Pulmonary Disease, Chronic ObstructivePhase 3NCT00673478
Tiotropium and Salmeterol PK Study in COPD Patients
A Phase 3 study testing Tiotropium+Salmeterol, Salmeterol and Tiotropium in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 3 sites in 2 countries.
Trial summary
The primary objective of this study is to characterize the pharmacokinetics (i.e. systemic exposure to tiotropium and salmeterol) of tiotropium qd + salmeterol qd or bid versus tiotropium qd and salmeterol bid following 4-week treatment periods in patients with chronic obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Tiotropium+Salmeterol, Salmeterol and Tiotropium
- How many people
- 50 participants
- Where
- 3 sitesin 2 countries
- Study dates
- May 2008to Jun 2009
- Phase
- Phase 3
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- COPD patients of >= 40 years old with moderate to severe COPD who are current or ex-smokers with a smoking history of at least 10 pack-years
Who cannot join
- Recent history of myocardial infarction, life-threatening cardiac arrhythmia or hospitalisation for cardiac failure
- History of asthma
- Malignancy requiring treatment within past 5 years
- Life-threatening pulmonary obstruction, cystic fibrosis or clinically evident bronchiectasis
- Known active tuberculosis
- Pregnant or nusing women
- Known hypersensitivity to components of the study medication
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Belgium2 sites
1184.24.32001 Boehringer Ingelheim Investigational Site
Genk
1184.24.32002 Boehringer Ingelheim Investigational Site
Hasselt
Netherlands1 site
1184.24.31001 Boehringer Ingelheim Investigational Site
Heerlen
About this study
Official title: A Randomised, Open-label, 4-way Crossover Study to Characterize the Pharmacokinetics, Safety and Efficacy of FDC Tiotropium/Salmeterol, Tiotropium, Salmeterol and a Free Combination of Tiotropium Plus Salmeterol Following 4-week Treatment Periods in Patients With COPD.
The primary objective of this study is to characterize the pharmacokinetics (i.e. systemic exposure to tiotropium and salmeterol) of tiotropium qd + salmeterol qd or bid versus tiotropium qd and salmeterol bid following 4-week treatment periods in patients with chronic obstructive pulmonary disease (COPD).
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Tiotropium+Salmeterol, Salmeterol, Tiotropium
- 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+SalmeterolDrug
SalmeterolDrug
TiotropiumDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the concentration-time curve (AUC0-∞ ) of tiotropium in plasma
Measured: 16 weeks
Maximum measured concentration of tiotropium in plasma (Cmax)
Measured: 16 weeks
Amount of tiotropium that was eliminated in urine (Ae0-8) from time point 0 to 8 hours post-inhalation
Measured: 16 weeks
AUC0-∞ of salmeterol in plasma
Measured: 16 weeks
Cmax salmeterol in plasma
Measured: 16 weeks
Secondary outcomes (18)
Area under the concentration time curve (AUCt1-t2) of tiotropium and salmeterol in plasma over the time interval t1 to t2 for time intervals 0 to 4, 0 to 6, and 0 to 8 hours after inhalation (AUC0-4, AUC0-6, and AUC0-8)
Measured: 16 weeks
Time from dosing to the maximum concentration of tiotropium and salmeterol in plasma (tmax)
Measured: 16 weeks
Terminal rate constant in plasma (λz)
Measured: 16 weeks
Terminal half-life (t½) of tiotropium and salmeterol in plasma)
Measured: 16 weeks
Mean residence time (MRTih) of tiotropium and salmeterol in the body after inhalational administration
Measured: 16 weeks
Apparent clearance (CL/F) of tiotropium and salmeterol in plasma after extravascular administration)
Measured: 16 weeks
Apparent volume of distribution (Vz/F) during the terminal phase (λz) following an extravascular dose)
Measured: 16 weeks
Amount of tiotropium that is eliminated in urine from the time point t1 to time point t2 (Aet1-t2) (Ae0-2, Ae2-4, Ae4-8, Ae0-8)
Measured: 16 weeks
Fraction of tiotropium eliminated in urine from time point t1 to time point t2 (fet1-t2) (fe0-2, fe2-4, fe4-8, fe0-8)
Measured: 16 weeks
Renal clearance of tiotropium from the time point t1 until the time point t2 (CLR,t1-t2) (CLR,0-2, CLR, 2-4, CLR,4-8, CLR,0-8)
Measured: 16 weeks
All adverse events
Measured: 20 weeks
Blood pressure (seated) recorded in conjunction with 12-lead ECG recordings pre-dose and following the morning dose of randomized treatment
Measured: 20 weeks
Number of patients with abnormalities in routine blood chemistry, haematology and urinalysis
Measured: 16 weeks
Trough forced expiratory volume in one second (FEV1)
Measured: 16 weeks
Trough forced vital capacity (FVC)
Measured: 16 weeks
FEV1 area under the curve 0 to 8 hours (FEV1 AUC0-8h)
Measured: 16 weeks
FVC area under the curve 0 to 8 hours (FVC AUC0-8h)
Measured: 16 weeks
Individual FEV1and FVC measurements at each time point at the end of each 4-week treatment period.
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2008 (estimated)
- Study startMay 2008
- Primary completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 3
- Primary purpose
- Treatment
- Intervention model
- Crossover
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00673478
- Sponsor's protocol ID
- 1184.24
- Other IDs
- EudraCT 2007-000207-15
- Status last verified
- Apr 2014
- First submitted
- 6 May 2008
- Last updated
- 16 May 2014
- Results posted
- No
Publications
Parigi TL, Nardone OM, Lisa M, Massimino L, Gabbiadini R, Innocenti T, Bertani L, Del Gaudio A, Florez P, Bertin L, Barberio B, Hupe M, Lopetuso L, Allocca M, D'Amico F, Furfaro F, Zilli A, Fiorino G, Ungaro F, Castiglione F, Savarino E, Dragoni G, Scaldaferri F, Armuzzi A, Peyrin-Biroulet L, Jairath V, Pizarro TT, Danese S. The Impact of E-Cigarettes and Heat-Not-Burn Tobacco on Postoperative Recurrence of Crohn's Disease: A Multicenter International Study. Am J Gastroenterol. 2026 Aug 1;121(8):1954-1962. doi: 10.14309/ajg.0000000000003810. Epub 2025 Oct 24.
PubMed 41134080
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 Randomised, Open-label, 4-way Crossover Study to Characterize the Pharmacokinetics, Safety and Efficacy of FDC Tiotropium/Salmeterol, Tiotropium, Salmeterol and a Free Combination of Tiotropium Plus Salmeterol Following 4-week Treatment Periods in Patients With COPD.
- ClinicalTrials.gov ID
- NCT00673478
- Acronym / sponsor ID
- 1184.24
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Jun 2009 (actual)
- First posted
- 7 May 2008 (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.
The primary objective of this study is to characterize the pharmacokinetics (i.e. systemic exposure to tiotropium and salmeterol) of tiotropium qd + salmeterol qd or bid versus tiotropium qd and salmeterol bid following 4-week treatment periods in patients with chronic obstructive pulmonary disease (COPD).
Study design
- Primary purpose
- Treatment
- Intervention model
- Crossover
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- COPD patients of >= 40 years old with moderate to severe COPD who are current or ex-smokers with a smoking history of at least 10 pack-years
Key exclusion criteria (7 listed)
- Recent history of myocardial infarction, life-threatening cardiac arrhythmia or hospitalisation for cardiac failure
- History of asthma
- Malignancy requiring treatment within past 5 years
- Life-threatening pulmonary obstruction, cystic fibrosis or clinically evident bronchiectasis
- Known active tuberculosis
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+Salmeterol | Drug | – |
| Salmeterol | Drug | – |
| Tiotropium | Drug | – |
Primary outcome
Area under the concentration-time curve (AUC0-∞ ) of tiotropium in plasma
Time frame: 16 weeks
Maximum measured concentration of tiotropium in plasma (Cmax)
Time frame: 16 weeks
Amount of tiotropium that was eliminated in urine (Ae0-8) from time point 0 to 8 hours post-inhalation
Time frame: 16 weeks
AUC0-∞ of salmeterol in plasma
Time frame: 16 weeks
Cmax salmeterol in plasma
Time frame: 16 weeks
18 secondary outcomes
Area under the concentration time curve (AUCt1-t2) of tiotropium and salmeterol in plasma over the time interval t1 to t2 for time intervals 0 to 4, 0 to 6, and 0 to 8 hours after inhalation (AUC0-4, AUC0-6, and AUC0-8)
Time frame: 16 weeks
Time from dosing to the maximum concentration of tiotropium and salmeterol in plasma (tmax)
Time frame: 16 weeks
Terminal rate constant in plasma (λz)
Time frame: 16 weeks
Terminal half-life (t½) of tiotropium and salmeterol in plasma)
Time frame: 16 weeks
Mean residence time (MRTih) of tiotropium and salmeterol in the body after inhalational administration
Time frame: 16 weeks
Apparent clearance (CL/F) of tiotropium and salmeterol in plasma after extravascular administration)
Time frame: 16 weeks
Apparent volume of distribution (Vz/F) during the terminal phase (λz) following an extravascular dose)
Time frame: 16 weeks
Amount of tiotropium that is eliminated in urine from the time point t1 to time point t2 (Aet1-t2) (Ae0-2, Ae2-4, Ae4-8, Ae0-8)
Time frame: 16 weeks
Fraction of tiotropium eliminated in urine from time point t1 to time point t2 (fet1-t2) (fe0-2, fe2-4, fe4-8, fe0-8)
Time frame: 16 weeks
Renal clearance of tiotropium from the time point t1 until the time point t2 (CLR,t1-t2) (CLR,0-2, CLR, 2-4, CLR,4-8, CLR,0-8)
Time frame: 16 weeks
All adverse events
Time frame: 20 weeks
Blood pressure (seated) recorded in conjunction with 12-lead ECG recordings pre-dose and following the morning dose of randomized treatment
Time frame: 20 weeks
Number of patients with abnormalities in routine blood chemistry, haematology and urinalysis
Time frame: 16 weeks
Trough forced expiratory volume in one second (FEV1)
Time frame: 16 weeks
Trough forced vital capacity (FVC)
Time frame: 16 weeks
FEV1 area under the curve 0 to 8 hours (FEV1 AUC0-8h)
Time frame: 16 weeks
FVC area under the curve 0 to 8 hours (FVC AUC0-8h)
Time frame: 16 weeks
Individual FEV1and FVC measurements at each time point at the end of each 4-week treatment period.
Time frame: 16 weeks
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 16 May 2014.
- Derived from this study: PubMed 41134080Parigi TL, Nardone OM, Lisa M, Massimino L, Gabbiadini R, Innocenti T, Bertani L, Del Gaudio A, Florez P, Bertin L, Barberio B, Hupe M, Lopetuso L, Allocca M, D'Amico F, Furfaro F, Zilli A, Fiorino G, Ungaro F, Castiglione F, Savarino E, Dragoni G, Scaldaferri F, Armuzzi A, Peyrin-Biroulet L, Jairath V, Pizarro TT, Danese S. The Impact of E-Cigarettes and Heat-Not-Burn Tobacco on Postoperative Recurrence of Crohn's Disease: A Multicenter International Study. Am J Gastroenterol. 2026 Aug 1;121(8):1954-1962. doi: 10.14309/ajg.0000000000003810. Epub 2025 Oct 24.
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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
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tiotropium+Salmeterol, Salmeterol and Tiotropium in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 3 sites in 2 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 1 inclusion and 7 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 3 sites in Belgium, Netherlands. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Area under the concentration-time curve (AUC0-∞ ) of tiotropium in plasma (time frame: 16 weeks). The study lists 5 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 NCT00673478, which also lists 1 linked publication.
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.