ClinicalTrials.gg
Sign In
CompletedNCT02222428Updated Aug 21, 2014

Safety, Tolerability and Pharmacokinetics of the Fixed Dose Combination of BI 1744 CL Plus BI 54903 XX Via Respimat® B Versus the Mono Products of BI 1744 CL Via Respimat® A and BI 54903 XX Via Respimat® B in Healthy Male and Female Volunteers

A Phase 1 interventional study of BI 1744 CL/BI 54903 XX FDC and BI 54903 XX in Healthy, sponsored by Boehringer Ingelheim. Completed. Open to participants aged 21 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-08-21.

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 of this study was to compare the systemic exposure of BI 1744 BS and CD 1857 XX (the active metabolite of the pro-drug BI 54903 XX) at steady state following inhalation of the fixed dose combination (FDC) of 6.2 μg BI 1744 CL plus 727.3 μg BI 54903 XX (as ethanolic solution for inhalation, EIS) with the systemic exposure following inhalation of the mono compounds of 10 μg BI 1744 CL (as aqueous solution for inhalation, AIS) and 727.3 μg BI 54903 XX (EIS), respectively, when administered once-daily via Respimat® Inhaler (Respimat® A for AIS and Respimat® B for EIS) for 14 days in healthy volunteers. Secondary objectives were to compare exposure to BI 1744 BS and CD 1857 XX after a single dose of the BI 1744 CL/BI 54903 XX (6.2 μg/727.3 μg) FDC and the mono compounds, respectively; to compare exposure to BI 54903 XX after a single dose and at steady state after multiple doses of the BI 1744 CL/BI 54903 XX (6.2 μg/727.3 μg) FDC and the mono compounds, respectively; to compare the safety and tolerability of BI 1744 CL and BI 54903 XX when administered as BI 1744 CL/BI 54903 XX (6.2 μg/727.3 μg) FDC and as the mono compounds, respectively.

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,297 studies on the registry; 56 are open to participants now.

Of its 166 completed or terminated interventional studies of FDA-regulated products, 121 (73%) have results posted.

Browse Boehringer Ingelheim studies →

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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
  • Age >= 21 and Age \<= 50 years
  • Body mass index (BMI) >= 18.5 and \<= 29.9 kg/m2
  • Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

Exclusion criteria

Exclusion Criteria:

  • Any finding of the medical examination (including Blood pressure (BP), Pulse Rate (PR) and Electrocardiogram (ECG)) deviating from normal and of clinical relevance
  • Any evidence of a clinically relevant concomitant disease
  • Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
  • Surgery of the 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 relevant allergy/hypersensitivity (including allergy to drug or its excipients)
  • Intake of drugs with a long half-life (>24 h) 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 or that prolong the QT/QTc interval 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 (>10 cigarettes or >3 cigars or >3 pipes/day)
  • Inability to refrain from smoking on trial days
  • Alcohol abuse (more than 40 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 of clinical relevance
  • Inability to comply with dietary regimen of trial site

For female subjects:

  • Pregnancy or planning to become pregnant within 2 months of study completion
  • Positive pregnancy test
  • No adequate contraception e.g., sterilization, intrauterine device (IUD), oral contraception for at least 3 months prior to participation in the study
  • Inability to maintain this adequate contraception during the whole trial period
  • Lactation period
  • Asthma or history of pulmonary hyperreactivity
  • Hyperthyrosis
  • Allergic rhinitis in need of treatment
  • Clinically relevant cardiac arrhythmia
  • Bacterial and viral infections of the lung including tuberculosis
05

Study design

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

Study arms

  • Experimental
    BI 1744 CL/BI 54903 XX FDC

    Drug: BI 1744 CL/BI 54903 XX FDC

  • Active comparator
    BI 54903 XX

    Drug: BI 54903 XX

  • Active comparator
    BI 1744 CL

    Drug: BI 1744 CL

Interventions

06

What researchers measure

Primary outcomes

  1. AUC0-t,ss (area under the concentration time curve of the analyte in plasma from 0 to time t at steady state)

    for BI 1744 BS and CD 1857 XX

    Time frame: up to 24 hours after drug administration

  2. Cmax,ss (maximum measured concentration of the analyte in plasma at steady state)

    for BI 1744 BS and CD 1857 XX

    Time frame: up to 24 hours after drug administration

Secondary outcomes

  1. AUC0-t (area under the concentration time curve of the analyte in plasma from 0 to time t)

    Time frame: up to 24 hours after drug administration

  2. Cmax (maximum measured concentration of the analyte in plasma)

    for BI 54903 XX

    Time frame: up to 24 hours after drug administration

  3. Cpre (pre-dose concentration of the analyte in plasma (at steady state)

    Time frame: up to 24 hours after drug administration

  4. AUCt1-t2 (area under the concentration time curve of the analyte in plasma over the time interval t1 to t2)

    Time frame: up to 24 hours after drug administration

  5. 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 24 hours after drug administration

  6. AUCτ (area under the plasma concentration-time curve over a uniform dosing interval τ)

    Time frame: up to 24 hours after drug administration

  7. 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 24 hours after drug administration

  8. %AUCtz-∞ (the percentage of the AUC0-∞ that is obtained by extrapolation)

    Time frame: up to 24 hours after drug administration

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

    Time frame: up to 24 hours after drug administration

  10. λz (terminal rate constant of the analyte in plasma)

    Time frame: up to 24 hours after drug administration

  11. t½ (terminal half-life of the analyte in plasma)

    Time frame: up to 24 hours after drug administration

  12. MRTih (mean residence time of the analyte in the body after inhaled administration)

    Time frame: up to 24 hours after drug administration

  13. Aet1-t2 (amount of the analyte that is eliminated in urine from the time point t1 to time point t2)

    Time frame: up to 24 hours after drug administration

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

    Time frame: up to 24 hours after drug administration

  15. CLR,t1-t2 (renal clearance of the analyte from the time point t1 until the time point t2)

    Time frame: up to 24 hours after drug administration

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

    For BI 1744 BS and BI 54903 XX only

    Time frame: up to 24 hours after drug administration

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

    For BI 1744 BS and BI 54903 XX only

    Time frame: up to 24 hours after drug administration

  18. Number of patients with adverse events

    Time frame: up to 16 weeks

  19. Assessment of tolerability by investigator on 4-point scale

    Time frame: 28 days after each treatment period

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2009 and a primary completion of Jul 2009. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 19, 2014
First posted
Aug 21, 2014
Start
Apr 2009
Primary completionActual
Jul 2009
Last update
Aug 21, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 21, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02222428
Lead sponsor
Boehringer Ingelheim
Responsible party
Sponsor
First posted
Aug 21, 2014
Start date
Apr 2009
Primary completion
Jul 2009
Last update
Aug 21, 2014
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

Boehringer Ingelheim →

Start the discussion