Exacerbation Study (INVIGORATE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00845728
Recruitment Status : Completed
First Posted : February 18, 2009
Results First Posted : November 19, 2013
Last Update Posted : November 19, 2013
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Chronic Obstructive Pulmonary Disease
Interventions: Drug: Indacaterol 150 µg
Drug: Tiotropium

  Participant Flow

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

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

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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  More Information