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Tiotropium/Salmeterol Inhalation Powder (Spiriva Handihaler and Salmeterol Polyethylene (PE) Capsule) in Chronic Obstructive Pulmonary Disease (COPD)
Sponsor: Boehringer Ingelheim
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/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.
Official title: 1-yr Study Comparing TioSal Combo Regimens Versus Single Agent Therapies (Spiriva HandiHaler and Salmeterol PE Capsule)
Key Details
Gender
All
Age Range
40 Years - Any
Study Type
INTERVENTIONAL
Enrollment
220
Start Date
2008-04-15
Completion Date
2008-11-21
Last Updated
2026-10-29
Healthy Volunteers
No
Conditions
Interventions
FDC tiotropium / salmeterol
Fixed-dose combination Tiotropium/Salmeterol Inhalation Powder, Hard Polyethylene (PE) Capsule
Placebo
Placebo Inhalation Powder, hard PE capsule / hard gelatine capsule
Salmeterol
Salmeterol Inhalation Powder, hard PE capsule
Tiotropium (Spiriva®)
Tiotropium, Spiriva®
Locations (72)
1184.14.01013 Boehringer Ingelheim Investigational Site
Boulder, Colorado, United States
1184.14.01018 Boehringer Ingelheim Investigational Site
Wheat Ridge, Colorado, United States
1184.14.01006 Boehringer Ingelheim Investigational Site
Winter Park, Florida, United States
1184.14.01003 Boehringer Ingelheim Investigational Site
Coeur d'Alene, Idaho, United States
1184.14.01015 Boehringer Ingelheim Investigational Site
South Bend, Indiana, United States
1184.14.01007 Boehringer Ingelheim Investigational Site
Lafayette, Louisiana, United States
1184.14.01005 Boehringer Ingelheim Investigational Site
Bangor, Maine, United States
1184.14.01020 Boehringer Ingelheim Investigational Site
Edina, Minnesota, United States
1184.14.01009 Boehringer Ingelheim Investigational Site
Burlington, North Carolina, United States
1184.14.01002 Boehringer Ingelheim Investigational Site
Cincinnati, Ohio, United States
1184.14.01021 Boehringer Ingelheim Investigational Site
Toledo, Ohio, United States
1184.14.01012 Boehringer Ingelheim Investigational Site
East Providence, Rhode Island, United States
1184.14.01017 Boehringer Ingelheim Investigational Site
Greenville, South Carolina, United States
1184.14.01008 Boehringer Ingelheim Investigational Site
Spartanburg, South Carolina, United States
1184.14.01014 Boehringer Ingelheim Investigational Site
Houston, Texas, United States
1184.14.01022 Boehringer Ingelheim Investigational Site
Killeen, Texas, United States
1184.14.01001 Boehringer Ingelheim Investigational Site
San Antonio, Texas, United States
1184.14.01010 Boehringer Ingelheim Investigational Site
Temple, Texas, United States
1184.14.01011 Boehringer Ingelheim Investigational Site
Richmond, Virginia, United States
1184.14.01019 Boehringer Ingelheim Investigational Site
Richmond, Virginia, United States
1184.14.43001 Boehringer Ingelheim Investigational Site
Feldbach, Austria
1184.14.32001 Boehringer Ingelheim Investigational Site
Brussels, Belgium
1184.14.32004 Boehringer Ingelheim Investigational Site
Turnhout, Belgium
1184.14.02005 Boehringer Ingelheim Investigational Site
Calgary, Alberta, Canada
1184.14.02003 Boehringer Ingelheim Investigational Site
Chilliwack, British Columbia, Canada
1184.14.02010 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia, Canada
1184.14.02001 Boehringer Ingelheim Investigational Site
Niagara Falls, Ontario, Canada
1184.14.02002 Boehringer Ingelheim Investigational Site
La Malbaie, Quebec, Canada
1184.14.02008 Boehringer Ingelheim Investigational Site
Ste-Foy, Quebec, Canada
1184.14.02007 Boehringer Ingelheim Investigational Site
Saskatoon, Saskatchewan, Canada
1184.14.45001 Boehringer Ingelheim Investigational Site
Hvidovre, Denmark
1184.14.45002 Boehringer Ingelheim Investigational Site
København NV, Denmark
1184.14.37202 Boehringer Ingelheim Investigational Site
Tallinn, Estonia
1184.14.37201 Boehringer Ingelheim Investigational Site
Tartu, Estonia
1184.14.35802 Boehringer Ingelheim Investigational Site
Espoo, Finland
1184.14.35801 Boehringer Ingelheim Investigational Site
HUS, Finland
1184.14.3301A Boehringer Ingelheim Investigational Site
Brest, France
1184.14.3304A Boehringer Ingelheim Investigational Site
Marseille, France
1184.14.3302A Boehringer Ingelheim Investigational Site
Montpellier, France
1184.14.3303A Boehringer Ingelheim Investigational Site
Perpignan, France
1184.14.3303B Boehringer Ingelheim Investigational Site
Perpignan, France
1184.14.3303C Boehringer Ingelheim Investigational Site
Perpignan, France
1184.14.49003 Boehringer Ingelheim Investigational Site
Berlin, Germany
1184.14.49004 Boehringer Ingelheim Investigational Site
Berlin, Germany
1184.14.49006 Boehringer Ingelheim Investigational Site
Berlin, Germany
1184.14.49008 Boehringer Ingelheim Investigational Site
Berlin, Germany
1184.14.49002 Boehringer Ingelheim Investigational Site
Hamburg, Germany
1184.14.49007 Boehringer Ingelheim Investigational Site
Hamburg, Germany
1184.14.49001 Boehringer Ingelheim Investigational Site
Leipzig, Germany
1184.14.30001 Boehringer Ingelheim Investigational Site
Athens, Greece
1184.14.30004 Boehringer Ingelheim Investigational Site
Nafplion, Greece
1184.14.30006 Boehringer Ingelheim Investigational Site
Rethymno, Greece
1184.14.36002 Boehringer Ingelheim Investigational Site
Debrecen, Hungary
1184.14.36001 Boehringer Ingelheim Investigational Site
Hodmezövasarhely, Hungary
1184.14.36005 Boehringer Ingelheim Investigational Site
Komló, Hungary
1184.14.36004 Boehringer Ingelheim Investigational Site
Miskolc, Hungary
1184.14.39001 Boehringer Ingelheim Investigational Site
Pisa, Italy
1184.14.37101 Boehringer Ingelheim Investigational Site
Krāslava, Latvia
1184.14.37103 Boehringer Ingelheim Investigational Site
Kuldīga, Latvia
1184.14.37102 Boehringer Ingelheim Investigational Site
Talsi, Latvia
1184.14.37003 Boehringer Ingelheim Investigational Site
Klaipėda, Lithuania
1184.14.31004 Boehringer Ingelheim Investigational Site
Eindhoven, Netherlands
1184.14.31003 Boehringer Ingelheim Investigational Site
Heerlen, Netherlands
1184.14.31002 Boehringer Ingelheim Investigational Site
Nieuwegein, Netherlands
1184.14.31001 Boehringer Ingelheim Investigational Site
Veldhoven, Netherlands
1184.14.42103 Boehringer Ingelheim Investigational Site
Bardejov, Slovakia
1184.14.82001 Boehringer Ingelheim Investigational Site
Seoul, South Korea
1184.14.82002 Boehringer Ingelheim Investigational Site
Seoul, South Korea
1184.14.82003 Boehringer Ingelheim Investigational Site
Seoul, South Korea
1184.14.46002 Boehringer Ingelheim Investigational Site
Linköping, Sweden
1184.14.46001 Boehringer Ingelheim Investigational Site
Lund, Sweden
1184.14.46003 Boehringer Ingelheim Investigational Site
Sundsvall, Sweden