At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 568 enrolled
Drug / intervention
indacaterol +4 moredrug
Likely dose
short acting β2- agonist 100 μgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Multi-center, Parallel Group, Double Blind, Placebo and Formoterol Controlled 14 Day Dose Ranging Trial of 4 Doses of Indacaterol Delivered Via TWISTHALER® Device in Patients With COPD
In Brief
A Phase 2 clinical trial evaluating indacaterol, formoterol, and 3 other interventions for COPD. Completed, enrolled 568 participants across 75 sites in 17 countries.
Detailed Summary
This study will evaluate the dose response relationship among four doses of indacaterol as well as placebo delivered via the TWISTHALER® device.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOPD
CountriesArgentina, Belgium, Chile, France, Germany, Hungary, Ireland, Italy, Latvia, Lithuania, Norway, Peru, Poland, Romania, South Africa, Turkey (Türkiye), United Kingdom
CollaboratorsSchering-Plough
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2007
First PostedNov 2007
Primary CompletionMay 2008
TodayJul 2026
First PostedNov 14, 2007
Enrollment StartOct 1, 2007
Primary CompletionMay 1, 2008
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 18.6 years ago
Interventions
indacateroldrug
Indacaterol delivered by multiple dose dry powder inhaler (TWISTHALER® device).
formoteroldrug
Formoterol delivered by oral inhalation via AEROLIZER® inhalation device.
placebo to indacateroldrug
Placebo TWISTHALER® device
placebo to formoteroldrug
Placebo AEROLIZER® device
short acting β2- agonistdrug
100 μg / 90 μg salbutamol/albuterol Metered Dose Inhaler (MDI) or equivalent dose of Dry Powder Inhaler (DPI).