Back to results

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

Criteria Patients with stable moderate to severe COPD and a smoking history of at least 10 pack years were eligible for inclusion in the study. Patients with significant diseases other than COPD were excluded as were patients with a recent history of myocardial infarction, history of malignancy, unstable or life-threatening cardiac arrhythmia, narrow-angle glaucoma, asthma or other allergic conditions. Patients treated with cromolyn, nedocromil, oral beta-adrenergics or unstable doses of oral corticosteroids were ineligible for inclusion in the study as were patients who had received previous treatment with tiotropium.

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 After 48 Weeks

Change From Baseline in Trough Forced Expiratory Volume in 1 second (FEV1) after 48 weeks

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

Change From Baseline in 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 Ventricular Premature Beat (VPB) Run Events

Week 40 - baseline

Change From Baseline in VPB Pairs

Week 40 - baseline

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

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 Eosinophils (Absolute)

Week 48 - baseline

Change From Baseline in Basophils (Absolute)

Week 48 - baseline

Change From Baseline in Lymphocytes (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/Glutamic-oxaloacetic Transaminase (AST/GOT), Serum Glutamic-oxaloacetic Transaminase (SGOT)

Week 48 - baseline

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

Week 48 - baseline

Change From Baseline in Alkaline Phosphatase

Week 48 - baseline

Change From Baseline in Lactic Dehyrogenase (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 Morning 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 Scores

Patient's Global rating (PGR) scores 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

NCT00168831

First Posted

September 12, 2005

Last Updated

May 15, 2014

Sponsor

Boehringer Ingelheim

1. Study Identification

Unique Protocol Identification Number

NCT00168831

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

February 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

1007 (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 After 48 Weeks

Description

Change From Baseline in Trough Forced Expiratory Volume in 1 second (FEV1) after 48 weeks

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

Change From Baseline in 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 Ventricular Premature Beat (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)

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 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 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 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/Glutamic-oxaloacetic Transaminase (AST/GOT), Serum Glutamic-oxaloacetic Transaminase (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/Glutamic Pyruvate Transaminase (ALT/GPT), Serum Glutamate Pyruvate Transaminase (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 Dehyrogenase (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 Morning 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 Scores

Description

Patient's Global rating (PGR) scores 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

Eligibility Criteria

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

Birmingham

State/Province

Alabama

Country

United States

Facility Name

Boehringer Ingelheim Investigational Site

City

La Jolla

State/Province

California

Country

United States

Facility Name

Boehringer Ingelheim Investigational Site

City

Long Beach

State/Province

California

Country

United States

Facility Name

Boehringer Ingelheim Investigational Site

City

San Luis Obispo

State/Province

California

Country

United States

Facility Name

Boehringer Ingelheim Investigational Site

City

Gainesville

State/Province

Florida

Country

United States

Facility Name

Boehringer Ingelheim Investigational Site

City

Hallandale

State/Province

Florida

Country

United States

Facility Name

Boehringer Ingelheim Investigational Site

City

Hines

State/Province

Illinois

Country

United States

Facility Name

Boehringer Ingelheim Investigational Site

City

Chesterfield

State/Province

Missouri

Country

United States

Facility Name

Boehringer Ingelheim Investigational Site

City

Bay Shore

State/Province

New York

Country

United States

Facility Name

Boehringer Ingelheim Investigational Site

City

Charleston

State/Province

South Carolina

Country

United States

Facility Name

Boehringer Ingelheim Investigational Site

City

Houston

State/Province

Texas

Country

United States

Facility Name

Boehringer Ingelheim Investigational Site

City

Richmond

State/Province

Virginia

Country

United States

Facility Name

Boehringer Ingelheim Investigational Site

City

Garran

State/Province

Australian Capital Territory

Country

Australia

Facility Name

Boehringer Ingelheim Investigational Site

City

Adelaide

State/Province

South Australia

Country

Australia

Facility Name

Boehringer Ingelheim Investigational Site

City

Nedlands

State/Province

Western Australia

Country

Australia

Facility Name

Boehringer Ingelheim Investigational Site

City

Innsbruck

Country

Austria

Facility Name

Boehringer Ingelheim Investigational Site

City

Mittersill

Country

Austria

Facility Name

Boehringer Ingelheim Investigational Site

City

Schwechat

Country

Austria

Facility Name

Boehringer Ingelheim Investigational Site

City

Wels

Country

Austria

Facility Name

Baumgartner Hohe Otto Wagner Spital Wien

City

Wien

Country

Austria

Facility Name

Boehringer Ingelheim Investigational Site

City

Wien

Country

Austria

Facility Name

Boehringer Ingelheim Investigational Site

City

Winnipeg

State/Province

Manitoba

Country

Canada

Facility Name

Boehringer Ingelheim Investigational Site

City

Hamilton

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

Montreal

State/Province

Quebec

Country

Canada

Facility Name

Boehringer Ingelheim Investigational Site

City

Sherbrooke

State/Province

Quebec

Country

Canada

Facility Name

Boehringer Ingelheim Investigational Site

City

Espoo

Country

Finland

Facility Name

Boehringer Ingelheim Investigational Site

City

Helsinki

Country

Finland

Facility Name

Boehringer Ingelheim Investigational Site

City

Lahti

Country

Finland

Facility Name

Boehringer Ingelheim Investigational Site

City

Lappeenranta

Country

Finland

Facility Name

Boehringer Ingelheim Investigational Site

City

Lohja

Country

Finland

Facility Name

Boehringer Ingelheim Investigational Site

City

Amboise cedex

Country

France

Facility Name

Boehringer Ingelheim Investigational Site

City

Chauny

Country

France

Facility Name

Boehringer Ingelheim Investigational Site

City

Marseille cedex 06

Country

France

Facility Name

Boehringer Ingelheim Investigational Site

City

Metz cedex 01

Country

France

Facility Name

Boehringer Ingelheim Investigational Site

City

Montpellier

Country

France

Facility Name

Boehringer Ingelheim Investigational Site

City

Nantes

Country

France

Facility Name

Boehringer Ingelheim Investigational Site

City

Alexandroupolis

Country

Greece

Facility Name

Boehringer Ingelheim Investigational Site

City

Athens

Country

Greece

Facility Name

Boehringer Ingelheim Investigational Site

City

Mournies-Chania

Country

Greece

Facility Name

Boehringer Ingelheim Investigational Site

City

Trikala

Country

Greece

Facility Name

Boehringer Ingelheim Investigational Site

City

Dublin 4

Country

Ireland

Facility Name

Boehringer Ingelheim Investigational Site

City

Dublin 7

Country

Ireland

Facility Name

Boehringer Ingelheim Investigational Site

City

Dublin

Country

Ireland

Facility Name

Boehringer Ingelheim Investigational Site

City

Bologna

Country

Italy

Facility Name

Boehringer Ingelheim Investigational Site

City

Bussolengo (vr)

Country

Italy

Facility Name

Boehringer Ingelheim Investigational Site

City

Cava dei tirreni (SA)

Country

Italy

Facility Name

Boehringer Ingelheim Investigational Site

City

Crema (CR)

Country

Italy

Facility Name

Boehringer Ingelheim Investigational Site

City

Genova

Country

Italy

Facility Name

Boehringer Ingelheim Investigational Site

City

Milano

Country

Italy

Facility Name

Boehringer Ingelheim Investigational Site

City

Pistoia

Country

Italy

Facility Name

Boehringer Ingelheim Investigational Site

City

Roma

Country

Italy

Facility Name

Boehringer Ingelheim Investigational Site

City

Salerno

Country

Italy

Facility Name

Boehringer Ingelheim Investigational Site

City

Sesto San Giovanni (Milano)

Country

Italy

Facility Name

Boehringer Ingelheim Investigational Site

City

Arnhem

Country

Netherlands

Facility Name

Boehringer Ingelheim Investigational Site

City

Eindhoven

Country

Netherlands

Facility Name

Boehringer Ingelheim Investigational Site

City

Heerenveen

Country

Netherlands

Facility Name

Boehringer Ingelheim Investigational Site

City

Hoorn

Country

Netherlands

Facility Name

Boehringer Ingelheim Investigational Site

City

Leeuwarden

Country

Netherlands

Facility Name

Boehringer Ingelheim Investigational Site

City

Rotterdam

Country

Netherlands

Facility Name

Boehringer Ingelheim Investigational Site

City

Auckland

Country

New Zealand

Facility Name

Boehringer Ingelheim Investigational Site

City

Hamilton

Country

New Zealand

Facility Name

Boehringer Ingelheim Investigational Site

City

St. Petersburg

Country

Russian Federation

Facility Name

Boehringer Ingelheim Investigational Site

City

Bellville

Country

South Africa

Facility Name

Boehringer Ingelheim Investigational Site

City

Cape Town

Country

South Africa

Facility Name

Boehringer Ingelheim Investigational Site

City

George

Country

South Africa

Facility Name

Boehringer Ingelheim Investigational Site

City

Johannesburg

Country

South Africa

Facility Name

Boehringer Ingelheim Investigational Site

City

Vanderbijlpark

Country

South Africa

Facility Name

Boehringer Ingelheim Investigational Site

City

Barcelona

Country

Spain

Facility Name

Boehringer Ingelheim Investigational Site

City

Centelles

Country

Spain

Facility Name

Boehringer Ingelheim Investigational Site

City

Murcia

Country

Spain

Facility Name

Boehringer Ingelheim Investigational Site

City

Sant Boi de Llobregat (Barcelona)

Country

Spain

Facility Name

Boehringer Ingelheim Investigational Site

City

Babbacombe

Country

United Kingdom

Facility Name

Boehringer Ingelheim Investigational Site

City

Cottingham

Country

United Kingdom

Facility Name

Boehringer Ingelheim Investigational Site

City

Isleworth

Country

United Kingdom

Facility Name

Boehringer Ingelheim Investigational Site

City

Manchester

Country

United Kingdom

Facility Name

Boehringer Ingelheim Investigational Site

City

Plymouth

Country

United Kingdom

Facility Name

Boehringer Ingelheim Investigational Site

City

Sunderland

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/205/205.255_U05-2113-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/205/205.255_literature.pdf

Description

Related Info

Learn more about this trial

Tiotropium / Respimat One-Year Study

We'll reach out to this number within 24 hrs

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

Learn more about this trial