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 )

February 15, 2009
February 18, 2009
July 3, 2013
November 19, 2013
November 19, 2013
March 2009
July 2012   (Final data collection date for primary outcome measure)
Trough Forced Expiratory Volume in 1 Second (FEV1). [ Time Frame: 12 weeks ]
The primary objective of the study was to demonstrate the non-inferiority of indacaterol vs. tiotropium with respect to 24 hour post dose (trough) FEV1 after 12 weeks of treatment in patients with severe COPD. Trough FEV1 was defined as the average of the 23 hours 10 min and the 23 hours 45 min post dose values. Trough FEV1 was analyzed using a mixed model for the PPS-S. The model contained treatment as a fixed effect with the baseline FEV1, FEV1 prior to inhalation and FEV1 15 min post-inhalation of salbutamol/albuterol (components of SABA reversibility at Visit 2), FEV1 prior to inhalation and FEV1 60 min post-inhalation of ipratropium (components of anti-cholinergic reversibility at Visit 3) as covariates. Smoking history (current or ex-smoker) was included as a factor in the model.
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 ]
Complete list of historical versions of study NCT00845728 on Archive Site
Rate of COPD Exacerbations [ Time Frame: 52 weeks ]
COPD exacerbations were defined as :Worsening of 2 or more major symptoms for at least 2 consecutive days: dyspnea; sputum volume; suputum purulence AND requiring treatment with systemic corticosteroids and/or antibiotics OR Worsening of any 1 major symptom together with any 1 of the following minor symptoms for at least 2 consecutive days: Sore throat; colds; fever without other cause; increased cough; increase wheeze AND requiring treatment with systemic glucocorticosteroids and/or antibiotics. The rate was analyzed using a linear model assuming a negative binomial distribution for the PPS-E. The time at risk for a patient was defined as the length of time the patient was in the study and the log(length of time in the study) was used as the offset variable in the model.
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 ]
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Exacerbation Study
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
This study compares indacaterol with tiotropium in terms of bronchodilation over 52 weeks
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Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
  • Drug: Indacaterol 150 µg
    Indacaterol 150 µg o.d. delivered via SDDPI
  • Drug: Tiotropium
    Tiotropium 18 µg o.d. delivered via handihaler®
  • Experimental: Indacaterol
    Indacaterol 150 µg o.d. delivered via single-dose dry powder inhaler (SDDPI)
    Intervention: Drug: Indacaterol 150 µg
  • Active Comparator: Tiotropium
    Tiotropium 18 µg o.d. delivered via the handihaler®
    Intervention: Drug: Tiotropium
Decramer ML, Chapman KR, Dahl R, Frith P, Devouassoux G, Fritscher C, Cameron R, Shoaib M, Lawrence D, Young D, McBryan D; INVIGORATE investigators. Once-daily indacaterol versus tiotropium for patients with severe chronic obstructive pulmonary disease (INVIGORATE): a randomised, blinded, parallel-group study. Lancet Respir Med. 2013 Sep;1(7):524-33. doi: 10.1016/S2213-2600(13)70158-9. Epub 2013 Aug 21.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2012
July 2012   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
40 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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,   Peru,   Philippines,   Poland,   Portugal,   Romania,   Russian Federation,   Slovakia,   South Africa,   Spain,   Sweden,   Switzerland,   Taiwan,   Thailand,   Turkey,   United Kingdom,   Venezuela
New Zealand
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Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP