NCT00673478

Brief 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).

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for phase_3

Geographic Reach
2 countries

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

May 6, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 7, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
Last Updated

May 16, 2014

Status Verified

April 1, 2014

Enrollment Period

1.1 years

First QC Date

May 6, 2008

Last Update Submit

April 30, 2014

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (5)

  • Area under the concentration-time curve (AUC0-∞ ) of tiotropium in plasma

    16 weeks

  • Maximum measured concentration of tiotropium in plasma (Cmax)

    16 weeks

  • Amount of tiotropium that was eliminated in urine (Ae0-8) from time point 0 to 8 hours post-inhalation

    16 weeks

  • AUC0-∞ of salmeterol in plasma

    16 weeks

  • Cmax salmeterol in plasma

    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)

    16 weeks

  • Time from dosing to the maximum concentration of tiotropium and salmeterol in plasma (tmax)

    16 weeks

  • Terminal rate constant in plasma (λz)

    16 weeks

  • Terminal half-life (t½) of tiotropium and salmeterol in plasma)

    16 weeks

  • Mean residence time (MRTih) of tiotropium and salmeterol in the body after inhalational administration

    16 weeks

  • +13 more secondary outcomes

Interventions

Tiotropium+SalmeterolDRUG
SalmeterolDRUG
TiotropiumDRUG

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

1184.24.32001 Boehringer Ingelheim Investigational Site

Genk, Belgium

Location

1184.24.32002 Boehringer Ingelheim Investigational Site

Hasselt, Belgium

Location

1184.24.31001 Boehringer Ingelheim Investigational Site

Heerlen, Netherlands

Location

Related Publications (1)

  • 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. 2025 Oct 24. doi: 10.14309/ajg.0000000000003810. Online ahead of print.

    PMID: 41134080DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Salmeterol XinafoateTiotropium Bromide

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AlbuterolEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylaminesScopolamine DerivativesTropanesAzabicyclo CompoundsAza CompoundsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-Ring

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

May 6, 2008

First Posted

May 7, 2008

Study Start

May 1, 2008

Primary Completion

June 1, 2009

Last Updated

May 16, 2014

Record last verified: 2014-04

Locations

BE(2)NL(1)