CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,059 enrolled
Drug / intervention
Indacaterol +4 moredrug
Likely dose
Indacaterol 75, 150, 300, or 600 µg once daily (dose to be selected); Formoterol 12 µg twice daily; Tiotropium 18 µg once dailyAI-extracted
Key inclusion· 6
  • ✓Age ≥40 years
  • ✓Diagnosis of moderate to severe COPD per GOLD 2005 guidelines
  • ✓Smoking history of at least 20 pack-years
  • ✓Post-bronchodilator FEV1 between 30–80% of predicted
Key exclusion· 12
  • ✕COPD hospitalization within 6 weeks prior to Visit 1 or during run-in
  • ✕Long-term oxygen therapy >15 hours per day
  • ✕Respiratory tract infection within 6 weeks prior to Visit 1
  • ✕History of asthma

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

Search/NCT00463567
NCT00463567Phase 3Completed
CompareCT.gov

A 26-week Treatment, Multicenter, Randomized, Double Blind, Double Dummy, Placebo-controlled, Adaptive, Seamless, Parallel-group Study to Assess the Efficacy, Safety and Tolerability of Two Doses of Indacaterol (Selected From 75, 150, 300 & 600 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease Using Blinded Formoterol (12 µg b.i.d.) and Open Label Tiotropium (18 µg o.d.) as Active Controls

Novartis·interventional·Posted Apr 20, 2007·Updated Aug 18, 2011

In Brief

A Phase 3 clinical trial evaluating Indacaterol, Formoterol (12 µg b.i.d.), and 3 other interventions for Pulmonary Disease, Chronic Obstructive and 2 related conditions. Completed, enrolled 2,059 participants across 344 sites in 12 countries.

Detailed Summary

Stage 1 of the study is designed to provide data about the risk-benefit of 4 dose regimens of indacaterol (75, 150, 300 \& 600 µg o.d.) in order to select two doses to carry forward into study Stage 2. Study Stage 2 will provide pivotal confirmation of efficacy, safety, and tolerability of the selected indacaterol doses in patients with COPD

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Disease, Chronic Obstructive, COPD, Lung Diseases, Obstructive
CountriesArgentina, Canada, Germany, India, Italy, Puerto Rico, South Korea, Spain, Sweden, Taiwan, Turkey (Türkiye), United States
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedApr 20, 2007
Enrollment StartApr 1, 2007
Primary CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 19.2 years ago

Interventions

Indacateroldrug

In the morning, Indacaterol once daily (o.d.) orally inhaled via a single dose dry powder inhaler (SDDPI).

Formoterol (12 µg b.i.d.)drug

Formoterol 12 µg twice daily (b.i.d.) in the morning and in the evening via an aerolizer.

Tiotropium (18 µg o.d.)drug

Tiotropium 18 µg once daily (o.d.) dry powder capsules delivered via a SDDPI.

Placebo to Indacateroldrug

In the morning, Placebo to Indacaterol once daily (o.d.) orally inhaled via a single dose dry powder inhaler (SDDPI).

Placebo to Formoteroldrug

In the morning and in the evening, placebo to formoterol delivered via Aerolizer.