A Double-blind, Randomised Study to Assess the Influence of Tiotropium (Spiriva®)

NCT00257452 | Completed Phase 1

• 1 other identifier: 205.302
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

To demonstrate that tiotropium (Spiriva®) does not prolong the QT interval of the ECG more than placebo

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Mean change from baseline of the corresponding QTcF values of all ECGs taken from 5 minutes to 2 hours after dosing

  Day 12

Secondary Outcomes (3)

• Mean change from baseline of the corresponding QTcF values of all ECGs taken from 5 minutes to 2 hours after dosing

  Day 1

• Mean change from baseline of the corresponding QTcF values of all ECGs taken from 5 minutes to 24 hours after dosing

  Day 1 and 12

• Difference (tiotropium minus placebo) between the maximal time-matched change from baseline of the QTcF values of all ECGs taken from 0:05 - 23:50 after dosing

  Day 1 and 12

Interventions

tiotropium 18 mcg or 54 mcg qd DRUG

placebo matching tiotropium qd DRUG

moxifloxacin 200 mg DRUG

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
• Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
• Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
• History of 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
• Intake of drugs with a long half-life (\> 24:00 hours) within at least one month or less than ten half-lives of the respective drug before enrolment in the study or during the study
• Use of any drugs which might influence the results of the trial up to 7 days prior to enrolment in the study or during the study
• Participation in another trial with an investigational drug ( two months prior to administration or during the trial)
• Smoker (\> 10 cigarettes or \> 3 cigars of \> 3 pipes/day)
• Inability to refrain from smoking on trial days
• Alcohol abuse (\> 60 g/day)
• Drug abuse
• Blood donation (\> 100 mL within four weeks prior to administration or during the trial)
• Any laboratory value outside the reference range if indicative of underlying disease or poor health

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Humanpharmakologisches Zentrum

Ingelheim/Rhein, 55216, Germany

Location

MeSH Terms

Interventions

Tiotropium Bromide; Moxifloxacin

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Boehringer Ingelheim Study Coordinator

  B.I. Pharma GmbH & Co. KG

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 21, 2005
• First Posted: November 23, 2005
• Study Start: October 1, 2004
• Primary Completion: July 1, 2005
• Study Completion: July 1, 2005
• Last Updated: November 1, 2013

Record last verified: 2013-10

Locations

DE (1)