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 )

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

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Indacaterol 150 µg Drug: Tiotropium Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3439 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : March 2009
Primary Completion Date : July 2012
Study Completion Date : July 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Indacaterol
Indacaterol 150 µg o.d. delivered via single-dose dry powder inhaler (SDDPI)
Drug: Indacaterol 150 µg
Indacaterol 150 µg o.d. delivered via SDDPI
Active Comparator: Tiotropium
Tiotropium 18 µg o.d. delivered via the handihaler®
Drug: Tiotropium
Tiotropium 18 µg o.d. delivered via handihaler®

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00845728

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Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals Identifier: NCT00845728     History of Changes
Other Study ID Numbers: CQAB149B2348
First Posted: February 18, 2009    Key Record Dates
Results First Posted: November 19, 2013
Last Update Posted: November 19, 2013
Last Verified: September 2013

Keywords provided by Novartis ( Novartis Pharmaceuticals ):

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Tiotropium Bromide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action