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


Tracking Information

Start Date  ICMJEMarch 2009
Estimated Primary Completion DateJuly 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 17, 2009)		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). [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00845728 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: February 17, 2009)		Comparison of indacaterol 150 µg o.d. vs tiotropium 18 µg o.d. with regard to the rate of COPD exacerbations [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ICMJESame as current

Descriptive Information

Brief Title  ICMJEComparison of Indacaterol and Tiotropium on Lung Function and Related Outcomes in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official Title  ICMJE 
Brief Summary

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

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment
Condition  ICMJEChronic Obstructive Pulmonary Disease
Intervention  ICMJE
  • Drug: Indacaterol 150 µg
    Indacaterol 150 µg o.d. delivered via SDDPI
  • Drug: Tiotropium
    Tiotropium 18 µg o.d. delivered via SDDPI
Study Arms / Comparison Groups
  • Indacaterol: Experimental
    Indacaterol 150 µg o.d. delivered via single-dose dry powder inhaler (SDDPI)
    Intervention: Drug: Indacaterol 150 µg
  • Tiotropium: Active Comparator
    Tiotropium 18 µg o.d. delivered via SDDPI
    Intervention: Drug: Tiotropium

Recruitment Information

Estimated Enrollment  ICMJE3500
Completion Date 
Estimated Primary Completion DateJuly 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

GenderBoth
Ages40 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Novartis Pharmaceuticals+41-61-324-1111
Location Countries  ICMJEArgentina,   Australia,   Austria,   Belgium,   Canada,   Colombia,   Costa Rica,   Czech Republic,   Denmark,   Estonia,   Finland,   France,   Germany,   Hungary,   Iceland,   India,   Israel,   Italy,   Latvia,   Lithuania,   Netherlands,   New Zealand,   Peru,   Poland,   Portugal,   Romania,   Russian Federation,   Slovakia,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   Turkey,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00845728
Responsible PartyExternal Affairs, Novartis Pharmaceuticals
Study ID Numbers  ICMJECQAB149B2348
Study Sponsor  ICMJENovartis Pharmaceuticals
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Novartis PharmaceuticalsNovartis Pharmaceuticals
Information Provided ByNovartis