Pulmonary Disease, Chronic ObstructivePhase 2NCT01222533

Tiotropium Respimat Pharmacokinetic Study in COPD

A Phase 2 study testing Tiotropium medium, Tiotropium low and Tiotropium high in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 11 sites in 5 countries.

Completed

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

Official record

Search all trials

Trial summary

Who is it for?: Ages 40 years and older
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: Tiotropium medium, Tiotropium low and Tiotropium high
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 154 participants
Where: 11 sitesin 5 countries
Study dates: Oct 2010to Nov 2011
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

All patient must sign an informed consent consistent with IInternational Conference on Harmonisation- Good Clinical Practice (ICH-GCP) guidelines and local legislation prior to any study-related procedures, including medication washout and restrictions.
Relatively stable, moderate to very severe Chronic Obstructive Pulmonary Disease (COPD)
Current or ex-smokers (smoking history of at least 10 pack years)
Able to perform lung function tests
Able to use study inhalers

Who cannot join

Significant diseases other than COPD
Recent myocardial infarction, unstable or life-threatening cardiac arrhythmia, hospitalisation for cardiac failure.
Malignancy requiring resection, radiation therapy or chemotherapy within the last 5 years
History of asthma, life-threatening pulmonary obstruction, cystic fibrosis or clinically evident bronchiectasis 5 Active tuberculosis
6. History of alcohol or drug abuse 7. Pulmonary resection 8. Recent completion of a pulmonary rehabilitation program or current participation which will not be continued 9. Daytime oxygen therapy for more than 1 hour per day. 10. Use of other investigational drugs, restrictions on the use of some respiratory medications during the study period.
11. Current participation in another clinical trial 12. Pregnant or nursing women 13. Women of childbearing potential not using a highly effective method of contraception (e.g: implants, injectable, oral contraceptives)

Trial locations and contacts

11 sites in 5 countries.

Country

City, postcode or hospital

11 sites in 5 countries

Belgium3 sites

205.458.32003 Boehringer Ingelheim Investigational Site
Genk
205.458.32001 Boehringer Ingelheim Investigational Site
Ghent
205.458.32002 Boehringer Ingelheim Investigational Site
Hasselt

Other trials in Belgium

Denmark3 sites

205.458.45001 Boehringer Ingelheim Investigational Site
Copenhagen K
205.458.45003 Boehringer Ingelheim Investigational Site
København NV
205.458.45002 Boehringer Ingelheim Investigational Site
Odense C

Other trials in Denmark

Finland2 sites

205.458.35801 Boehringer Ingelheim Investigational Site
Helsinki
205.458.35802 Boehringer Ingelheim Investigational Site
Tampere

Other trials in Finland

Netherlands2 sites

205.458.31001 Atrium Medisch Centrum Parkstad
Heerlen
205.458.31002 Ommelander ziekenhuis groep, locatie Lucas
Winschoten

Other trials in Netherlands

Germany1 site

205.458.49001 Boehringer Ingelheim Investigational Site
Hanover

Other trials in Germany

About this study

Official title: A Multicenter, Randomised, Placebo- and Active-controlled, 5 Way, Crossover Trial to Characterise the Pharmacokinetics and Evaluate the Bronchodilator Efficacy and Safety of Once-daily Tiotropium Delivered (Double-blind) From the Respimat Inhaler as Solution for Inhalation (1.25, 2.5, 5 mcg or Placebo) and as Inhalation Powder (18mcg) From the HandiHaler (Open Label) After 4 Week-treatment Periods in Patients With Chronic Obstructive Pulmonary Disease (COPD)

The purpose of this study is compare the effect of different doses of tiotropium delivered by the HandiHaler and Respimat device on lung function. Additionally, the study will investigate the pharmacokinetic profile of these different doses. Studying the pharmacokinetic profile shows what happens to the medication in the body over a period of hours and provides information on potential effects of the medication.

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: Tiotropium medium, Tiotropium low, Tiotropium high, Tiotropium 18mcg, Tiotropium placebo
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

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

Tiotropium mediumDrug
Tiotropium inhalation solution medium dose
Tiotropium lowDrug
Tiotropium inhalation solution low dose
Tiotropium highDrug
Tiotropium inhalation solution high dose
Tiotropium 18mcgDrug
Tiotropium inhalation powder 18mcg
Tiotropium placeboDrug
Placebo inhalation solution

Study groups in NCT01222533
Study group	Role	What they receive
Tiotropium low	Experimental	Tiotropium inhalation solution low dose Receives: Drug: Tiotropium low
Tiotropium medium	Experimental	Tiotropium inhalation solution medium dose Receives: Drug: Tiotropium medium
Tiotropium high	Experimental	Tiotropium inhalation solution high dose Receives: Drug: Tiotropium high
Tiotropium 18mcg	Active comparator	Tiotropium inhalation powder 18mcg Receives: Drug: Tiotropium 18mcg
Tiotropium placebo	Placebo comparator	Placebo inhalation solution Receives: Drug: Tiotropium placebo

What is being measured

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

Maximum Plasma Concentration at Steady-state (Cmax,ss)
Cmax,ss is the maximum measured concentration of tiotropium in plasma at steady-state.
Measured: Based on blood sampling for PK assessments done at 4 weeks at the following time points: 5 minutes (min) before study drug (baseline) and at 2 min , 5 min, 7 min, 9 min, 12 min, 15 min, 20 min, 30 min, 40 min, 1 hour (h), 2 h, 4 h and 6 h post dosing.
Area Under the Curve 0 to 6 Hours at Steady-state (AUC0-6h,ss)
AUC0-6h,ss is the area under the concentration time curve of tiotropium in plasma over the time interval 0 to 6 hours post-dose at steady-state. AUC0-6h,ss was calculated using the linear up/log down algorithm.
Measured: Based on blood sampling for PK assessments done at 4 weeks at the following time points: 5 minutes (min) before study drug (baseline) and at 2 min , 5 min, 7 min, 9 min, 12 min, 15 min, 20 min, 30 min, 40 min, 1 hour (h), 2 h, 4 h and 6 h post dosing.

Secondary outcomes (14)

Trough Forced Expiratory Volume in One Second (FEV1) at the End of Each Treatment Period
Defined as FEV1 measured just prior to the last administration of the morning dose of the randomised treatment. Means are adjusted for sequence, patients within sequences, period and treatment.
Measured: 4 weeks
FEV1 Area Under the Curve 0 to 6 Hours (AUC0-6h) at the End of Each Treatment Period
FEV1 AUC0-6h calculated from zero time to 6 hours using the trapezoidal rule divided by 6 hours. Trough FEV1 will be assigned to zero time. Means are adjusted for sequence, patients within sequences, period and treatment.
Measured: 4 weeks
FEV1 Area Under the Curve 0 to 3 Hours (AUC0-3h) at the End of Each Treatment Period
FEV1 AUC0-3h calculated from zero time to 3 hours using the trapezoidal rule divided by 3 hours. Trough FEV1 will be assigned to zero time. Means are adjusted for sequence, patients within sequences, period and treatment.
Measured: 4 weeks
Trough Forced Vital Capacity (FVC) at the End of Each Treatment Period
Defined as the pre-dose FVC measured just prior to the last administration of the morning dose of the randomised treatment. Means are adjusted for sequence, patients within sequences, period and treatment.
Measured: 4 weeks
FVC AUC0-6h at the End of Each Treatment Period
FVC AUC0-6h calculated from zero time to 6 hours using the trapezoidal rule divided by 6 hours. Trough FVC will be assigned to zero time. Means are adjusted for sequence, patients within sequences, period and treatment.
Measured: 4 weeks
FVC AUC0-3h at the End of Each Treatment Period
FVC AUC0-3h calculated from zero time to 3 hours using the trapezoidal rule divided by 3 hours. Trough FVC will be assigned to zero time. Means are adjusted for sequence, patients within sequences, period and treatment.
Measured: 4 weeks
FEV1 at Each Planned Time at the End of Each Treatment Period
Means are adjusted for period, planned time, period*planned time, patient*planned time and patient*treatment*planned time.
Measured: 4 weeks
FVC at Each Planned Time at the End of Each Treatment Period
Means are adjusted for period, planned time, period*planned time, patient*planned time and patient*treatment*planned time.
Measured: 4 weeks
Area Under the Curve 0 to 1 Hour at Steady-state (AUC0-1h,ss)
AUC0-1h,ss is the area under the concentration time curve of tiotropium in plasma over the time interval 0 to 1 hour post-dose at steady-state. AUC0-1h,ss was calculated using the linear up/log down algorithm.
Measured: Based on blood sampling for PK assessments done at 4 weeks at the following time points: 5 minutes (min) before study drug (baseline) and at 2 min , 5 min, 7 min, 9 min, 12 min, 15 min, 20 min, 30 min, 40 min, 1 hour (h), 2 h, 4 h and 6 h post dosing.
Time to Maximum Plasma Concentration at Steady-state (Tmax,ss)
Tmax,ss is the time from dosing to the maximum concentration of tiotropium in plasma-venous blood at steady-state.
Measured: Based on blood sampling for PK assessments done at 4 weeks at the following time points: 5 min before first dosing of study drug (baseline) and at 2 min , 5 min, 7 min, 9 min, 12 min, 15 min, 20 min, 30 min, 40 min, 1 h, 2 h, 4 h and 6 h post dosing.
Amount of Drug Eliminated in Urine at Steady-state (Ae0-6h,ss)
Total quantity of the analyte that is excreted in urine over the time interval 0 to 6 hours at steady state.
Measured: Based on urine sampling for PK assessments done at 4 weeks in the following intervals: -1 to 0 hour (h), 0 to 2 h and 2 to 6 h post-dosing.
Pre-dose Plasma Concentration at Steady-state (Cpre,ss)
Cpre,ss is the measured concentration of tiotropium in plasma before dosing at steady-state.
Measured: Based on blood sampling for PK assessments done at 4 weeks at the following time point: 5 minutes (min) before first dosing of study drug (baseline)
Renal Clearance at Steady-state (CL R,0-6h,ss)
Renal clearance of the drug over the time interval 0 to 6 hours at steady-state. CL R,0-6h,ss was calculated as the quotient of Ae0-6h,ss and AUC0-6h,ss.
Measured: Based on blood and urine sampling for PK assessments done at 4 weeks over 6 h post dosing.
Minimum Plasma Concentration at Steady-state (Cmin,ss)
Cmin,ss is the minimum measured concentration of tiotropium in plasma at steady-state.
Measured: Based on blood sampling for PK assessments done at 4 weeks at the following time points: 5 min before first dosing of study drug (baseline) and at 2 min , 5 min, 7 min, 9 min, 12 min, 15 min, 20 min, 30 min, 40 min, 1 h, 2 h, 4 h and 6 h post dosing.

Timeline

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

Oct 2010Nov 2011

First posted18 Oct 2010 (estimated)
Study startOct 2010
Primary completionNov 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Enrolment: 154 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01222533
Sponsor's protocol ID: 205.458
Other IDs: 2009-016251-21, 2009
Status last verified: Aug 2013
First submitted: 15 Oct 2010
Last updated: 16 May 2014
Results posted: Yes, on ClinicalTrials.gov

Publications

Hohlfeld JM, Furtwaengler A, Konen-Bergmann M, Wallenstein G, Walter B, Bateman ED. Cardiac safety of tiotropium in patients with COPD: a combined analysis of Holter-ECG data from four randomised clinical trials. Int J Clin Pract. 2015 Jan;69(1):72-80. doi: 10.1111/ijcp.12596. Epub 2014 Dec 11.
PubMed 25496316
Hohlfeld JM, Sharma A, van Noord JA, Cornelissen PJ, Derom E, Towse L, Peterkin V, Disse B. Pharmacokinetics and pharmacodynamics of tiotropium solution and tiotropium powder in chronic obstructive pulmonary disease. J Clin Pharmacol. 2014 Apr;54(4):405-14. doi: 10.1002/jcph.215. Epub 2013 Nov 27.
PubMed 24165906

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pulmonary Disease, Chronic Obstructive trials

Study at a glance

From the registry record, last updated by the sponsor on 16 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomised, Placebo- and Active-controlled, 5 Way, Crossover Trial to Characterise the Pharmacokinetics and Evaluate the Bronchodilator Efficacy and Safety of Once-daily Tiotropium Delivered (Double-blind) From the Respimat Inhaler as Solution for Inhalation (1.25, 2.5, 5 mcg or Placebo) and as Inhalation Powder (18mcg) From the HandiHaler (Open Label) After 4 Week-treatment Periods in Patients With Chronic Obstructive Pulmonary Disease (COPD)
ClinicalTrials.gov ID: NCT01222533
Acronym / sponsor ID: 205.458
Conditions: Pulmonary Disease, Chronic Obstructive
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 154 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Oct 2010
Primary completion: Nov 2011 (actual)
First posted: 18 Oct 2010 (estimated)
Results: Posted 10 Dec 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Number of arms: 5

Arm	Type	Receives
Tiotropium low	Experimental	Drug: Tiotropium lowTiotropium inhalation solution low dose
Tiotropium medium	Experimental	Drug: Tiotropium mediumTiotropium inhalation solution medium dose
Tiotropium high	Experimental	Drug: Tiotropium highTiotropium inhalation solution high dose
Tiotropium 18mcg	Active comparator	Drug: Tiotropium 18mcgTiotropium inhalation powder 18mcg
Tiotropium placebo	Placebo comparator	Drug: Tiotropium placeboPlacebo inhalation solution

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

All patient must sign an informed consent consistent with IInternational Conference on Harmonisation- Good Clinical Practice (ICH-GCP) guidelines and local legislation prior to any study-related procedures, including medication washout and restrictions.
Relatively stable, moderate to very severe Chronic Obstructive Pulmonary Disease (COPD)
Current or ex-smokers (smoking history of at least 10 pack years)
Able to perform lung function tests
Able to use study inhalers

Key exclusion criteria (6 listed)

Significant diseases other than COPD
Recent myocardial infarction, unstable or life-threatening cardiac arrhythmia, hospitalisation for cardiac failure.
Malignancy requiring resection, radiation therapy or chemotherapy within the last 5 years
History of asthma, life-threatening pulmonary obstruction, cystic fibrosis or clinically evident bronchiectasis 5 Active tuberculosis
6. History of alcohol or drug abuse 7. Pulmonary resection 8. Recent completion of a pulmonary rehabilitation program or current participation which will not be continued 9. Daytime oxygen therapy for more than 1 hour per day. 10. Use of other investigational drugs, restrictions on the use of some respiratory medications during the study period.

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 mediumTiotropium inhalation solution medium dose	Drug	Tiotropium medium
Tiotropium lowTiotropium inhalation solution low dose	Drug	Tiotropium low
Tiotropium highTiotropium inhalation solution high dose	Drug	Tiotropium high
Tiotropium 18mcgTiotropium inhalation powder 18mcg	Drug	Tiotropium 18mcg
Tiotropium placeboPlacebo inhalation solution	Drug	Tiotropium placebo

Primary outcome

Maximum Plasma Concentration at Steady-state (Cmax,ss)
Time frame: Based on blood sampling for PK assessments done at 4 weeks at the following time points: 5 minutes (min) before study drug (baseline) and at 2 min , 5 min, 7 min, 9 min, 12 min, 15 min, 20 min, 30 min, 40 min, 1 hour (h), 2 h, 4 h and 6 h post dosing.
Cmax,ss is the maximum measured concentration of tiotropium in plasma at steady-state.
Area Under the Curve 0 to 6 Hours at Steady-state (AUC0-6h,ss)
Time frame: Based on blood sampling for PK assessments done at 4 weeks at the following time points: 5 minutes (min) before study drug (baseline) and at 2 min , 5 min, 7 min, 9 min, 12 min, 15 min, 20 min, 30 min, 40 min, 1 hour (h), 2 h, 4 h and 6 h post dosing.
AUC0-6h,ss is the area under the concentration time curve of tiotropium in plasma over the time interval 0 to 6 hours post-dose at steady-state. AUC0-6h,ss was calculated using the linear up/log down algorithm.

14 secondary outcomes

Trough Forced Expiratory Volume in One Second (FEV1) at the End of Each Treatment Period
Time frame: 4 weeks
FEV1 Area Under the Curve 0 to 6 Hours (AUC0-6h) at the End of Each Treatment Period
Time frame: 4 weeks
FEV1 Area Under the Curve 0 to 3 Hours (AUC0-3h) at the End of Each Treatment Period
Time frame: 4 weeks
Trough Forced Vital Capacity (FVC) at the End of Each Treatment Period
Time frame: 4 weeks
FVC AUC0-6h at the End of Each Treatment Period
Time frame: 4 weeks
FVC AUC0-3h at the End of Each Treatment Period
Time frame: 4 weeks
FEV1 at Each Planned Time at the End of Each Treatment Period
Time frame: 4 weeks
FVC at Each Planned Time at the End of Each Treatment Period
Time frame: 4 weeks
Area Under the Curve 0 to 1 Hour at Steady-state (AUC0-1h,ss)
Time frame: Based on blood sampling for PK assessments done at 4 weeks at the following time points: 5 minutes (min) before study drug (baseline) and at 2 min , 5 min, 7 min, 9 min, 12 min, 15 min, 20 min, 30 min, 40 min, 1 hour (h), 2 h, 4 h and 6 h post dosing.
Time to Maximum Plasma Concentration at Steady-state (Tmax,ss)
Time frame: Based on blood sampling for PK assessments done at 4 weeks at the following time points: 5 min before first dosing of study drug (baseline) and at 2 min , 5 min, 7 min, 9 min, 12 min, 15 min, 20 min, 30 min, 40 min, 1 h, 2 h, 4 h and 6 h post dosing.
Amount of Drug Eliminated in Urine at Steady-state (Ae0-6h,ss)
Time frame: Based on urine sampling for PK assessments done at 4 weeks in the following intervals: -1 to 0 hour (h), 0 to 2 h and 2 to 6 h post-dosing.
Pre-dose Plasma Concentration at Steady-state (Cpre,ss)
Time frame: Based on blood sampling for PK assessments done at 4 weeks at the following time point: 5 minutes (min) before first dosing of study drug (baseline)
Renal Clearance at Steady-state (CL R,0-6h,ss)
Time frame: Based on blood and urine sampling for PK assessments done at 4 weeks over 6 h post dosing.
Minimum Plasma Concentration at Steady-state (Cmin,ss)
Time frame: Based on blood sampling for PK assessments done at 4 weeks at the following time points: 5 min before first dosing of study drug (baseline) and at 2 min , 5 min, 7 min, 9 min, 12 min, 15 min, 20 min, 30 min, 40 min, 1 h, 2 h, 4 h and 6 h post dosing.

Results and safety

Results posted to the registry on 10 Dec 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Study Overall	154	140

Primary outcome: Maximum Plasma Concentration at Steady-state (Cmax,ss)

Time frame: Based on blood sampling for PK assessments done at 4 weeks at the following time points: 5 minutes (min) before study drug (baseline) and at 2 min , 5 min, 7 min, 9 min, 12 min, 15 min, 20 min, 30 min, 40 min, 1 hour (h), 2 h, 4 h and 6 h post dosing.. Geometric mean (Geometric Coefficient of Variation). Unit: pg/ml

Measure	Placebo n = 0	Tio R1.25 n = 104	Tio R2.5 n = 110	Tio R5 n = 113	Tio HH18 n = 113
Value	–	2.81 (53.0)	5.07 (61.8)	10.5 (66.4)	12.9 (64.6)

Tio R5 vs Tio HH18: Geometric mean ratio (percentage): 80.66 (90% CI 73.49 to 88.52), p = 0.4423, ANOVA

Population analysed: Pharmacokinetic (PK) Set. This analysis set includes all patients in the treated set who had at least one blood sample drawn or one urine sample collected for PK analysis. Patients with an important protocol violation relevant to the PK population were excluded. No PK data for placebo. All patients with analysable data.

Primary outcome: Area Under the Curve 0 to 6 Hours at Steady-state (AUC0-6h,ss)

Measure	Placebo n = 0	Tio R1.25 n = 22	Tio R2.5 n = 76	Tio R5 n = 107	Tio HH18 n = 113
Value	–	10.0 (25.3)	12.8 (29.9)	22.1 (47.8)	28.4 (52.4)

Tio R5 vs Tio HH18: Geometric mean ratio (percentage): 75.99 (90% CI 70.44 to 81.98), p = 0.8683, ANOVA

Population analysed: PK Set. No PK data for Placebo. The low number of non-missing AUC0-6h,ss results for the Tio R 1.25 and Tio R 2.5 cohorts is due to the exclusion of results below the limit of quantification.

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4 weeks + 30 days if in last period. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	3 of 147 (2%)	20 of 147 (13.6%)	Not reported
Tio R1.25	2 of 147 (1.4%)	11 of 147 (7.5%)	Not reported
Tio R2.5	0 of 145 (0%)	4 of 145 (2.8%)	Not reported
Tio R5	3 of 150 (2%)	16 of 150 (10.7%)	Not reported
Tio HH18	2 of 146 (1.4%)	10 of 146 (6.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25496316Hohlfeld JM, Furtwaengler A, Konen-Bergmann M, Wallenstein G, Walter B, Bateman ED. Cardiac safety of tiotropium in patients with COPD: a combined analysis of Holter-ECG data from four randomised clinical trials. Int J Clin Pract. 2015 Jan;69(1):72-80. doi: 10.1111/ijcp.12596. Epub 2014 Dec 11.
Derived from this study: PubMed 24165906Hohlfeld JM, Sharma A, van Noord JA, Cornelissen PJ, Derom E, Towse L, Peterkin V, Disse B. Pharmacokinetics and pharmacodynamics of tiotropium solution and tiotropium powder in chronic obstructive pulmonary disease. J Clin Pharmacol. 2014 Apr;54(4):405-14. doi: 10.1002/jcph.215. Epub 2013 Nov 27.

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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.

Boehringer Ingelheim study chair

Boehringer Ingelheim

11 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tiotropium medium, Tiotropium low and Tiotropium high in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 11 sites in 5 countries.

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 5 inclusion and 6 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 16 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in Belgium, Denmark, Finland, Netherlands, 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Maximum Plasma Concentration at Steady-state (Cmax,ss) (time frame: Based on blood sampling for PK assessments done at 4 weeks at the following time points: 5 minutes (min) before study drug (baseline) and at 2 min , 5 min, 7 min, 9 min, 12 min, 15 min, 20 min, 30 min, 40 min, 1 hour (h), 2 h, 4 h and 6 h post dosing.). The study lists 2 primary outcomes in all. 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 NCT01222533, which also lists 2 linked publications.

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 16 May 2014.