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Tiotropium/Salmeterol Inhalation Powder (Spiriva Handihaler and Salmeterol Polyethylene (PE) Capsule) in Chronic Obstructive Pulmonary Disease (COPD)

NCT ID: NCT00662740

Last Updated: 2023-08-23

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

220 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 forced expiratory volume in one second (FEV1), the effect on dyspnoea as determined by the Baseline Dyspnoea Index/Transition Dyspnoea Index (BDI/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.

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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 quaque die (QD, once daily)

Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule

Group Type EXPERIMENTAL

Tiotropium/Salmeterol QD

Intervention Type DRUG

Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene Capsule

Tiotropium quaque die (QD, once daily)

Tiotropium Inhalation Powder, hard gelatine capsule (Spiriva®)

Group Type ACTIVE_COMPARATOR

Tiotropium (Spiriva®)

Intervention Type DRUG

Tiotropium, Spiriva®

Salmeterol bis in die (BID, twice daily)

Salmeterol Inhalation Powder, hard PE capsule

Group Type ACTIVE_COMPARATOR

Salmeterol

Intervention Type DRUG

Salmeterol Inhalation Powder, hard PE capsule

Tiotropium/Salmeterol quaque die (QD, once daily)+ 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 QD

Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene 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/Salmeterol QD+ Salmeterol

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

Intervention Type DRUG

Tiotropium (Spiriva®)

Tiotropium, Spiriva®

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Significant other diseases then COPD
* Recent myocardial infarction (MI)
* Unstable or life-threatening arrythmia requiring intervention or change in drug therapy
* Hospitalisation for cardiac failure in 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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1184.14.01013 Boehringer Ingelheim Investigational Site

Boulder, Colorado, United States

Site Status

1184.14.01018 Boehringer Ingelheim Investigational Site

Wheat Ridge, Colorado, United States

Site Status

1184.14.01006 Boehringer Ingelheim Investigational Site

Winter Park, Florida, United States

Site Status

1184.14.01003 Boehringer Ingelheim Investigational Site

Coeur d'Alene, Idaho, United States

Site Status

1184.14.01015 Boehringer Ingelheim Investigational Site

South Bend, Indiana, United States

Site Status

1184.14.01007 Boehringer Ingelheim Investigational Site

Lafayette, Louisiana, United States

Site Status

1184.14.01005 Boehringer Ingelheim Investigational Site

Bangor, Maine, United States

Site Status

1184.14.01020 Boehringer Ingelheim Investigational Site

Edina, Minnesota, United States

Site Status

1184.14.01009 Boehringer Ingelheim Investigational Site

Burlington, North Carolina, United States

Site Status

1184.14.01002 Boehringer Ingelheim Investigational Site

Cincinnati, Ohio, United States

Site Status

1184.14.01021 Boehringer Ingelheim Investigational Site

Toledo, Ohio, United States

Site Status

1184.14.01012 Boehringer Ingelheim Investigational Site

East Providence, Rhode Island, United States

Site Status

1184.14.01017 Boehringer Ingelheim Investigational Site

Greenville, South Carolina, United States

Site Status

1184.14.01008 Boehringer Ingelheim Investigational Site

Spartanburg, South Carolina, United States

Site Status

1184.14.01014 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Site Status

1184.14.01022 Boehringer Ingelheim Investigational Site

Killeen, Texas, United States

Site Status

1184.14.01001 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Site Status

1184.14.01010 Boehringer Ingelheim Investigational Site

Temple, Texas, United States

Site Status

1184.14.01011 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Site Status

1184.14.01019 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Site Status

1184.14.43001 Boehringer Ingelheim Investigational Site

Feldbach, , Austria

Site Status

1184.14.32001 Boehringer Ingelheim Investigational Site

Brussels, , Belgium

Site Status

1184.14.32004 Boehringer Ingelheim Investigational Site

Turnhout, , Belgium

Site Status

1184.14.02005 Boehringer Ingelheim Investigational Site

Calgary, Alberta, Canada

Site Status

1184.14.02003 Boehringer Ingelheim Investigational Site

Chilliwack, British Columbia, Canada

Site Status

1184.14.02010 Boehringer Ingelheim Investigational Site

Vancouver, British Columbia, Canada

Site Status

1184.14.02001 Boehringer Ingelheim Investigational Site

Niagara Falls, Ontario, Canada

Site Status

1184.14.02002 Boehringer Ingelheim Investigational Site

La Malbaie, Quebec, Canada

Site Status

1184.14.02008 Boehringer Ingelheim Investigational Site

Ste-Foy, Quebec, Canada

Site Status

1184.14.02007 Boehringer Ingelheim Investigational Site

Saskatoon, Saskatchewan, Canada

Site Status

1184.14.45001 Boehringer Ingelheim Investigational Site

Hvidovre, , Denmark

Site Status

1184.14.45002 Boehringer Ingelheim Investigational Site

København NV, , Denmark

Site Status

1184.14.37202 Boehringer Ingelheim Investigational Site

Tallinn, , Estonia

Site Status

1184.14.37201 Boehringer Ingelheim Investigational Site

Tartu, , Estonia

Site Status

1184.14.35802 Boehringer Ingelheim Investigational Site

Espoo, , Finland

Site Status

1184.14.35801 Boehringer Ingelheim Investigational Site

HUS, , Finland

Site Status

1184.14.3301A Boehringer Ingelheim Investigational Site

Brest, , France

Site Status

1184.14.3304A Boehringer Ingelheim Investigational Site

Marseille, , France

Site Status

1184.14.3302A Boehringer Ingelheim Investigational Site

Montpellier, , France

Site Status

1184.14.3303A Boehringer Ingelheim Investigational Site

Perpignan, , France

Site Status

1184.14.3303B Boehringer Ingelheim Investigational Site

Perpignan, , France

Site Status

1184.14.3303C Boehringer Ingelheim Investigational Site

Perpignan, , France

Site Status

1184.14.49003 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1184.14.49004 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1184.14.49006 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1184.14.49008 Boehringer Ingelheim Investigational Site

Berlin, , Germany

Site Status

1184.14.49002 Boehringer Ingelheim Investigational Site

Hamburg, , Germany

Site Status

1184.14.49007 Boehringer Ingelheim Investigational Site

Hamburg, , Germany

Site Status

1184.14.49001 Boehringer Ingelheim Investigational Site

Leipzig, , Germany

Site Status

1184.14.30001 Boehringer Ingelheim Investigational Site

Athens, , Greece

Site Status

1184.14.30004 Boehringer Ingelheim Investigational Site

Nafplion, , Greece

Site Status

1184.14.30006 Boehringer Ingelheim Investigational Site

Rethymno, , Greece

Site Status

1184.14.36002 Boehringer Ingelheim Investigational Site

Debrecen, , Hungary

Site Status

1184.14.36001 Boehringer Ingelheim Investigational Site

Hodmezövasarhely, , Hungary

Site Status

1184.14.36005 Boehringer Ingelheim Investigational Site

Komló, , Hungary

Site Status

1184.14.36004 Boehringer Ingelheim Investigational Site

Miskolc, , Hungary

Site Status

1184.14.39001 Boehringer Ingelheim Investigational Site

Pisa, , Italy

Site Status

1184.14.37101 Boehringer Ingelheim Investigational Site

Krāslava, , Latvia

Site Status

1184.14.37103 Boehringer Ingelheim Investigational Site

Kuldīga, , Latvia

Site Status

1184.14.37102 Boehringer Ingelheim Investigational Site

Talsi, , Latvia

Site Status

1184.14.37003 Boehringer Ingelheim Investigational Site

Klaipėda, , Lithuania

Site Status

1184.14.31004 Boehringer Ingelheim Investigational Site

Eindhoven, , Netherlands

Site Status

1184.14.31003 Boehringer Ingelheim Investigational Site

Heerlen, , Netherlands

Site Status

1184.14.31002 Boehringer Ingelheim Investigational Site

Nieuwegein, , Netherlands

Site Status

1184.14.31001 Boehringer Ingelheim Investigational Site

Veldhoven, , Netherlands

Site Status

1184.14.42103 Boehringer Ingelheim Investigational Site

Bardejov, , Slovakia

Site Status

1184.14.82001 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1184.14.82002 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1184.14.82003 Boehringer Ingelheim Investigational Site

Seoul, , South Korea

Site Status

1184.14.46002 Boehringer Ingelheim Investigational Site

Linköping, , Sweden

Site Status

1184.14.46001 Boehringer Ingelheim Investigational Site

Lund, , Sweden

Site Status

1184.14.46003 Boehringer Ingelheim Investigational Site

Sundsvall, , Sweden

Site Status

Countries

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

Related Links

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http://www.mystudywindow.com/

Related Info

Other Identifiers

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2007-005134-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1184.14

Identifier Type: -

Identifier Source: org_study_id

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