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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 
Overall Participants Analyzed 
[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 (51.71%)   793/1718 (46.16%) 
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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