NCT00274053

Brief Summary

The purpose of this study is to investigate the effect of a 9-month treatment of tiotropium (SPIRIVA®) 18 mcg once daily on Health Related Quality of Life and lung function in patients with a Chronic Obstructive Pulmonary Disease.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
555

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Apr 2002

Geographic Reach
1 country

27 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

April 1, 2002

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2004

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

January 9, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 10, 2006

Completed
Last Updated

November 1, 2013

Status Verified

October 1, 2013

Enrollment Period

2 years

First QC Date

January 9, 2006

Last Update Submit

October 31, 2013

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

  • responder rate on SGRQ questionnaire (% of patients improved by more than 4 points)

Secondary Outcomes (1)

  • changes in SGRQ scores, VSRQ scores, spirometric parameters (FEV1, FVC, FIV1, SVC, IC) ; incidence, severity and duration of acute exacerbations, PGE

Interventions

tiotropiumDRUG

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Diagnosis of COPD and matching the following criteria: * Baseline 20 % \< FEV1 \< 70 % of European Community of Coal and Steel (ECCS) predicted values . * Baseline FEV1/SVC\< 70 %. Smoking history \> 10 pack-years (p.y.). A p.y. was defined as the equivalent of smoking one pack of cigarettes per day for one year.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (27)

Boehringer Ingelheim Investigational Site

Aix-les-Bains, 73100, France

Location

Hôpital Privé Antony

Antony, 92166, France

Location

Boehringer Ingelheim Investigational Site

Bordeaux, 33100, France

Location

Boehringer Ingelheim Investigational Site

Cambo-les-Bains, 64250, France

Location

Centre Médical Annie Enia

Cambo-les-Bains, 64250, France

Location

Boehringer Ingelheim Investigational Site

Châlons Sur Saône, 71100, France

Location

Hôpital Gabriel Montpied

Clermont-Ferrand, 63003, France

Location

Boehringer Ingelheim Investigational Site

Colmar, 68000, France

Location

CH Laennec

Creil, 60109, France

Location

Boehringer Ingelheim Investigational Site

Dole, 39100, France

Location

Centre Hospitalier

Longjumeau, 91160, France

Location

Boehringer Ingelheim Investigational Site

Lunéville, 54300, France

Location

MAPI CRO

Lyon, 69003, France

Location

Boehringer Ingelheim Investigational Site

Maxéville, 54320, France

Location

Boehringer Ingelheim Investigational Site

Metz, 57000, France

Location

Hôpital Notre Dame de Bon Secours

Metz, 57038, France

Location

Boehringer Ingelheim Investigational Site

Montigny-lès-Metz, 57950, France

Location

Boehringer Ingelheim Investigational Site

Mulhouse, 68100, France

Location

Hôpital Pitié Salpétrière

Paris, 75013, France

Location

Hôpital Cochin

Paris, 75679, France

Location

Boehringer Ingelheim Investigational Site

Poitiers, 86000, France

Location

Hôpital Saint Charles

Saint-Dié, 88187, France

Location

Groupe Hospitalier Sud Réunion

Saint-Pierre, 97448, France

Location

Boehringer Ingelheim Investigational Site

Saint-Quentin, 02100, France

Location

CH Toul

Toul, 54201, France

Location

Boehringer Ingelheim Investigational Site

Toulouse, 31300, France

Location

Boehringer Ingelheim Investigational Site

Vandœuvre-lès-Nancy, 54500, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Tiotropium Bromide

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-Ring

Study Officials

  • Boehringer Ingelheim Study Coordinator

    BI France S.A.S.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 9, 2006

First Posted

January 10, 2006

Study Start

April 1, 2002

Primary Completion

April 1, 2004

Study Completion

April 1, 2004

Last Updated

November 1, 2013

Record last verified: 2013-10

Locations

FR(27)