare the systemic exposure to BI 54903 after a single dose and at steady state after multiple doses of the FDC and of the free combination of tiotropium/BI 54903 to compare the safety and tolerability of tiotropium and BI 54903 when administered as FDC and as free dose combination, respectively

02

Conditions studied

  • Healthy
03

In context

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
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy males and females 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 electrocardiogram (ECG), clinical laboratory tests.
  2. Age 21 to 50 years.

Exclusion criteria

Exclusion criteria:

  1. Any finding of the medical examination (including BP, PR and ECG) deviating from normal and of clinical relevance
  2. Any evidence of a clinically relevant concomitant disease
  3. Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  4. History or evidence of relevant psychiatric disorders or neurological disorders
  5. History or evidence of relevant autonomic dysfunction (orthostatic hypotension, fainting spells or blackouts)
  6. Chronic or relevant acute infections
  7. History of relevant allergy/hypersensitivity (including allergy to drug or its excipients)
  8. Intake of any prescription drugs or over-the-counter (over the counter (OTC)) medication (vitamins, herbal supplements, dietary supplements) with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial
  9. Participation in another trial with an investigational drug within two months prior to administration or during the trial
  10. Smoker (more than 10 cigarettes daily)
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
    Treatment A: Tiotropium medium dose

    Oral inhalation daily for 21 days

    Drug: Tiotropium

  • Experimental
    Treatment A: BI 54903 high dose

    Oral inhalation daily for 21 days

    Drug: BI 54903

  • Experimental
    Treatment B: Tiotropium medium dose

    Oral inhalation daily for 21 days

    Drug: Tiotropium

  • Experimental
    Treatment C: BI 54903 high dose

    Oral inhalation daily for 21 days

    Drug: BI 54903

Interventions

  • DrugTiotropium

    Medium dose of oral inhalation

  • DrugTiotropium

    Medium dose of oral inhalation

  • DrugBI 54903

    Medium dose of oral inhalation

  • DrugBI 54903

    Medium dose of oral inhalation

06

What researchers measure

Primary outcomes

  1. Area under the concentration time curve of CD 1857 in plasma over a uniform dosing interval τ (AUCτ,ss)

    Time frame: on several time points until day 22

  2. Maximum concentration of CD 1857 in plasma at steady state (Cmax,ss)

    Time frame: on several time points until day 22

  3. AUCτ,ss for Tiotropium

    Time frame: on several time points until day 22

  4. Cmax,ss for Tiotropium

    Time frame: on several time points until day 22

Secondary outcomes

  1. AUCτ,ss for BI 54903

    Time frame: on several time points until day 22

  2. Cmax,ss for BI 54903

    Time frame: on several time points until day 22

  3. Ae0-24 (Amount of analyte that is eliminated in urine) for tiotropium

    Time frame: on Day 1 and 21

  4. Change in physical examination

    Time frame: 9 weeks

  5. Change in vital signs

    Time frame: 9 weeks

  6. Change in 12-lead electrocardiogram

    Time frame: 9 weeks

  7. Change in clinical laboratory tests

    Time frame: 9 weeks

  8. Occurrence of Adverse Events

    Time frame: 9 weeks

  9. Assessment of tolerability by the investigator

    Time frame: 9 weeks

07

Study locations

1 site
  • 1298.2.1 Boehringer Ingelheim Investigational Site
    Ingelheim, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01309139
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Mar 4, 2011
Start date
Mar 2011
Primary completion
Jun 2011
Last update
Nov 1, 2013

Study contacts

Boehringer Ingelheim
study chair · Boehringer Ingelheim
View the source record on ClinicalTrials.gov ↗

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