Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
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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
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   1.5%  

Reporting Groups
  Description
IndIndacaterol 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

Other Adverse Events
    IndIndacaterol     Tiotropium  
Total, other (not including serious) adverse events      
# participants affected / at risk     890/1721     793/1718  
Gastrointestinal disorders      
Diarrhoea † 1    
# participants affected / at risk     26/1721 (1.51%)     43/1718 (2.50%)  
General disorders      
Pyrexia † 1    
# participants affected / at risk     19/1721 (1.10%)     26/1718 (1.51%)  
Infections and infestations      
Bronchitis † 1    
# participants affected / at risk     39/1721 (2.27%)     34/1718 (1.98%)  
Influenza † 1    
# participants affected / at risk     38/1721 (2.21%)     45/1718 (2.62%)  
Lower respiratory tract infection † 1    
# participants affected / at risk     125/1721 (7.26%)     98/1718 (5.70%)  
Nasopharyngitis † 1    
# participants affected / at risk     118/1721 (6.86%)     101/1718 (5.88%)  
Upper respiratory tract infection † 1    
# participants affected / at risk     70/1721 (4.07%)     63/1718 (3.67%)  
Upper respiratory tract infection bacterial † 1    
# participants affected / at risk     139/1721 (8.08%)     127/1718 (7.39%)  
Urinary tract infection † 1    
# participants affected / at risk     31/1721 (1.80%)     26/1718 (1.51%)  
Viral upper respiratory tract infection † 1    
# participants affected / at risk     91/1721 (5.29%)     65/1718 (3.78%)  
Musculoskeletal and connective tissue disorders      
Back pain † 1    
# participants affected / at risk     39/1721 (2.27%)     40/1718 (2.33%)  
Nervous system disorders      
Headache † 1    
# participants affected / at risk     53/1721 (3.08%)     49/1718 (2.85%)  
Respiratory, thoracic and mediastinal disorders      
Chronic obstructive pulmonary disease † 1    
# participants affected / at risk     668/1721 (38.81%)     591/1718 (34.40%)  
Cough † 1    
# participants affected / at risk     107/1721 (6.22%)     56/1718 (3.26%)  
Dyspnoea † 1    
# participants affected / at risk     56/1721 (3.25%)     50/1718 (2.91%)  
Vascular disorders      
Hypertension † 1    
# participants affected / at risk     63/1721 (3.66%)     48/1718 (2.79%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA



  Limitations and Caveats
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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
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  More Information