Cystic FibrosisPhase 1NCT02172534
Safety, Tolerability and Pharmacokinetics of Tiotropium in Cystic Fibrosis Patients
A Phase 1 study testing Tiotropium bromide low, Tiotropium bromide medium and Tiotropium bromide high in people with Cystic Fibrosis, run by Boehringer Ingelheim.
Trial summary
Study to obtain information about the safety and tolerability of tiotropium bromide administered via the Respimat® inhalation device in pediatric (≤11 y.o.) and adolescent/adult (≥12 y.o.) cystic fibrosis (CF) patients after single and multiple doses as well as to obtain pharmacokinetic data for tiotropium in CF… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Tiotropium bromide low, Tiotropium bromide medium and Tiotropium bromide high
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 113 participants
- Where
- No sites listed yet
- Study dates
- Sep 2006to Sep 2008
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female patients (pediatric ≤11 years; adolescent / adult ≥12 years)
- Documented diagnosis of CF (positive sweat chloride ≥60 mEq/liter, by pilocarpine iontophoresis) and/or a genotype with two identifiable mutations consistent with CF accompanied by one or more clinical features with the CF phenotype
- Able to perform acceptable spirometric maneuvers, according to ATS (American Thoracic Society) standards
- FEV1 >25% of predicted values
- Patients must be able to inhale medication in a reproducible manner from the Respimat® inhaler and from a metered dose inhaler (MDI)
- Clinical stability:
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- no evidence of acute upper or lower respiratory tract infection within 4 weeks of screening
- no pulmonary exacerbation requiring use of i.v./oral/inhaled antibiotics, or oral corticosteroids within 4 weeks of screening
- FEV1 at Visit 2 must be within 10% of FEV1 at Visit 1. If FEV1 at Visit 2 is not within 10% of FEV1 at Visit 1, Visit 2 may be re-scheduled once within 7 days
- The patient or the patient's legally acceptable representative must be able to give informed consent in accordance with International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines and local regulation
- Patients taking a chronic medication must be willing to continue this therapy for the entire duration of the study
Who cannot join
- Patients with a significant history of allergy / hypersensitivity (including medication allergy) which is deemed relevant to the trial as judged by the Investigator. "Relevance" in this context refers to any increased risk of hypersensitivity reaction to trial medication
- Patients with a known hypersensitivity to study drug or its components
- Patients who have participated in another study with an Investigational drug within one month or six half-lives (whichever is greater) preceding the screening visit
- Patients who are currently participating in another trial. Observational studies are allowed. Permission should be obtained from the sponsor of the study
- Patients with known relevant substance abuse, including alcohol or drug abuse. The intention of this criterion was to exclude patients who are considered to be at risk of not complying with or abusing the trial medication administration directives.
- Female patients who are pregnant or lactating, including females who have a positive urine pregnancy test at screening (pregnancy tests were performed for all females of child bearing potential)
Show all 10Show fewer
- Female patients of child bearing potential who are not using a medically approved form of contraception.
- Patients with documented persistent colonization with B. cepacia (defined as more than one positive culture within the past year). The intention of this exclusion criterion is to be consistent with the current policy within the CF community for reducing the risk of B. cepacia cross infection.
- Patients who have started a new chronic medication for CF within four (4) weeks of screening. Patients who are on a cycling TOBI® (Tobramycin treatment) regimen must have completed at least three (3) cycles of every other month TOBI® administration prior to the screening visit. As there are other cycles used with TOBI®, the clinical monitor should be consulted before the patient was enrolled.
- Clinically significant disease or medical condition other than CF or CF-related conditions that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data. This included significant hematological, hepatic, renal, cardiovascular, and neurologic disease. Patients with diabetes could participate if their disease is under good control prior to screening. This criterion provides an opportunity for the investigator to exclude patients based on clinical judgment, even if other eligibility criteria are satisfied.
About this study
Official title: A Randomized, Double-blind Within Dose, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Increasing Single and Multiple Doses (28-day Dosing) of Tiotropium Bromide Administered Once Daily Via the Respimat® Device in Cystic Fibrosis Patients
Study to obtain information about the safety and tolerability of tiotropium bromide administered via the Respimat® inhalation device in pediatric (≤11 y.o.) and adolescent/adult (≥12 y.o.) cystic fibrosis (CF) patients after single and multiple doses as well as to obtain pharmacokinetic data for tiotropium in CF patients after single and multiple doses
- Conditions
- Cystic Fibrosis
- Being tested
- Tiotropium bromide low, Tiotropium bromide medium, Tiotropium bromide high, Placebo
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tiotropium bromide lowDrug
Tiotropium bromide mediumDrug
Tiotropium bromide highDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Tiotropium bromide low | Experimental | Single dose: 2.5 µg Tiotropium Receives: Drug: Tiotropium bromide low |
| Tiotropium bromide medium | Experimental | Single dose: 5 µg Tiotropium Receives: Drug: Tiotropium bromide medium |
| Tiotropium bromide high | Experimental | Single dose: 10 µg Tiotropium Receives: Drug: Tiotropium bromide high |
| Tiotropium bromide low (28 days) | Experimental | multiple dose: 2.5 µg Tiotropium Receives: Drug: Tiotropium bromide low |
| Tiotropium bromide medium (28 days) | Experimental | Multiple dose: 5 µg Tiotropium Receives: Drug: Tiotropium bromide medium |
| Placebo | Placebo comparator | single or multiple dose of Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in physical examination
Measured: Baseline, Day 1 and 28
Changes from baseline in blood pressure
Measured: Baseline, Day 1 and 28
Changes from baseline in pulse rate
Measured: Baseline, Day 1 and 28
Changes from baseline in laboratory evaluation
Measured: Baseline, Day 28
Occurrence of Adverse Events
Measured: up to 59 days
Change in FEV1 (Forced expiratory volume in one second)
Measured: Pre-dose and 0.5, 1 and 2 hours after treatment on Day1 and 28
Change in FVC (Forced vital capacity)
Measured: Pre-dose and 0.5, 1 and 2 hours after treatment on Day1 and 28
Change in FEF25-75% (Forced Expiratory Flow)
Measured: Pre-dose and 0.5, 1 and 2 hours after treatment on Day1 and 28
Secondary outcomes (30)
Cmax (maximum concentration of the analyte in plasma) after the first dose of 2.5 μg tiotropium bromide
Measured: Pre-dose and 5, 15, 30 min and 1, 2, 4, 6 hours after treatment on Day1
tmax (time from dosing to maximum concentration) after the first dose of 2.5 μg tiotropium bromide
Measured: Pre-dose and 5, 15, 30 min and 1, 2, 4, 6 hours after treatment on Day1
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point within the first dosing of 2.5 μg tiotropium bromide interval)
Measured: Pre-dose and 5, 15, 30 min and 1, 2, 4, 6 hours after treatment on Day1
Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2) after the first dose of 2.5 μg tiotropium bromide
Measured: Pre-dose and 0-2, 2-4 and 4-8 hours after treatment on Day1
fet1-t2 (fraction of analyte excreted in urine from time point t1 to t2) after the first dose of 2.5 μg tiotropium bromide
Measured: Pre-dose and 0-2, 2-4 and 4-8 hours after treatment on Day1
AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time interval t1 to t2) after the first dose of 5 μg and 10 μg tiotropium bromide
Measured: Pre-dose and 5, 15, 30 min and 1, 2, 4, 6 hours after treatment on Day1
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) after the first dose of 5 μg and 10 μg tiotropium bromide
Measured: Pre-dose and 5, 15, 30 min and 1, 2, 4, 6 hours after treatment on Day1
%AUCtz-∞ (the percentage of the AUC 0-∞ that is obtained by extrapolation) after the first dose of 5 μg and 10 μg tiotropium bromide
Measured: Pre-dose and 5, 15, 30 min and 1, 2, 4, 6 hours after treatment on Day1
λz (terminal rate constant of the analyte in plasma) after the first dose of 5 μg and 10 μg tiotropium bromide
Measured: Pre-dose and 5, 15, 30 min and 1, 2, 4, 6 hours after treatment on Day1
t½ (terminal half-life of the analyte in plasma) after the first dose of 5 μg and 10 μg tiotropium bromide
Measured: Pre-dose and 5, 15, 30 min and 1, 2, 4, 6 hours after treatment on Day1
MRTih (mean residence time of the analyte in the body after inhalation) after the first dose of 5 μg and 10 μg tiotropium bromide
Measured: Pre-dose and 5, 15, 30 min and 1, 2, 4, 6 hours after treatment on Day1
CL/F (apparent clearance of the analyte in the plasma after extravascular administration) after the first dose of 5 μg and 10 μg tiotropium bromide
Measured: Pre-dose and 5, 15, 30 min and 1, 2, 4, 6 hours after treatment on Day1
Vz/F (apparent volume of distribution of the analyte during the terminal phase λz following an extravascular dose) after the first dose of 5 μg and 10 μg tiotropium bromide
Measured: Pre-dose and 5, 15, 30 min and 1, 2, 4, 6 hours after treatment on Day1
CLR,t1- t2 (renal clearance of the analyte in plasma from the time point t1 to time point t2) after the first dose of 5 μg and 10 μg tiotropium bromide
Measured: Pre-dose and 5, 15, 30 min and 1, 2, 4, 6 hours after treatment on Day1
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Measured: Pre-dose and 5, 15, 30 min and 1, 2, 4, 6 hours after treatment on Day 28
tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state)
Measured: Pre-dose and 5, 15, 30 min and 1, 2, 4, 6 hours after treatment on Day 28
Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Measured: Pre-dose and 5, 15, 30 min and 1, 2, 4, 6 hours after treatment on Day 28
Cpre,ss(predose concentration of the analyte in plasma at steady state immediately before administration of the next dose)
Measured: Pre-dose and 5, 15, 30 min and 1, 2, 4, 6 hours after treatment on Day 28
AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)
Measured: Pre-dose and 5, 15, 30 min and 1, 2, 4, 6 hours after treatment on Day 28
λz,ss (terminal rate constant in plasma at steady state)
Measured: Pre-dose and 5, 15, 30 min and 1, 2, 4, 6 hours after treatment on Day 28
t1/2,ss (terminal half-life of the analyte in plasma at steady state)
Measured: Pre-dose and 5, 15, 30 min and 1, 2, 4, 6 hours after treatment on Day 28
MRTih,ss (mean residence time of the analyte in the body after 14 administrations at steady state)
Measured: Pre-dose and 5, 15, 30 min and 1, 2, 4, 6 hours after treatment on Day 28
CL/F,ss (apparent clearance of the analyte in the plasma at steady state following extravascular multiple dose administration)
Measured: Pre-dose and 5, 15, 30 min and 1, 2, 4, 6 hours after treatment on Day 28
Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration)
Measured: Pre-dose and 5, 15, 30 min and 1, 2, 4, 6 hours after treatment on Day 28
Aet1-t2,ss (amount of analyte that is eliminated in urine at steady state from the time point t1 to time point t2)
Measured: Pre-dose and 0-2, 2-4 and 4-8 hours after treatment on Day 28
fet1-t2,ss (fraction of analyte eliminated in urine at steady state from time point t1 to time point t2)
Measured: Pre-dose and 0-2, 2-4 and 4-8 hours after treatment on Day 28
CLR,t1-t2,ss (renal clearance of the analyte in plasma from the time point t1 until the time point t2 at steady state)
Measured: Pre-dose and 5, 15, 30 min and 1, 2, 4, 6 hours after treatment on Day 28
Accumulation Ratio (R)A,Cmax,28 based on Cmax
Measured: 28 days
Accumulation Ratio (R)A,AUC,28 based on AUC0-τ
Measured: 28 days
Linearity index (LI)
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study startSep 2006
- Primary completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Parallel groups
- Masking
- Double blind
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02172534
- Sponsor's protocol ID
- 205.338
- Status last verified
- Jun 2014
- First submitted
- 20 Jun 2014
- Last updated
- 24 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Within Dose, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Increasing Single and Multiple Doses (28-day Dosing) of Tiotropium Bromide Administered Once Daily Via the Respimat® Device in Cystic Fibrosis Patients
- ClinicalTrials.gov ID
- NCT02172534
- Acronym / sponsor ID
- 205.338
- Conditions
- Cystic Fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Primary completion
- Sep 2008 (actual)
- First posted
- 24 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to obtain information about the safety and tolerability of tiotropium bromide administered via the Respimat® inhalation device in pediatric (≤11 y.o.) and adolescent/adult (≥12 y.o.) cystic fibrosis (CF) patients after single and multiple doses as well as to obtain pharmacokinetic data for tiotropium in CF patients after single and multiple doses
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Tiotropium bromide low | Experimental | Drug: Tiotropium bromide lowSingle dose: 2.5 µg Tiotropium |
| Tiotropium bromide medium | Experimental | Drug: Tiotropium bromide mediumSingle dose: 5 µg Tiotropium |
| Tiotropium bromide high | Experimental | Drug: Tiotropium bromide highSingle dose: 10 µg Tiotropium |
| Tiotropium bromide low (28 days) | Experimental | Drug: Tiotropium bromide lowmultiple dose: 2.5 µg Tiotropium |
| Tiotropium bromide medium (28 days) | Experimental | Drug: Tiotropium bromide mediumMultiple dose: 5 µg Tiotropium |
| Placebo | Placebo comparator | Drug: Placebosingle or multiple dose of Placebo |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female patients (pediatric ≤11 years; adolescent / adult ≥12 years)
- Documented diagnosis of CF (positive sweat chloride ≥60 mEq/liter, by pilocarpine iontophoresis) and/or a genotype with two identifiable mutations consistent with CF accompanied by one or more clinical features with the CF phenotype
- Able to perform acceptable spirometric maneuvers, according to ATS (American Thoracic Society) standards
- FEV1 >25% of predicted values
- Patients must be able to inhale medication in a reproducible manner from the Respimat® inhaler and from a metered dose inhaler (MDI)
Key exclusion criteria (10 listed)
- Patients with a significant history of allergy / hypersensitivity (including medication allergy) which is deemed relevant to the trial as judged by the Investigator. "Relevance" in this context refers to any increased risk of hypersensitivity reaction to trial medication
- Patients with a known hypersensitivity to study drug or its components
- Patients who have participated in another study with an Investigational drug within one month or six half-lives (whichever is greater) preceding the screening visit
- Patients who are currently participating in another trial. Observational studies are allowed. Permission should be obtained from the sponsor of the study
- Patients with known relevant substance abuse, including alcohol or drug abuse. The intention of this criterion was to exclude patients who are considered to be at risk of not complying with or abusing the trial medication administration directives.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tiotropium bromide low | Drug | Tiotropium bromide low, Tiotropium bromide low (28 days) |
| Tiotropium bromide medium | Drug | Tiotropium bromide medium, Tiotropium bromide medium (28 days) |
| Tiotropium bromide high | Drug | Tiotropium bromide high |
| Placebo | Drug | Placebo |
Primary outcome
Changes from baseline in physical examination
Time frame: Baseline, Day 1 and 28
Changes from baseline in blood pressure
Time frame: Baseline, Day 1 and 28
Changes from baseline in pulse rate
Time frame: Baseline, Day 1 and 28
Changes from baseline in laboratory evaluation
Time frame: Baseline, Day 28
Occurrence of Adverse Events
Time frame: up to 59 days
Change in FEV1 (Forced expiratory volume in one second)
Time frame: Pre-dose and 0.5, 1 and 2 hours after treatment on Day1 and 28
Change in FVC (Forced vital capacity)
Time frame: Pre-dose and 0.5, 1 and 2 hours after treatment on Day1 and 28
Change in FEF25-75% (Forced Expiratory Flow)
Time frame: Pre-dose and 0.5, 1 and 2 hours after treatment on Day1 and 28
30 secondary outcomes
Cmax (maximum concentration of the analyte in plasma) after the first dose of 2.5 μg tiotropium bromide
Time frame: Pre-dose and 5, 15, 30 min and 1, 2, 4, 6 hours after treatment on Day1
tmax (time from dosing to maximum concentration) after the first dose of 2.5 μg tiotropium bromide
Time frame: Pre-dose and 5, 15, 30 min and 1, 2, 4, 6 hours after treatment on Day1
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point within the first dosing of 2.5 μg tiotropium bromide interval)
Time frame: Pre-dose and 5, 15, 30 min and 1, 2, 4, 6 hours after treatment on Day1
Aet1-t2 (amount of analyte that is eliminated in urine from the time point t1 to time point t2) after the first dose of 2.5 μg tiotropium bromide
Time frame: Pre-dose and 0-2, 2-4 and 4-8 hours after treatment on Day1
fet1-t2 (fraction of analyte excreted in urine from time point t1 to t2) after the first dose of 2.5 μg tiotropium bromide
Time frame: Pre-dose and 0-2, 2-4 and 4-8 hours after treatment on Day1
AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time interval t1 to t2) after the first dose of 5 μg and 10 μg tiotropium bromide
Time frame: Pre-dose and 5, 15, 30 min and 1, 2, 4, 6 hours after treatment on Day1
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) after the first dose of 5 μg and 10 μg tiotropium bromide
Time frame: Pre-dose and 5, 15, 30 min and 1, 2, 4, 6 hours after treatment on Day1
%AUCtz-∞ (the percentage of the AUC 0-∞ that is obtained by extrapolation) after the first dose of 5 μg and 10 μg tiotropium bromide
Time frame: Pre-dose and 5, 15, 30 min and 1, 2, 4, 6 hours after treatment on Day1
λz (terminal rate constant of the analyte in plasma) after the first dose of 5 μg and 10 μg tiotropium bromide
Time frame: Pre-dose and 5, 15, 30 min and 1, 2, 4, 6 hours after treatment on Day1
t½ (terminal half-life of the analyte in plasma) after the first dose of 5 μg and 10 μg tiotropium bromide
Time frame: Pre-dose and 5, 15, 30 min and 1, 2, 4, 6 hours after treatment on Day1
MRTih (mean residence time of the analyte in the body after inhalation) after the first dose of 5 μg and 10 μg tiotropium bromide
Time frame: Pre-dose and 5, 15, 30 min and 1, 2, 4, 6 hours after treatment on Day1
CL/F (apparent clearance of the analyte in the plasma after extravascular administration) after the first dose of 5 μg and 10 μg tiotropium bromide
Time frame: Pre-dose and 5, 15, 30 min and 1, 2, 4, 6 hours after treatment on Day1
Vz/F (apparent volume of distribution of the analyte during the terminal phase λz following an extravascular dose) after the first dose of 5 μg and 10 μg tiotropium bromide
Time frame: Pre-dose and 5, 15, 30 min and 1, 2, 4, 6 hours after treatment on Day1
CLR,t1- t2 (renal clearance of the analyte in plasma from the time point t1 to time point t2) after the first dose of 5 μg and 10 μg tiotropium bromide
Time frame: Pre-dose and 5, 15, 30 min and 1, 2, 4, 6 hours after treatment on Day1
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Time frame: Pre-dose and 5, 15, 30 min and 1, 2, 4, 6 hours after treatment on Day 28
tmax,ss (time from last dosing to maximum concentration of the analyte in plasma at steady state)
Time frame: Pre-dose and 5, 15, 30 min and 1, 2, 4, 6 hours after treatment on Day 28
Cmin,ss (minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval τ)
Time frame: Pre-dose and 5, 15, 30 min and 1, 2, 4, 6 hours after treatment on Day 28
Cpre,ss(predose concentration of the analyte in plasma at steady state immediately before administration of the next dose)
Time frame: Pre-dose and 5, 15, 30 min and 1, 2, 4, 6 hours after treatment on Day 28
AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ)
Time frame: Pre-dose and 5, 15, 30 min and 1, 2, 4, 6 hours after treatment on Day 28
λz,ss (terminal rate constant in plasma at steady state)
Time frame: Pre-dose and 5, 15, 30 min and 1, 2, 4, 6 hours after treatment on Day 28
t1/2,ss (terminal half-life of the analyte in plasma at steady state)
Time frame: Pre-dose and 5, 15, 30 min and 1, 2, 4, 6 hours after treatment on Day 28
MRTih,ss (mean residence time of the analyte in the body after 14 administrations at steady state)
Time frame: Pre-dose and 5, 15, 30 min and 1, 2, 4, 6 hours after treatment on Day 28
CL/F,ss (apparent clearance of the analyte in the plasma at steady state following extravascular multiple dose administration)
Time frame: Pre-dose and 5, 15, 30 min and 1, 2, 4, 6 hours after treatment on Day 28
Vz/F,ss (apparent volume of distribution during the terminal phase λz at steady state following extravascular administration)
Time frame: Pre-dose and 5, 15, 30 min and 1, 2, 4, 6 hours after treatment on Day 28
Aet1-t2,ss (amount of analyte that is eliminated in urine at steady state from the time point t1 to time point t2)
Time frame: Pre-dose and 0-2, 2-4 and 4-8 hours after treatment on Day 28
fet1-t2,ss (fraction of analyte eliminated in urine at steady state from time point t1 to time point t2)
Time frame: Pre-dose and 0-2, 2-4 and 4-8 hours after treatment on Day 28
CLR,t1-t2,ss (renal clearance of the analyte in plasma from the time point t1 until the time point t2 at steady state)
Time frame: Pre-dose and 5, 15, 30 min and 1, 2, 4, 6 hours after treatment on Day 28
Accumulation Ratio (R)A,Cmax,28 based on Cmax
Time frame: 28 days
Accumulation Ratio (R)A,AUC,28 based on AUC0-τ
Time frame: 28 days
Linearity index (LI)
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2014.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Tiotropium bromide low, Tiotropium bromide medium and Tiotropium bromide high in people with Cystic Fibrosis, run by Boehringer Ingelheim.
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 11 inclusion and 10 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 24 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Changes from baseline in physical examination (time frame: Baseline, Day 1 and 28). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2014.