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Tiotropium / Respimat One-Year Study

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Tiotropium Inhalation Solution

Placebo

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Arm Label

Tiotropium Respimat 5mcg (Tio R5)

Tiotropium Respimat 10mcg (Tio R10)

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in Trough FEV1 at Week 48, Full Analysis Set - Clinic Spirometry (FAS-PFT)

Trough Forced Expiratory Volume in 1 second (FEV1)

Saint George's Respiratory Questionnaire (SGRQ) Total Score, Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL)

Rating scale of 3 domains - symptoms, activities and impact (weighted). Worst score = 100, best score = 0

TDI Focal Score, Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI) (Combined Studies)

Rating scale of 3 components - change in functional impairment, change in magnitude of tasks, change in magnitude of efforts. Worst score = -9, best score = +9 For this endpoint data of twin studies NCT00168844 and NCT00168831 was combined.

COPD Exacerbation Rate, Safety Set (SS) (Combined Studies)

Number of Chronic Obstructive Pulmonary Disease (COPD) exacerbations per patient year. For this endpoint data of the twin studies NCT00168844 and NCT00168831 was combined.

Secondary Outcome Measures

Change From Baseline in Heart Rate

Week 40 pre-dose - baseline

Change From Baseline in PR Interval

Change From Baseline in QRS Interval

Week 40 pre-dose - baseline

Change From Baseline in QT Interval

Week 40 pre-dose - baseline

Change From Baseline in QT Interval (Bazett)

Week 40 pre-dose - baseline

Change From Baseline in QT Interval (Fridericia)

Week 40 pre-dose - baseline

Change From Baseline in Heart Rate

Week 40 - baseline

Change From Baseline in Supraventricular Premature Beat (SVPB) Total

Week 40 - baseline

Holter (24-hour Period) - SVPB (Supraventricular Premature Beat) Run Events Change From Baseline in Supraventricular Premature Beat (SVPB) Run Events

Week 40 - baseline

Change From Baseline in SVPB Pairs

Week 40 - baseline

Change From Baseline in Ventricular Premature Beat (VPB) Total

Week 40 - baseline

Change From Baseline in VPB Run Events

Week 40 - baseline

Change From Baseline in VPB Pairs

Week 40 - baseline

Change From Baseline in Haematocrit, Packed Cell Volume (PCV)

Volume of red cells (erythrocytes) in blood, expressed as a fraction (percentage) of the total volume of blood

Change From Baseline in Haemoglobin

Week 48 - baseline

Change From Baseline in Red Blood Cell Count

Week 48 - baseline

Change From Baseline in White Blood Cell Count

Week 48 - baseline

Change From Baseline in Platelets

Week 48 - baseline

Change From Baseline in Neutrophils

Week 48 - baseline

Change From Baseline in Eosinophils

Week 48 - baseline

Change From Baseline in Basophils

Week 48 - baseline

Change From Baseline in Lymphocytes

Week 48 - baseline

Change From Baseline in Monocytes

Week 48 - baseline

Change From Baseline in Neutrophils (Absolute)

Week 48 - baseline

Change From Baseline in Lymphocytes (Absolute)

Week 48 - baseline

Change From Baseline in Eosinophils (Absolute)

Week 48 - baseline

Change From Baseline in Basophils (Absolute)

Week 48 - baseline

Change From Baseline in Monocytes (Absolute)

Week 48 - baseline

Change From Baseline in Calcium

Week 48 - baseline

Change From Baseline in Phosphate

Week 48 - baseline

Change From Baseline in Aspartate Transaminase (AST)/Glutamic-Oxaloacetic Transaminase (GOT), Serum GOT (SGOT)

Week 48 - baseline

Change From Baseline in Alanine Transaminase (ALT)/Glutamic Pyruvic Transaminase (GPT), Serum GPT (SGPT)

Week 48 - baseline

Change From Baseline in Alkaline Phosphatase

Week 48 - baseline

Change From Baseline in Lactic Dehydrogenase (LDH)

Week 48 - baseline

Change From Baseline in Glucose

Week 48 - baseline

Change From Baseline in Urea

Week 48 - baseline

Change From Baseline in Blood Urea Nitrogen

Week 48 - baseline

Change From Baseline in Creatinine

Week 48 - baseline

Change From Baseline in Bilirubin, Total

Week 48 - baseline

Change From Baseline in Uric Acid

Week 48 - baseline

Change From Baseline in Protein, Total

Week 48 - baseline

Change From Baseline in Albumin

Week 48 - baseline

Change From Baseline in Trough FEV1 After 2, 8, 16, 24, 32 and 40 Weeks

Change From Baseline in Trough Forced Expiratory Volume in 1 second (FEV1) after 2, 8, 16, 24, 32 and 40 weeks. The means are adjusted for centre, smoking status at entry and baseline value.

Change From Baseline in Trough FVC After 2, 8, 16, 24, 32, 40 and 48 Weeks

Change From Baseline in Trough Forced vital capacity (FVC) after 2, 8, 16, 24, 32, 40 and 48 weeks. The means are adjusted for centre, smoking status at entry and baseline value.

Change From Baseline in FEV1 AUC0-3 After 2, 8, 16, 24, 32, 40 and 48 Weeks

FEV1 AUC0-3 represents the Area under Curve over the time interval from 0 to 3 hours after 2, 8, 16, 24, 32, 40 and 48 weeks. The means are adjusted for centre, smoking status at entry and baseline value.

Change From Baseline in FVC AUC0-3 After 2, 8, 16, 24, 32, 40 and 48 Weeks

FVC AUC0-3 represents the Area under Curve over the time interval from 0 to 3 hours after 2, 8, 16, 24, 32, 40 and 48 weeks. The means are adjusted for centre, smoking status at entry and baseline value.

Weekly Mean Morning Pre-dose PEFRs

Weekly mean morning pre-dose peak expiratory flow rates (PEFRs). The means are adjusted for centre, smoking status at entry, and baseline value.

Weekly Mean Evening PEFRs

Weekly mean evening peak expiratory flow rates (PEFRs). The means are adjusted for centre, smoking status at entry, and baseline value.

Weekly Mean Number of Puffs of Rescue Medication Per Day

Weekly mean number of puffs of rescue medication used per day as required (PRN salbutamol). The means are adjusted for centre, smoking status at entry, and baseline value.

Mahler TDI Scores

Mahler Transitional Dyspnoea Index (TDI) scores measured as change in functional impairment, change in magnitude of tasks and change in magnitude of efforts over the treatment period. The means are adjusted for centre, smoking status at entry and baseline value. Worst score = -3, best score = +3

Saint George's Respiratory Questionnaire (SGRQ) Scores

Saint George's Respiratory Questionnaire (SGRQ) Scores impacts, activities and symptoms. Worst score = 100, best score = 0. The means are adjusted for centre, smoking status at entry and baseline value.

COPD Symptoms Scores

COPD symptoms Scores - wheezing, shortness of breath, coughing and tightness of chest over the treatment period. Scale: 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe The means are adjusted for centre, smoking status at entry and baseline value.

PGE Scores

Physician's Global evaluation (PGE) scores over the treatment period. Scale: 1-2 = Poor, 3-4 = Fair, 5-6 = Good, 7-8 = Excellent The means are adjusted for centre, smoking status at entry and baseline value.

PGR Score

Patient's Global rating (PGR) score over the treatment period. Scale: 1=much better to 7=much worse The means are adjusted for centre, smoking status at entry and baseline value.

Full Information

NCT ID

NCT00168844

First Posted

September 12, 2005

Last Updated

May 15, 2014

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT00168844

Brief Title

Tiotropium / Respimat One-Year Study

Official Title

A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Comparison of One-Year Treatment of Two Doses (5mg and 10mg) of Tiotropium Inhalation Solution Delivered by the Respimat Device in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Study Type

Interventional

2. Study Status

Record Verification Date

September 2013

Overall Recruitment Status

Completed

Study Start Date

January 2003 (undefined)

Primary Completion Date

June 2005 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary

To evaluate the long term effects of treatment with two doses of Tiotropium delivered by the Respimat inhaler in patients with COPD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pulmonary Disease, Chronic Obstructive

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Double

Allocation

Randomized

Enrollment

983 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tiotropium Respimat 5mcg (Tio R5)

Arm Type

Other

Arm Title

Tiotropium Respimat 10mcg (Tio R10)

Arm Type

Other

Arm Title

Placebo

Arm Type

Other

Intervention Type

Drug

Intervention Name(s)

Tiotropium Inhalation Solution

Intervention Type

Other

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Change From Baseline in Trough FEV1 at Week 48, Full Analysis Set - Clinic Spirometry (FAS-PFT)

Description

Trough Forced Expiratory Volume in 1 second (FEV1)

Time Frame

10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication

Title

Saint George's Respiratory Questionnaire (SGRQ) Total Score, Full Analysis Set - Saint George's Respiratory Questionnaire (FAS-QOL)

Description

Rating scale of 3 domains - symptoms, activities and impact (weighted). Worst score = 100, best score = 0

Time Frame

Week 48

Title

TDI Focal Score, Full Analysis Set - Transitional Dyspnoea Index (FAS-TDI) (Combined Studies)

Description

Time Frame

Week 48

Title

COPD Exacerbation Rate, Safety Set (SS) (Combined Studies)

Description

Number of Chronic Obstructive Pulmonary Disease (COPD) exacerbations per patient year. For this endpoint data of the twin studies NCT00168844 and NCT00168831 was combined.

Time Frame

48 weeks

Secondary Outcome Measure Information:

Title

Change From Baseline in Heart Rate

Description

Week 40 pre-dose - baseline

Time Frame

Baseline to Week 40 pre-dose

Title

Change From Baseline in PR Interval

Time Frame

Baseline to Week 40 pre-dose

Title

Change From Baseline in QRS Interval

Description

Week 40 pre-dose - baseline

Time Frame

Baseline to Week 40 pre-dose

Title

Change From Baseline in QT Interval

Description

Week 40 pre-dose - baseline

Time Frame

Baseline to Week 40 pre-dose

Title

Change From Baseline in QT Interval (Bazett)

Description

Week 40 pre-dose - baseline

Time Frame

Baseline to Week 40 pre-dose

Title

Change From Baseline in QT Interval (Fridericia)

Description

Week 40 pre-dose - baseline

Time Frame

Baseline to Week 40 pre-dose

Title

Change From Baseline in Heart Rate

Description

Week 40 - baseline

Time Frame

Baseline to Week 40

Title

Change From Baseline in Supraventricular Premature Beat (SVPB) Total

Description

Week 40 - baseline

Time Frame

Baseline to Week 40

Title

Holter (24-hour Period) - SVPB (Supraventricular Premature Beat) Run Events Change From Baseline in Supraventricular Premature Beat (SVPB) Run Events

Description

Week 40 - baseline

Time Frame

Baseline to Week 40

Title

Change From Baseline in SVPB Pairs

Description

Week 40 - baseline

Time Frame

Baseline to Week 40

Title

Change From Baseline in Ventricular Premature Beat (VPB) Total

Description

Week 40 - baseline

Time Frame

Baseline to Week 40

Title

Change From Baseline in VPB Run Events

Description

Week 40 - baseline

Time Frame

Baseline to Week 40

Title

Change From Baseline in VPB Pairs

Description

Week 40 - baseline

Time Frame

Baseline to Week 40

Title

Change From Baseline in Haematocrit, Packed Cell Volume (PCV)

Description

Volume of red cells (erythrocytes) in blood, expressed as a fraction (percentage) of the total volume of blood

Time Frame

Baseline to Week 48 or at premature discontinuation if before Week 48

Title

Change From Baseline in Haemoglobin

Description

Week 48 - baseline

Time Frame

Baseline to Week 48 or at premature discontinuation if before Week 48

Title

Change From Baseline in Red Blood Cell Count

Description

Week 48 - baseline

Time Frame

Baseline to Week 48 or at premature discontinuation if before Week 48

Title

Change From Baseline in White Blood Cell Count

Description

Week 48 - baseline

Time Frame

Baseline to Week 48 or at premature discontinuation if before Week 48

Title

Change From Baseline in Platelets

Description

Week 48 - baseline

Time Frame

Baseline to Week 48 or at premature discontinuation if before Week 48

Title

Change From Baseline in Neutrophils

Description

Week 48 - baseline

Time Frame

Baseline to Week 48 or at premature discontinuation if before Week 48

Title

Change From Baseline in Eosinophils

Description

Week 48 - baseline

Time Frame

Baseline to Week 48 or at premature discontinuation if before Week 48

Title

Change From Baseline in Basophils

Description

Week 48 - baseline

Time Frame

Baseline to Week 48 or at premature discontinuation if before Week 48

Title

Change From Baseline in Lymphocytes

Description

Week 48 - baseline

Time Frame

Baseline to Week 48 or at premature discontinuation if before Week 48

Title

Change From Baseline in Monocytes

Description

Week 48 - baseline

Time Frame

Baseline to Week 48 or at premature discontinuation if before Week 48

Title

Change From Baseline in Neutrophils (Absolute)

Description

Week 48 - baseline

Time Frame

Baseline to Week 48 or at premature discontinuation if before Week 48

Title

Change From Baseline in Lymphocytes (Absolute)

Description

Week 48 - baseline

Time Frame

Baseline to Week 48 or at premature discontinuation if before Week 48

Title

Change From Baseline in Eosinophils (Absolute)

Description

Week 48 - baseline

Time Frame

Baseline to Week 48 or at premature discontinuation if before Week 48

Title

Change From Baseline in Basophils (Absolute)

Description

Week 48 - baseline

Time Frame

Baseline to Week 48 or at premature discontinuation if before Week 48

Title

Change From Baseline in Monocytes (Absolute)

Description

Week 48 - baseline

Time Frame

Baseline to Week 48 or at premature discontinuation if before Week 48

Title

Change From Baseline in Calcium

Description

Week 48 - baseline

Time Frame

Baseline to Week 48 or at premature discontinuation if before Week 48

Title

Change From Baseline in Phosphate

Description

Week 48 - baseline

Time Frame

Baseline to Week 48 or at premature discontinuation if before Week 48

Title

Change From Baseline in Aspartate Transaminase (AST)/Glutamic-Oxaloacetic Transaminase (GOT), Serum GOT (SGOT)

Description

Week 48 - baseline

Time Frame

Baseline to Week 48 or at premature discontinuation if before Week 48

Title

Change From Baseline in Alanine Transaminase (ALT)/Glutamic Pyruvic Transaminase (GPT), Serum GPT (SGPT)

Description

Week 48 - baseline

Time Frame

Baseline to Week 48 or at premature discontinuation if before Week 48

Title

Change From Baseline in Alkaline Phosphatase

Description

Week 48 - baseline

Time Frame

Baseline to Week 48 or at premature discontinuation if before Week 48

Title

Change From Baseline in Lactic Dehydrogenase (LDH)

Description

Week 48 - baseline

Time Frame

Baseline to Week 48 or at premature discontinuation if before Week 48

Title

Change From Baseline in Glucose

Description

Week 48 - baseline

Time Frame

Baseline to Week 48 or at premature discontinuation if before Week 48

Title

Change From Baseline in Urea

Description

Week 48 - baseline

Time Frame

Baseline to Week 48 or at premature discontinuation if before Week 48

Title

Change From Baseline in Blood Urea Nitrogen

Description

Week 48 - baseline

Time Frame

Baseline to Week 48 or at premature discontinuation if before Week 48

Title

Change From Baseline in Creatinine

Description

Week 48 - baseline

Time Frame

Baseline to Week 48 or at premature discontinuation if before Week 48

Title

Change From Baseline in Bilirubin, Total

Description

Week 48 - baseline

Time Frame

Baseline to Week 48 or at premature discontinuation if before Week 48

Title

Change From Baseline in Uric Acid

Description

Week 48 - baseline

Time Frame

Baseline to Week 48 or at premature discontinuation if before Week 48

Title

Change From Baseline in Protein, Total

Description

Week 48 - baseline

Time Frame

Baseline to Week 48 or at premature discontinuation if before Week 48

Title

Change From Baseline in Albumin

Description

Week 48 - baseline

Time Frame

Baseline to Week 48 or at premature discontinuation if before Week 48

Title

Change From Baseline in Trough FEV1 After 2, 8, 16, 24, 32 and 40 Weeks

Description

Change From Baseline in Trough Forced Expiratory Volume in 1 second (FEV1) after 2, 8, 16, 24, 32 and 40 weeks. The means are adjusted for centre, smoking status at entry and baseline value.

Time Frame

10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication

Title

Change From Baseline in Trough FVC After 2, 8, 16, 24, 32, 40 and 48 Weeks

Description

Change From Baseline in Trough Forced vital capacity (FVC) after 2, 8, 16, 24, 32, 40 and 48 weeks. The means are adjusted for centre, smoking status at entry and baseline value.

Time Frame

10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication

Title

Change From Baseline in FEV1 AUC0-3 After 2, 8, 16, 24, 32, 40 and 48 Weeks

Description

Time Frame

10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication

Title

Change From Baseline in FVC AUC0-3 After 2, 8, 16, 24, 32, 40 and 48 Weeks

Description

Time Frame

10 minutes prior to test-drug inhalation and at 5, 30 and 60 minutes and 2 and 3 hours after inhalation of study medication

Title

Weekly Mean Morning Pre-dose PEFRs

Description

Weekly mean morning pre-dose peak expiratory flow rates (PEFRs). The means are adjusted for centre, smoking status at entry, and baseline value.

Time Frame

Weeks 2, 8, 16, 24, 32, 40, 48

Title

Weekly Mean Evening PEFRs

Description

Weekly mean evening peak expiratory flow rates (PEFRs). The means are adjusted for centre, smoking status at entry, and baseline value.

Time Frame

Weeks 2, 8, 16, 24, 32, 40, 48

Title

Weekly Mean Number of Puffs of Rescue Medication Per Day

Description

Weekly mean number of puffs of rescue medication used per day as required (PRN salbutamol). The means are adjusted for centre, smoking status at entry, and baseline value.

Time Frame

Weeks 2, 8, 16, 24, 32, 40, 48

Title

Mahler TDI Scores

Description

Time Frame

Week 48

Title

Saint George's Respiratory Questionnaire (SGRQ) Scores

Description

Time Frame

Week 48

Title

COPD Symptoms Scores

Description

Time Frame

Week 48

Title

PGE Scores

Description

Time Frame

Week 48

Title

PGR Score

Description

Patient's Global rating (PGR) score over the treatment period. Scale: 1=much better to 7=much worse The means are adjusted for centre, smoking status at entry and baseline value.

Time Frame

Week 48

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Boehringer Ingelheim Study Coordinator

Organizational Affiliation

Boehringer Ingelheim

Official's Role

Study Chair

Facility Information:

Facility Name

Boehringer Ingelheim Investigational Site

City

Los Angeles

State/Province

California

Country

United States

Facility Name

Boehringer Ingelheim Investigational Site

City

Pismo Beach

State/Province

California

Country

United States

Facility Name

Boehringer Ingelheim Investigational Site

City

San Diego

State/Province

California

Country

United States

Facility Name

Boehringer Ingelheim Investigational Site

City

Fort Collins

State/Province

Colorado

Country

United States

Facility Name

Boehringer Ingelheim Investigational Site

City

Minneapolis

State/Province

Minnesota

Country

United States

Facility Name

Boehringer Ingelheim Investigational Site

City

Larchmont

State/Province

New York

Country

United States

Facility Name

Boehringer Ingelheim Investigational Site

City

Raleigh

State/Province

North Carolina

Country

United States

Facility Name

Boehringer Ingelheim Investigational Site

City

Chattanooga

State/Province

Tennessee

Country

United States

Facility Name

Boehringer Ingelheim Investigational Site

City

Harker Heights

State/Province

Texas

Country

United States

Facility Name

Boehringer Ingelheim Investigational Site

City

Houston

State/Province

Texas

Country

United States

Facility Name

Boehringer Ingelheim Investigational Site

City

Fredericksburg

State/Province

Virginia

Country

United States

Facility Name

Boehringer Ingelheim Investigational Site

City

Harrisonburg

State/Province

Virginia

Country

United States

Facility Name

Boehringer Ingelheim Investigational Site

City

Toorak Gardens

State/Province

South Australia

Country

Australia

Facility Name

Boehringer Ingelheim Investigational Site

City

Woodville

State/Province

South Australia

Country

Australia

Facility Name

Boehringer Ingelheim Investigational Site

City

Clayton

State/Province

Victoria

Country

Australia

Facility Name

Boehringer Ingelheim Investigational Site

City

Frankston

State/Province

Victoria

Country

Australia

Facility Name

Boehringer Ingelheim Investigational Site

City

Perth

State/Province

Western Australia

Country

Australia

Facility Name

Boehringer Ingelheim Investigational Site

City

Antwerpen

Country

Belgium

Facility Name

Boehringer Ingelheim Investigational Site

City

Brussel

Country

Belgium

Facility Name

Boehringer Ingelheim Investigational Site

City

Bruxelles

Country

Belgium

Facility Name

Boehringer Ingelheim Investigational Site

City

Genk

Country

Belgium

Facility Name

Boehringer Ingelheim Investigational Site

City

Gent

Country

Belgium

Facility Name

Boehringer Ingelheim Investigational Site

City

Liège

Country

Belgium

Facility Name

Boehringer Ingelheim Investigational Site

City

Wavre

Country

Belgium

Facility Name

Boehringer Ingelheim Investigational Site

City

Edmonton

State/Province

Alberta

Country

Canada

Facility Name

Boehringer Ingelheim Investigational Site

City

Halifax

State/Province

Nova Scotia

Country

Canada

Facility Name

Boehringer Ingelheim Investigational Site

City

Courtice

State/Province

Ontario

Country

Canada

Facility Name

Boehringer Ingelheim Investigational Site

City

Mississauga

State/Province

Ontario

Country

Canada

Facility Name

Boehringer Ingelheim Investigational Site

City

Ottawa

State/Province

Ontario

Country

Canada

Facility Name

Boehringer Ingelheim Investigational Site

City

Toronto

State/Province

Ontario

Country

Canada

Facility Name

Boehringer Ingelheim Investigational Site

City

Sainte-Foy

State/Province

Quebec

Country

Canada

Facility Name

Boehringer Ingelheim Investigational Site

City

Angers

Country

France

Facility Name

Boehringer Ingelheim Investigational Site

City

Beuvry

Country

France

Facility Name

Boehringer Ingelheim Investigational Site

City

Cambrai

Country

France

Facility Name

Boehringer Ingelheim Investigational Site

City

Lille

Country

France

Facility Name

Boehringer Ingelheim Investigational Site

City

Metz cedex 01

Country

France

Facility Name

Boehringer Ingelheim Investigational Site

City

Berlin

Country

Germany

Facility Name

Boehringer Ingelheim Investigational Site

City

Darmstadt

Country

Germany

Facility Name

Boehringer Ingelheim Investigational Site

City

Gelnhausen

Country

Germany

Facility Name

Boehringer Ingelheim Investigational Site

City

Kassel

Country

Germany

Facility Name

Boehringer Ingelheim Investigational Site

City

Rüdersdorf

Country

Germany

Facility Name

Boehringer Ingelheim Investigational Site

City

Athens

Country

Greece

Facility Name

Boehringer Ingelheim Investigational Site

City

Heraklion

Country

Greece

Facility Name

Boehringer Ingelheim Investigational Site

City

Larissa

Country

Greece

Facility Name

Boehringer Ingelheim Investigational Site

City

Maroussi, Athens

Country

Greece

Facility Name

Boehringer Ingelheim Investigational Site

City

Melissia-Athens

Country

Greece

Facility Name

Boehringer Ingelheim Investigational Site

City

Breda

Country

Netherlands

Facility Name

Boehringer Ingelheim Investigational Site

City

Dordrecht

Country

Netherlands

Facility Name

Boehringer Ingelheim Investigational Site

City

Groningen

Country

Netherlands

Facility Name

Boehringer Ingelheim Investigational Site

City

Harderwijk

Country

Netherlands

Facility Name

Boehringer Ingelheim Investigational Site

City

Heerlen

Country

Netherlands

Facility Name

Boehringer Ingelheim Investigational Site

City

Zutphen

Country

Netherlands

Facility Name

Boehringer Ingelheim Investigational Site

City

Oslo

Country

Norway

Facility Name

Boehringer Ingelheim Investigational Site

City

Trondheim

Country

Norway

Facility Name

Boehringer Ingelheim Investigational Site

City

Ålesund

Country

Norway

Facility Name

Boehringer Ingelheim Investigational Site

City

Moscow

Country

Russian Federation

Facility Name

Boehringer Ingelheim Investigational Site

City

Alicante

Country

Spain

Facility Name

Boehringer Ingelheim Investigational Site

City

Las Palmas de Gran Canaria

Country

Spain

Facility Name

Boehringer Ingelheim Investigational Site

City

Madrid

Country

Spain

Facility Name

Boehringer Ingelheim Investigational Site

City

Vic (Barcelona)

Country

Spain

Facility Name

Boehringer Ingelheim Investigational Site

City

Motala

Country

Sweden

Facility Name

Boehringer Ingelheim Investigational Site

City

Skövde

Country

Sweden

Facility Name

Boehringer Ingelheim Investigational Site

City

Uppsala

Country

Sweden

Facility Name

Boehringer Ingelheim Investigational Site

City

Varberg

Country

Sweden

Facility Name

Boehringer Ingelheim Investigational Site

City

Ankara

Country

Turkey

Facility Name

Boehringer Ingelheim Investigational Site

City

Bursa

Country

Turkey

Facility Name

Boehringer Ingelheim Investigational Site

City

Istanbul

Country

Turkey

Facility Name

Boehringer Ingelheim Investigational Site

City

Birmingham

Country

United Kingdom

Facility Name

Boehringer Ingelheim Investigational Site

City

Bristol

Country

United Kingdom

Facility Name

Boehringer Ingelheim Investigational Site

City

Nottingham

Country

United Kingdom

Facility Name

Boehringer Ingelheim Investigational Site

City

Sheffield

Country

United Kingdom

Facility Name

Boehringer Ingelheim Investigational Site

City

Swansea

Country

United Kingdom

Facility Name

Boehringer Ingelheim Investigational Site

City

Torquay

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

32943047

Citation

Singh D, Wedzicha JA, Siddiqui S, de la Hoz A, Xue W, Magnussen H, Miravitlles M, Chalmers JD, Calverley PMA. Blood eosinophils as a biomarker of future COPD exacerbation risk: pooled data from 11 clinical trials. Respir Res. 2020 Sep 17;21(1):240. doi: 10.1186/s12931-020-01482-1.

Results Reference

derived

PubMed Identifier

25496316

Citation

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.

Results Reference

derived

PubMed Identifier

21814460

Citation

Hodder R, Pavia D, Lee A, Bateman E. Lack of paradoxical bronchoconstriction after administration of tiotropium via Respimat(R) Soft Mist Inhaler in COPD. Int J Chron Obstruct Pulmon Dis. 2011;6:245-51. doi: 10.2147/COPD.S16094. Epub 2011 Apr 26.

Results Reference

derived

Links:

URL

http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.254_U05-2112-DS.pdf

Description

Related Info

URL

http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/Pooled%20analysis/PA_205.372_251_252_254_255_U10-3255-01.pdf

Description

Related Info

URL

http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.254_literature.pdf

Description

Related Info

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Tiotropium / Respimat One-Year Study

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Tiotropium / Respimat One-Year Study

Pulmonary Disease, Chronic Obstructive

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

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