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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00845728
Registration number
NCT00845728
Ethics application status
Date submitted
15/02/2009
Date registered
18/02/2009
Date last updated
19/11/2013
Titles & IDs
Public title
Exacerbation Study
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Scientific 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
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Secondary ID [1]
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2008-007944-33
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Secondary ID [2]
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CQAB149B2348
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Universal Trial Number (UTN)
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Trial acronym
INVIGORATE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease
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Condition category
Condition code
Respiratory
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0
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Chronic obstructive pulmonary disease
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Indacaterol 150 µg
Treatment: Drugs - Tiotropium
Experimental: Indacaterol - Indacaterol 150 µg o.d. delivered via single-dose dry powder inhaler (SDDPI)
Active comparator: Tiotropium - Tiotropium 18 µg o.d. delivered via the handihaler®
Treatment: Drugs: Indacaterol 150 µg
Indacaterol 150 µg o.d. delivered via SDDPI
Treatment: Drugs: Tiotropium
Tiotropium 18 µg o.d. delivered via handihaler®
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Trough Forced Expiratory Volume in 1 Second (FEV1).
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Assessment method [1]
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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.
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Timepoint [1]
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12 weeks
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Secondary outcome [1]
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Rate of COPD Exacerbations
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Assessment method [1]
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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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Timepoint [1]
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52 weeks
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Eligibility
Key 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
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Minimum age
40
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/03/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/07/2012
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Sample size
Target
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Accrual to date
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Final
3439
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
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Recruitment hospital [1]
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Novartis Investigative Site - Bankstown
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Novartis Investigative Site - Adelaide
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Novartis Investigative Site - Daw Park
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Novartis Investigative Site - Heidelberg
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Novartis Investigative Site - Parkville
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Novartis Investigative Site - Nedlands
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Recruitment hospital [7]
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Novartis Investigative Site - Tauranga, New Zealand
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Recruitment postcode(s) [1]
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2200 - Bankstown
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Recruitment postcode(s) [2]
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5000 - Adelaide
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Recruitment postcode(s) [3]
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5041 - Daw Park
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Recruitment postcode(s) [4]
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3084 - Heidelberg
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Recruitment postcode(s) [5]
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3050 - Parkville
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Recruitment postcode(s) [6]
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6009 - Nedlands
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Recruitment postcode(s) [7]
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3001 - Tauranga, New Zealand
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Recruitment outside Australia
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Argentina
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Buenos Aires
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Argentina
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Bangkok
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Thailand
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Songkla
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Canakkale
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Turkey
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Gaziantep
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Mersin
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Newcastle
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Liverpool
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Windsor
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Venezuela
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Venezuela
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Estado Zulia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study compares indacaterol with tiotropium in terms of bronchodilation over 52 weeks
Query!
Trial website
https://clinicaltrials.gov/study/NCT00845728
Query!
Trial related presentations / 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.
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Public notes
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Contacts
Principal investigator
Name
0
0
Novartis Pharmaceuticals
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Address
0
0
Novartis Pharmaceuticals
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0
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0
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Fax
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Email
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Results are available at
https://clinicaltrials.gov/study/NCT00845728
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