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Trial record 30 of 158 for:    Diseases | ( Map: Costa Rica )

Exacerbation Study (INVIGORATE)

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ClinicalTrials.gov Identifier: NCT00845728
Recruitment Status : Completed
First Posted : February 18, 2009
Results First Posted : November 19, 2013
Last Update Posted : November 19, 2013
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Tracking Information
First Submitted Date  ICMJE February 15, 2009
First Posted Date  ICMJE February 18, 2009
Results First Submitted Date  ICMJE July 3, 2013
Results First Posted Date  ICMJE November 19, 2013
Last Update Posted Date November 19, 2013
Study Start Date  ICMJE March 2009
Actual Primary Completion Date July 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 16, 2013)
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.
Original 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 ]
Change History Complete list of historical versions of study NCT00845728 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 16, 2013)
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.
Original 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exacerbation Study
Official Title  ICMJE 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
Brief Summary This study compares indacaterol with tiotropium in terms of bronchodilation over 52 weeks
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Chronic 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 handihaler®
Study Arms  ICMJE
  • 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
Publications * 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 6, 2012)
3439
Original Estimated Enrollment  ICMJE
 (submitted: February 17, 2009)
3500
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date July 2012   (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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Costa Rica,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   China,   Colombia,   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
Removed Location Countries New Zealand
 
Administrative Information
NCT Number  ICMJE NCT00845728
Other Study ID Numbers  ICMJE CQAB149B2348
2008-007944-33
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Novartis ( Novartis Pharmaceuticals )
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date September 2013

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