Comparison of Indacaterol and Tiotropium on Lung Function and Related Outcomes in Patients With Chronic Obstructive Pulmonary Disease (COPD) (INVIGORATE)

A phase IIIb multicenter, 52 week treatment, randomized, blinded, double dummy, parallel group efficacy study comparing the effect of inhaled indacaterol 150 µg o.d. vs inhaled tiotropium 18 µg o.d. on lung function, rate of exacerbations and related outcomes in patients with COPD

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2009/091/000277

Enrollment

3500

Registered

2009-06-15

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Chronic Obstructive Pulmonary Disease

Interventions

Intervention1: Indacaterol: Indacaterol 150 µg o.d. delivered via single-dose dry powder inhaler (SDDPI)throughout the study duration Control Intervention1: Tiotropium: Tiotropium 18 &micro

g o.d. delivered via SDDPI Control Intervention2: Placebo: Placebo to indacterol delivered via single-dose dry-powder inhaler (SDDPI) o.d. Control Intervention3: Placebo: Placebo to tiotropium deliv

Eligibility

Inclusion criteria

Inclusion criteria: Male and female adults aged greater than or equal to 40 years, who have signed an Informed Consent form prior to initiation of any study-related procedure Patients diagnosed with COPD at age 40 and over and with a current diagnosis of severe COPD and including: 1. Smoking history of at least 10 pack years, both current and ex-smokers are eligible 2. A documented history of at least 1 moderate or severe exacerbation in the previous 12 months

Exclusion criteria

Exclusion criteria: Patients who have received systemic corticosteroids and/or antibiotics for a COPD exacerbation in the 6 weeks prior to screening or during the run-in period Patients who have had a respiratory tract infection within 6 weeks prior to screening Patients with concomitant pulmonary disease Patients with a history of asthma Patients with diabetes Type I or uncontrolled diabetes Type II Any patient with lung cancer or a history of lung cancer Patients with a history of certain cardiovascular comorbid conditions

Design outcomes

Primary

Measure	Time frame
Comparison of indacaterol 150 µg once daily (o.d.) versus tiotropium 18 µg o.d. with respect to trough forced expiratory volume in 1 second (FEV1)Timepoint: 12 weeks	—

Secondary

Measure	Time frame
Comparison of indacaterol 150 µg o.d. vs tiotropium 18 µg o.d. with regard to the rate of COPD exacerbationsTimepoint: 52 weeks	—

Countries

Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Costa Rica, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hungary, Iceland, India, Israel, Italy, Latvia, Lithuania, Mexico, Netherlands, New Zealand, Peru, Philippines, Poland, Portugal, Romania, Russian Federation, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, Venezuela (Bolivarian Republic of)

Contacts

Public ContactMurugananthan K

Novartis Healtcare Pvt Ltd

murugananthan.k@novartis.com02224958545

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026