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Tiotropium/Salmeterol Inhalation Powder in COPD
Tiotropium/Salmeterol Inhalation Powder in COPD

NCT00668772

TerminatedPhase 3

Sponsor: Boehringer Ingelheim

Conditions: Pulmonary Disease, Chronic Obstructive

Interventions: Tiotropium/Salmeterol, Salmeterol, Placebo, Tiotropium

Countries: United States, Austria, Canada, Denmark, Estonia, Finland, France, Germany

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

Eligibility overview

Sex: ALL

Age: 40 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
Inclusion criteria:

Main:

* Diagnosis of chronic obstructive pulmonary disease (COPD)
* Post-bronchodilator forced expiratory volume in one second (FEV1) \<80% predicted and FEV1/forced vital capacity (FVC) \<70% predicted

Exclusion criteria:

Main:

* Significant other diseases then COPD
* Recent myocardial infarction (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
Locations (64)
  • Anniston, Alabama, United States
  • Mobile, Alabama, United States
  • Clearwater, Florida, United States
  • Tampa, Florida, United States
  • Tampa, Florida, United States
  • Savannah, Georgia, United States
  • New Orleans, Louisiana, United States
  • St Louis, Missouri, United States
  • St Louis, Missouri, United States
  • St Louis, Missouri, United States
  • Summit, New Jersey, United States
  • Albuquerque, New Mexico, United States
  • New York, New York, United States
  • Elizabeth City, North Carolina, United States
  • Charleston, South Carolina, United States
  • Morgantown, West Virginia, United States
  • Gänserndorf, Austria
  • Vienna, Austria
  • Vancouver, British Columbia, Canada
  • Vancouver, British Columbia, Canada
  • Hamilton, Ontario, Canada
  • Ottawa, Ontario, Canada
  • Scarborough Village, Ontario, Canada
  • Toronto, Ontario, Canada
  • Longueuil, Quebec, Canada
  • Montreal, Quebec, Canada
  • Aalborg, Denmark
  • Kolding, Denmark
  • Odense C, Denmark
  • Silkeborg, Denmark
  • + 34 more on CT.gov