Exacerbation Study (INVIGORATE)

Novartis

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Tiotropium; Drug: Indacaterol 150 µg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00845728

CQAB149B2348

2008-007944-33

Details and patient eligibility

About

This study compares indacaterol with tiotropium in terms of bronchodilation over 52 weeks

Enrollment: 3,439 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female adults aged ≥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

• 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

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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3,439 participants in 2 patient groups

Indacaterol

Experimental group

Description:

Indacaterol 150 µg o.d. delivered via single-dose dry powder inhaler (SDDPI)

Treatment:

Drug: Indacaterol 150 µg

Tiotropium

Active Comparator group

Description:

Tiotropium 18 µg o.d. delivered via the handihaler®

Treatment:

Drug: Tiotropium