CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 5,993 enrolled
Drug / intervention
tiotropium +1 moredrug
Likely dose
tiotropium 18 mcg inhalation capsule once dailyAI-extracted
Key inclusion· 5
  • ✓Age 40 years or older
  • ✓Smoking history of at least 10 pack years
  • ✓COPD diagnosis with post-bronchodilator FEV1 ≤70% predicted normal
  • ✓FEV1 <70% of FVC
Key exclusion· 14
  • ✕Myocardial infarction within past 6 months
  • ✕Unstable or life-threatening arrhythmia within past year
  • ✕Hospitalization for NYHA heart failure class III or IV within past year
  • ✕Active tuberculosis

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00144339
NCT00144339Phase 3Completed
CompareCT.gov

A Randomized, Double-blind, Placebo-controlled, Parallel Group Trial Assessing the Rate of Decline of Lung Function With Tiotropium 18 mcg Inhalation Capsule Once Daily in Patients With Chronic Obstructive Pulmonary Disease (COPD).

Boehringer Ingelheim·interventional·Posted Sep 5, 2005·Updated May 20, 2014

In Brief

A Phase 3 clinical trial evaluating tiotropium and placebo for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 5,993 participants across 490 sites in 37 countries.

Detailed Summary

The primary objective of this trial is to determine whether daily treatment with tiotropium (Spiriva®, Bromuro de Tiotropio®) inhalation capsule via HandiHaler® reduces the rate of decline in lung function over time in patients with COPD.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Disease, Chronic Obstructive
CountriesArgentina, Australia, Austria, Belgium, Brazil, Czechia, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Ireland, Italy, Japan, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Philippines, Poland, Portugal, Russia, Singapore, Slovakia, Slovenia, South Africa, Spain, Switzerland, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 5, 2005
Enrollment StartDec 1, 2002
Primary CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 20.8 years ago

Interventions

tiotropiumdrug

placebodrug