NCT01309139

Brief 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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2011

Completed
Same day until next milestone

Study Start

First participant enrolled

March 1, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 4, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Last Updated

November 1, 2013

Status Verified

October 1, 2013

Enrollment Period

3 months

First QC Date

March 1, 2011

Last Update Submit

October 31, 2013

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

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

    on several time points until day 22

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

    on several time points until day 22

  • AUCτ,ss for Tiotropium

    on several time points until day 22

  • Cmax,ss for Tiotropium

    on several time points until day 22

Secondary Outcomes (9)

  • AUCτ,ss for BI 54903

    on several time points until day 22

  • Cmax,ss for BI 54903

    on several time points until day 22

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

    on Day 1 and 21

  • Change in physical examination

    9 weeks

  • Change in vital signs

    9 weeks

  • +4 more secondary outcomes

Study Arms (4)

Treatment A: Tiotropium medium dose

EXPERIMENTAL

Oral inhalation daily for 21 days

Drug: Tiotropium

Treatment A: BI 54903 high dose

EXPERIMENTAL

Oral inhalation daily for 21 days

Drug: BI 54903

Treatment B: Tiotropium medium dose

EXPERIMENTAL

Oral inhalation daily for 21 days

Drug: Tiotropium

Treatment C: BI 54903 high dose

EXPERIMENTAL

Oral inhalation daily for 21 days

Drug: BI 54903

Interventions

TiotropiumDRUG

Medium dose of oral inhalation

Treatment A: Tiotropium medium dose
BI 54903DRUG

Medium dose of oral inhalation

Treatment C: BI 54903 high dose

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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 to 50 years.

You may not qualify if:

  • Any finding of the medical examination (including BP, PR and 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
  • History or evidence of relevant psychiatric disorders or neurological disorders
  • History or evidence of relevant autonomic dysfunction (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 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
  • Participation in another trial with an investigational drug within two months prior to administration or during the trial
  • Smoker (more than 10 cigarettes daily)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1298.2.1 Boehringer Ingelheim Investigational Site

Ingelheim, Germany

Location

MeSH Terms

Interventions

Tiotropium Bromide

Intervention Hierarchy (Ancestors)

Scopolamine DerivativesTropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2011

First Posted

March 4, 2011

Study Start

March 1, 2011

Primary Completion

June 1, 2011

Last Updated

November 1, 2013

Record last verified: 2013-10

Locations

DE(1)