NCT00535366

Brief Summary

This efficacy and safety study compares four different combinations of blinded inhaled steroid treatments on top of open-label tiotropium and salmeterol in patients with chronic obstructive pulmonary disease (COPD). The primary objective is the effect on lung function parameters.

Trial Health

85
On Track

Trial Health Score

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

Enrollment
103

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
4 countries

12 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

First Submitted

Initial submission to the registry

September 25, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 26, 2007

Completed
5 days until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Last Updated

May 30, 2014

Status Verified

May 1, 2014

Enrollment Period

11 months

First QC Date

September 25, 2007

Last Update Submit

May 22, 2014

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

  • Trough FEV1 response at the end of each 4 week period of randomised treatment

    4 weeks

Secondary Outcomes (14)

  • Trough forced vital capacity (FVC) response after 4 weeks of each blinded treatment

    after 4 weeks of each blinded treatment

  • All adverse events

    24 weeks

  • Pulse rate and blood pressure (seated)

    24 weeks

  • FEV1 and FVC morning peak response

    day 1 and day 28 of each blinded treatment

  • FEV1 and FVC evening peak response

    day 1 and day 28 of each blinded treatment

  • +9 more secondary outcomes

Study Arms (4)

Tiotropium+salmeterol+fluticasone

EXPERIMENTAL
Drug: TiotropiumDrug: SalmeterolDrug: Fluticasone

Tiotropium+salmeterol+ciclesonide low

EXPERIMENTAL
Drug: TiotropiumDrug: SalmeterolDrug: Ciclesonide low

Tiotropium+salmeterol+ciclesonide high

EXPERIMENTAL
Drug: TiotropiumDrug: SalmeterolDrug: Ciclesonide high

Placebo

PLACEBO COMPARATOR
Drug: TiotropiumDrug: SalmeterolDrug: Placebo

Interventions

TiotropiumDRUG

Oral inhalation by HandiHaler® device

PlaceboTiotropium+salmeterol+ciclesonide highTiotropium+salmeterol+ciclesonide lowTiotropium+salmeterol+fluticasone
SalmeterolDRUG

Oral inhalation from Diskus®

PlaceboTiotropium+salmeterol+ciclesonide highTiotropium+salmeterol+ciclesonide lowTiotropium+salmeterol+fluticasone
FluticasoneDRUG

Oral inhalation from metered dose inhaler (MDI)

Tiotropium+salmeterol+fluticasone
Ciclesonide lowDRUG

Oral inhalation from MDI

Tiotropium+salmeterol+ciclesonide low
Ciclesonide highDRUG

Oral inhalation from MDI

Tiotropium+salmeterol+ciclesonide high
PlaceboDRUG

Oral inhalation from MDI

Placebo

Eligibility Criteria

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

You may qualify if:

  • Relatively stable, moderate to severe COPD
  • Male or female patients 40 years of age or older.
  • Current or ex-smokers with a smoking history of more than 10 pack years

You may not qualify if:

  • Other significant disease that can influence the study results or be a safety risk for the patient
  • Other medication that can influence the study results
  • Hypersensitivity to the study medication
  • Patients with unstable COPD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

1249.1.32003 Boehringer Ingelheim Investigational Site

Genk, Belgium

Location

1249.1.32001 Boehringer Ingelheim Investigational Site

Ghent, Belgium

Location

1249.1.32002 Boehringer Ingelheim Investigational Site

Hasselt, Belgium

Location

1249.1.32004 Boehringer Ingelheim Investigational Site

Ostend, Belgium

Location

1249.1.45001 Boehringer Ingelheim Investigational Site

Aarhus C, Denmark

Location

1249.1.49001 Boehringer Ingelheim Investigational Site

Großhansdorf, Germany

Location

1249.1.49002 Boehringer Ingelheim Investigational Site

Mannheim, Germany

Location

1249.1.49003 Boehringer Ingelheim Investigational Site

Weinheim, Germany

Location

1249.1.31002 Boehringer Ingelheim Investigational Site

Eindhoven, Netherlands

Location

1249.1.31003 Boehringer Ingelheim Investigational Site

Harderwijk, Netherlands

Location

1249.1.31001 Boehringer Ingelheim Investigational Site

Heerlen, Netherlands

Location

1249.1.31004 Boehringer Ingelheim Investigational Site

Veldhoven, Netherlands

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium BromideSalmeterol XinafoateFluticasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Scopolamine DerivativesTropanesAzabicyclo CompoundsAza CompoundsOrganic ChemicalsAlkaloidsHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-RingAlbuterolEthanolaminesAmino AlcoholsAlcoholsAminesPhenethylaminesEthylaminesAndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 25, 2007

First Posted

September 26, 2007

Study Start

October 1, 2007

Primary Completion

September 1, 2008

Last Updated

May 30, 2014

Record last verified: 2014-05

Locations

BE(4)DK(1)DE(3)NL(4)