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Exacerbation Study (INVIGORATE)

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: February 15, 2009
Last updated: September 16, 2013
Last verified: September 2013
Results First Received: July 3, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Chronic Obstructive Pulmonary Disease
Interventions: Drug: Indacaterol 150 µg
Drug: Tiotropium

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
3,444 patients were randomized, but only 3,439 received treatment as 5 patients were mis-randomized.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

Indacaterol 150 μg o.d., delivered via SDDPI o.d. plus placebo to tiotropium o.d.

delivered via the manufacturer’s proprietary inhalation device (Handihaler®)

Tiotropium Tiotropium 18 μg o.d. delivered via the manufacturer’s proprietary inhalation device (Handihaler®) plus placebo to indacaterol o.d. delivered via SDDPI

Participant Flow:   Overall Study
    Indacaterol     Tiotropium  
STARTED     1723     1721  
Exposed     1721     1718  
COMPLETED     1337     1379  
NOT COMPLETED     386     342  
Abnormal laboratory value (s)                 2                 2  
Patient's inability to use the device                 4                 6  
Abnormal test procedure result (s)                 7                 2  
Lost to Follow-up                 22                 13  
Death                 24                 26  
Administrative Problems                 34                 26  
Protocol Violation                 36                 24  
Lack of Efficacy                 51                 39  
Adverse Event                 101                 96  
Withdrawal by Subject                 105                 108  

  Baseline Characteristics

  Outcome Measures
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1.  Primary:   Trough Forced Expiratory Volume in 1 Second (FEV1).   [ Time Frame: 12 weeks ]

2.  Secondary:   Rate of COPD Exacerbations   [ Time Frame: 52 weeks ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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