Exacerbation Study (INVIGORATE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00845728
First received: February 15, 2009
Last updated: September 16, 2013
Last verified: September 2013
Results First Received: July 3, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Chronic Obstructive Pulmonary Disease
Interventions: Drug: Indacaterol 150 µg
Drug: Tiotropium

  Participant Flow
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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
No text entered.

Reporting Groups
  Description
Indacaterol

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
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Indacaterol

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
Total Total of all reporting groups

Baseline Measures
    Indacaterol     Tiotropium     Total  
Number of Participants  
[units: participants]
  1721     1718     3439  
Age, Customized  
[units: Participants]
     
<65 years     929     909     1838  
≥ 65 years     792     809     1601  
Gender  
[units: Participants]
     
Female     377     405     782  
Male     1344     1313     2657  



  Outcome Measures
  Show All 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


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


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
No text entered.  


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300


No publications provided


Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00845728     History of Changes
Other Study ID Numbers: CQAB149B2348, 2008-007944-33
Study First Received: February 15, 2009
Results First Received: July 3, 2013
Last Updated: September 16, 2013
Health Authority: United States: Food and Drug Administration
Austria: Federal Office for Safety in Health Care
Slovakia: State Institute for Drug Control
Canada: Health Canada
Israel: Ministry of Health
Spain: Spanish Agency of Medicines
Estonia: The State Agency of Medicine
Lithuania: State Medicine Control Agency - Ministry of Health
Finland: Finnish Medicines Agency
Belgium: Federal Agency for Medicinal Products and Health Products
United Kingdom: Medicines and Healthcare Products Regulatory Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
India: Drugs Controller General of India
Hungary: National Institute of Pharmacy
Iceland: Icelandic Medicines Control Agency
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Australia: Department of Health and Ageing Therapeutic Goods Administration
Denmark: Danish Medicines Agency
Czech Republic: State Institute for Drug Control
Turkey: Ministry of Health
Latvia: State Agency of Medicines
Philippines: Bureau of Food and Drugs
Russia: FSI Scientific Center of Expertise of Medical Application
Germany: Federal Institute for Drugs and Medical Devices
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Portugal: National Authority of Medicines and Health Products (INFARMED, I.P.)
Taiwan: Department of Health
Sweden: Medical Products Agency
Switzerland: Swissmedic
Romania: National Medicines Agency
Peru: Instituto Nacional de Salud
Costa Rica: Ministry of Health Costa Rica
Italy: The Italian Medicines Agency
South Africa: Medicines Control Council
China: Food and Drug Administration
Venezuela: Ministry of Health and Social Development
Brazil: National Health Surveillance Agency
Thailand: Food and Drug Administration
Mexico: National Institute of Public Health, Health Secretariat
New Zealand: Ministry of Health