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HealthyPhase 1NCT00257452

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

A Phase 1 study testing tiotropium 18 mcg or 54 mcg qd and moxifloxacin 200 mg in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 21 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
tiotropium 18 mcg or 54 mcg qd and moxifloxacin 200 mg
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
56 participants
Where
1 siteGermany
Study dates
Oct 2004to Jul 2005
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

None listed.

Who cannot join

  • 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
Show all 24Show fewer
  • 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
  • Excessive physical activities within the last week before the trial or during the trial
  • Hypersensitivity to tiotropium, moxifloxacin and/or related drugs of these classes
  • Heart rate at screening of > 80 bpm or < 45 bpm
  • Any screening ECG value outside of the reference range of clinical relevance including, but not limited to PR interval > 220 ms, QRS interval > 115 ms, QTcB or QTcF > 450 ms, or QT (uncorrected) > 470 ms
  • For Female Subjects:
  • Pregnancy
  • Positive pregnancy test
  • No adequate contraception (adequate contraception e.g. sterilisation, IUP, oral contraceptives)
  • Inability to maintain this adequate contraception during the whole study period Lactation period.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Humanpharmakologisches Zentrum

    Ingelheim/Rhein, 55216

Other trials in Germany

About this study

Official title: A Double-blind, Randomised, Placebo Controlled, Three-way Cross-over Study With an Open Label Positive Control (Moxifloxacin) to Assess the Influence of Inhaled Tiotropium Once Daily Over Twelve Days on the QTC Interval of the ECG in Healthy Male and Female Volunteers

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

Read the detailed description

The objective of this study is to demonstrate that tiotropium does not prolong the QT interval more than placebo. This will be achieved by testing non-inferiority hypothesis.

Study Hypothesis:

There is one primary variable to be tested for non-inferiority: tiotropium high dose compared to placebo:

H0: µ(TIO,12) - µ(PBO,12) >= 10 ms vs. H1: µ(TIO,12) - µ(PBO,12) < 10 ms where µ(TIO,12), µ(PBO,12) represent the mean change from baseline QTcF between 5 minutes and 2 hours after 12 days of treatment (taking the mean of the time-matched differences between baseline and post-baseline values in each treatment period) with tiotropium 54 µg, or placebo, respectively.

If the data suggest that the Fridericia correction is poor for the study population, an alternative correction will be explored (QTcN). The other correction formula would be used as a replacement for the Fridericia correction and would be defined before unblinding of the data.

Comparison(s):

Placebo, moxifloxacin as active control

Conditions
Healthy
Being tested
tiotropium 18 mcg or 54 mcg qd, placebo matching tiotropium qd, moxifloxacin 200 mg

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tiotropium 18 mcg or 54 mcg qdDrug

  • placebo matching tiotropium qdDrug

  • moxifloxacin 200 mgDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Day 12

Secondary outcomes (3)

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

    Measured: Day 1

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

    Measured: Day 1 and 12

  3. 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

    Measured: Day 1 and 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2005 (estimated)
  2. Study startOct 2004
  3. Primary completionJul 2005
  4. Study completionJul 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Enrolment
56 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00257452
Sponsor's protocol ID
205.302
Status last verified
Oct 2013
First submitted
21 Nov 2005
Last updated
1 Nov 2013
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing tiotropium 18 mcg or 54 mcg qd and moxifloxacin 200 mg in people with Healthy, run by Boehringer Ingelheim at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change from baseline of the corresponding QTcF values of all ECGs taken from 5 minutes to 2 hours after dosing (time frame: Day 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00257452.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2013.

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Clinical Trial NCT00257452 | AzTrials