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Tiotropium/Salmeterol Inhalation Powder in COPD

NCT ID: NCT00668772

Last Updated: 2023-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

207 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-15

Study Completion Date

2008-11-21

Brief Summary

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The primary objectives of this study are to assess bronchodilator efficacy as determined by FEV1, the effect on dyspnoea as determined by the BDI/TDI, the effect on health status as determined bt the SGRQ and the effect on COPD exacerbations

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Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Tiotropium/Salmeterol QD

Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule

Group Type EXPERIMENTAL

Tiotropium/Salmeterol

Intervention Type DRUG

Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule

Tiotropium QD

Tiotropium Inhalation Powder, hard gelatine capsule (Spiriva®)

Group Type ACTIVE_COMPARATOR

Tiotropium

Intervention Type DRUG

Tiotropium Inhalation Powder, hard gelatine capsule (Spiriva®)

Salmeterol BID

Salmeterol Inhalation Powder, hard PE capsule

Group Type ACTIVE_COMPARATOR

Salmeterol

Intervention Type DRUG

Salmeterol Inhalation Powder, hard PE capsule

Tiotropium/Salmeterol QD + Salmeterol

Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule, plus Salmeterol Inhalation Powder, hard PE capsule

Group Type ACTIVE_COMPARATOR

Tiotropium/Salmeterol QD + Salmeterol

Intervention Type DRUG

Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule, plus Salmeterol Inhalation Powder, hard PE capsule

Placebo

Placebo Inhalation Powder, hard PE capsule / hard gelatine capsule

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo Inhalation Powder, hard PE capsule / hard gelatine capsule

Interventions

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Tiotropium/Salmeterol

Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule

Intervention Type DRUG

Tiotropium/Salmeterol QD + Salmeterol

Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule, plus Salmeterol Inhalation Powder, hard PE capsule

Intervention Type DRUG

Placebo

Placebo Inhalation Powder, hard PE capsule / hard gelatine capsule

Intervention Type DRUG

Salmeterol

Salmeterol Inhalation Powder, hard PE capsule

Intervention Type DRUG

Tiotropium

Tiotropium Inhalation Powder, hard gelatine capsule (Spiriva®)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Main:

Diagnosis of COPD Post-bronchodilator FEV1\<80% predicted and FEV1/FVC\<70% predicted

Exclusion Criteria

Main:

Significant other diseases then COPD Recent MI Any unstable or life-threatening cardiac arrythmia requiring intervention or change in drug therapy during the past year Hospitalisation for cardiac failure during the past year History of asthma
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Boehringer Ingelheim

Role: STUDY_CHAIR

Boehringer Ingelheim

Locations

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1184.15.01069 Boehringer Ingelheim Investigational Site

Anniston, Alabama, United States

Site Status

1184.15.01071 Boehringer Ingelheim Investigational Site

Mobile, Alabama, United States

Site Status

1184.15.01054 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

Site Status

1184.15.01063 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

Site Status

1184.15.01064 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

Site Status

1184.15.01065 Boehringer Ingelheim Investigational Site

Savannah, Georgia, United States

Site Status

1184.15.01052 Boehringer Ingelheim Investigational Site

New Orleans, Louisiana, United States

Site Status

1184.15.01055 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Site Status

1184.15.01058 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Site Status

1184.15.01062 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Site Status

1184.15.01072 Boehringer Ingelheim Investigational Site

Summit, New Jersey, United States

Site Status

1184.15.01053 Boehringer Ingelheim Investigational Site

Albuquerque, New Mexico, United States

Site Status

1184.15.01070 Boehringer Ingelheim Investigational Site

New York, New York, United States

Site Status

1184.15.01057 Boehringer Ingelheim Investigational Site

Elizabeth City, North Carolina, United States

Site Status

1184.15.01059 Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

Site Status

1184.15.01051 Boehringer Ingelheim Investigational Site

Morgantown, West Virginia, United States

Site Status

1184.15.43052 Boehringer Ingelheim Investigational Site

Gänserndorf, , Austria

Site Status

1184.15.43053 Boehringer Ingelheim Investigational Site

Vienna, , Austria

Site Status

1184.15.02057 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Site Status

1184.15.02059 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Site Status

1184.15.02055 Boehringer Ingelheim Investigational Site

Hamilton, Ontario, Canada

Site Status

1184.15.02058 Boehringer Ingelheim Investigational Site

Ottawa, Ontario, Canada

Site Status

1184.15.02051 Boehringer Ingelheim Investigational Site

Scarborough Village, Ontario, Canada

Site Status

1184.15.02053 Boehringer Ingelheim Investigational Site

Toronto, Ontario, Canada

Site Status

1184.15.02060 Boehringer Ingelheim Investigational Site

Longueuil, Quebec, Canada

Site Status

1184.15.02056 Boehringer Ingelheim Investigational Site

Montreal, Quebec, Canada

Site Status

1184.15.45054 Boehringer Ingelheim Investigational Site

Aalborg, , Denmark

Site Status

1184.15.45052 Boehringer Ingelheim Investigational Site

Kolding, , Denmark

Site Status

1184.15.45051 Boehringer Ingelheim Investigational Site

Odense C, , Denmark

Site Status

1184.15.45053 Boehringer Ingelheim Investigational Site

Silkeborg, , Denmark

Site Status

1184.15.37252 Boehringer Ingelheim Investigational Site

Kohtla-Järve, , Estonia

Site Status

1184.15.37251 Boehringer Ingelheim Investigational Site

Tallinn, , Estonia

Site Status

1184.15.35852 Boehringer Ingelheim Investigational Site

Oulu, , Finland

Site Status

1184.15.35851 Boehringer Ingelheim Investigational Site

Tampere, , Finland

Site Status

1184.15.3350A Boehringer Ingelheim Investigational Site

Marseille, , France

Site Status

1184.15.3351A Boehringer Ingelheim Investigational Site

Nantes, , France

Site Status

1184.15.3352A Boehringer Ingelheim Investigational Site

Paris, , France

Site Status

1184.15.49056 Boehringer Ingelheim Investigational Site

Aschaffenburg, , Germany

Site Status

1184.15.49053 Boehringer Ingelheim Investigational Site

Frankfurt, , Germany

Site Status

1184.15.49057 Boehringer Ingelheim Investigational Site

Gelnhausen, , Germany

Site Status

1184.15.49052 Boehringer Ingelheim Investigational Site

Hanover, , Germany

Site Status

1184.15.49058 Boehringer Ingelheim Investigational Site

Hanover, , Germany

Site Status

1184.15.36055 Boehringer Ingelheim Investigational Site

Deszk, , Hungary

Site Status

1184.15.36053 Boehringer Ingelheim Investigational Site

Érd, , Hungary

Site Status

1184.15.36054 Boehringer Ingelheim Investigational Site

Szarvas, , Hungary

Site Status

1184.15.36052 Boehringer Ingelheim Investigational Site

Szeged, , Hungary

Site Status

1184.15.39051 Boehringer Ingelheim Investigational Site

Florence, , Italy

Site Status

1184.15.37154 Boehringer Ingelheim Investigational Site

Balvi, , Latvia

Site Status

1184.15.37152 Boehringer Ingelheim Investigational Site

Jelgava, , Latvia

Site Status

1184.15.37153 Boehringer Ingelheim Investigational Site

Tukums, , Latvia

Site Status

1184.15.37053 Boehringer Ingelheim Investigational Site

Klaipėda, , Lithuania

Site Status

1184.15.31051 Boehringer Ingelheim Investigational Site

Breda, , Netherlands

Site Status

1184.15.31054 Boehringer Ingelheim Investigational Site

Utrecht, , Netherlands

Site Status

1184.15.31052 Boehringer Ingelheim Investigational Site

Zutphen, , Netherlands

Site Status

1184.15.42153 Boehringer Ingelheim Investigational Site

Bratislava, , Slovakia

Site Status

1184.15.42154 Boehringer Ingelheim Investigational Site

Bratislava, , Slovakia

Site Status

1184.15.27051

Bellville, , South Africa

Site Status

1184.15.27052

Cape Town, , South Africa

Site Status

1184.15.27053

Somerset West, , South Africa

Site Status

1184.15.82051 Boehringer Ingelheim Investigational Site

Jeonju, , South Korea

Site Status

1184.15.82052 Boehringer Ingelheim Investigational Site

Suwon, , South Korea

Site Status

1184.15.82053 Boehringer Ingelheim Investigational Site

Wŏnju, , South Korea

Site Status

1184.15.46053 Boehringer Ingelheim Investigational Site

Boden, , Sweden

Site Status

1184.15.46051 Boehringer Ingelheim Investigational Site

Stockholm, , Sweden

Site Status

Countries

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United States Austria Canada Denmark Estonia Finland France Germany Hungary Italy Latvia Lithuania Netherlands Slovakia South Africa South Korea Sweden

Related Links

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http://www.mystudywindow.com/

Related Info

Other Identifiers

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2007-005107-17

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1184.15

Identifier Type: -

Identifier Source: org_study_id

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