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TERMINATED
NCT00668772
PHASE3

Tiotropium/Salmeterol Inhalation Powder in COPD

Sponsor: Boehringer Ingelheim

View on ClinicalTrials.gov

Summary

The primary objectives of this study are to assess bronchodilator efficacy as determined by forced expiratory volume in one second (FEV1), the effect on dyspnoea as determined by the Baseline Dyspnoea Index (BDI)/Transition Dyspnoea Index (TDI), the effect on health status as determined by the St George Respiratory Questionnaire (SGRQ) and the effect on chronic obstructive pulmonary disease (COPD) exacerbations

Official title: A 24-week (+ 24 Week Extension) Placebo-controlled (Only 1st 12-week Period), Double-Blind, Parallel-group, Efficacy and Safety Comparison of Fixed-dose Combination (FDC) Tiotropium/Salmeterol, Tiotropium, Salmeterol and FDC Tiotropium/Salmeterol Plus Salmeterol in Chronic Obstructive Pulmonary Disease (COPD) Patients

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

207

Start Date

2008-04-15

Completion Date

2008-11-21

Last Updated

2026-07-16

Healthy Volunteers

No

Interventions

DRUG

Tiotropium/Salmeterol

Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene (PE) Capsule

DRUG

Salmeterol

Salmeterol Inhalation Powder, hard PE capsule

DRUG

Placebo

Placebo Inhalation Powder, hard PE capsule / hard gelatine capsule

DRUG

Tiotropium

Tiotropium Inhalation Powder, hard gelatine capsule (Spiriva®)

Locations (64)

1184.15.01069 Boehringer Ingelheim Investigational Site

Anniston, Alabama, United States

1184.15.01071 Boehringer Ingelheim Investigational Site

Mobile, Alabama, United States

1184.15.01054 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

1184.15.01063 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

1184.15.01064 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

1184.15.01065 Boehringer Ingelheim Investigational Site

Savannah, Georgia, United States

1184.15.01052 Boehringer Ingelheim Investigational Site

New Orleans, Louisiana, United States

1184.15.01055 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

1184.15.01058 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

1184.15.01062 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

1184.15.01072 Boehringer Ingelheim Investigational Site

Summit, New Jersey, United States

1184.15.01053 Boehringer Ingelheim Investigational Site

Albuquerque, New Mexico, United States

1184.15.01070 Boehringer Ingelheim Investigational Site

New York, New York, United States

1184.15.01057 Boehringer Ingelheim Investigational Site

Elizabeth City, North Carolina, United States

1184.15.01059 Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

1184.15.01051 Boehringer Ingelheim Investigational Site

Morgantown, West Virginia, United States

1184.15.43052 Boehringer Ingelheim Investigational Site

Gänserndorf, Austria

1184.15.43053 Boehringer Ingelheim Investigational Site

Vienna, Austria

1184.15.02057 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

1184.15.02059 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

1184.15.02055 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

1184.15.02058 Boehringer Ingelheim Investigational Site

Ottawa, Ontario, Canada

1184.15.02051 Boehringer Ingelheim Investigational Site

Scarborough Village, Ontario, Canada

1184.15.02053 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

1184.15.02060 Boehringer Ingelheim Investigational Site

Longueuil, Quebec, Canada

1184.15.02056 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

1184.15.45054 Boehringer Ingelheim Investigational Site

Aalborg, Denmark

1184.15.45052 Boehringer Ingelheim Investigational Site

Kolding, Denmark

1184.15.45051 Boehringer Ingelheim Investigational Site

Odense C, Denmark

1184.15.45053 Boehringer Ingelheim Investigational Site

Silkeborg, Denmark

1184.15.37252 Boehringer Ingelheim Investigational Site

Kohtla-Järve, Estonia

1184.15.37251 Boehringer Ingelheim Investigational Site

Tallinn, Estonia

1184.15.35852 Boehringer Ingelheim Investigational Site

Oulu, Finland

1184.15.35851 Boehringer Ingelheim Investigational Site

Tampere, Finland

1184.15.3350A Boehringer Ingelheim Investigational Site

Marseille, France

1184.15.3351A Boehringer Ingelheim Investigational Site

Nantes, France

1184.15.3352A Boehringer Ingelheim Investigational Site

Paris, France

1184.15.49056 Boehringer Ingelheim Investigational Site

Aschaffenburg, Germany

1184.15.49053 Boehringer Ingelheim Investigational Site

Frankfurt, Germany

1184.15.49057 Boehringer Ingelheim Investigational Site

Gelnhausen, Germany

1184.15.49052 Boehringer Ingelheim Investigational Site

Hanover, Germany

1184.15.49058 Boehringer Ingelheim Investigational Site

Hanover, Germany

1184.15.36055 Boehringer Ingelheim Investigational Site

Deszk, Hungary

1184.15.36053 Boehringer Ingelheim Investigational Site

Érd, Hungary

1184.15.36054 Boehringer Ingelheim Investigational Site

Szarvas, Hungary

1184.15.36052 Boehringer Ingelheim Investigational Site

Szeged, Hungary

1184.15.39051 Boehringer Ingelheim Investigational Site

Florence, Italy

1184.15.37154 Boehringer Ingelheim Investigational Site

Balvi, Latvia

1184.15.37152 Boehringer Ingelheim Investigational Site

Jelgava, Latvia

1184.15.37153 Boehringer Ingelheim Investigational Site

Tukums, Latvia

1184.15.37053 Boehringer Ingelheim Investigational Site

Klaipėda, Lithuania

1184.15.31051 Boehringer Ingelheim Investigational Site

Breda, Netherlands

1184.15.31054 Boehringer Ingelheim Investigational Site

Utrecht, Netherlands

1184.15.31052 Boehringer Ingelheim Investigational Site

Zutphen, Netherlands

1184.15.42153 Boehringer Ingelheim Investigational Site

Bratislava, Slovakia

1184.15.42154 Boehringer Ingelheim Investigational Site

Bratislava, Slovakia

1184.15.27051

Bellville, South Africa

1184.15.27052

Cape Town, South Africa

1184.15.27053

Somerset West, South Africa

1184.15.82051 Boehringer Ingelheim Investigational Site

Jeonju, South Korea

1184.15.82052 Boehringer Ingelheim Investigational Site

Suwon, South Korea

1184.15.82053 Boehringer Ingelheim Investigational Site

Wŏnju, South Korea

1184.15.46053 Boehringer Ingelheim Investigational Site

Boden, Sweden

1184.15.46051 Boehringer Ingelheim Investigational Site

Stockholm, Sweden