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QVA149 Versus Fluticasone/Salmeterol in Patients With Chronic Obstructive Pulmonary Disease (COPD) (ILLUMINATE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01315249
First received: March 11, 2011
Last updated: July 9, 2013
Last verified: July 2013
Results First Received: February 28, 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 (COPD)
Interventions: Drug: indacaterol and glycopyrronium (QVA149)
Drug: Placebo to fluticasone/salmeterol
Drug: fluticasone/salmeterol
Drug: Placebo to indacaterol and glycopyrronium (QVA149)

  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
All eligible patients were randomized to one of the 2 arms in a 1:1 ratio for 26 weeks of treatment.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 523 patients were randomized. A total of 522 patients (99.8%) were included in the Full analysis Set (FAS) and Safety set. One patient was excluded who was randomized in error and did not receive study medication.

Reporting Groups
  Description
QVA149 Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
Fluticasone/Salmeterol Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).

Participant Flow:   Overall Study
    QVA149     Fluticasone/Salmeterol  
STARTED     259     264  
COMPLETED     215     217  
NOT COMPLETED     44     47  
Adverse Event                 22                 26  
Withdrawal by Subject                 11                 10  
Protocol Violation                 8                 5  
Abnormal test results                 1                 2  
Administrative problems                 1                 0  
inability to use device                 1                 0  
Lack of Efficacy                 0                 1  
Lost to Follow-up                 0                 2  
Death                 0                 1  



  Baseline Characteristics


  Outcome Measures
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1.  Primary:   Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12   [ Time Frame: Week 26 ]

2.  Secondary:   Standardized Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12 Hours   [ Time Frame: Week 12 ]

3.  Secondary:   Forced Vital Capacity at All-time Points (Week 12)   [ Time Frame: -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 12 ]

4.  Secondary:   Forced Vital Capacity at All-time Points (Week 26)   [ Time Frame: -45 min, -15 min predose; 5 min, 30 min, 1 hr, 2hr, 4 hr, 8 hr, 12 hr post-dose on week 26 ]

5.  Secondary:   Focal Score of the Transitional Dyspnea Index (TDI)   [ Time Frame: 12 weeks and 26 weeks ]

6.  Secondary:   Total Score of the St. George's Respiratory Questionnaire (SGRQ-C)   [ Time Frame: 12 weeks and 26 weeks ]

7.  Secondary:   Mean Change From Baseline in Daily Number of Puffs of Rescue Medication   [ Time Frame: Baseline, 12 weeks and 26 weeks ]

8.  Secondary:   Change From Baseline in Symptom Scores Reported Using the Ediary   [ Time Frame: 12 weeks and 26 weeks ]

9.  Secondary:   Inspiratory Capacity (IC) at All-time Points (12 Weeks)   [ Time Frame: 12 weeks ]

10.  Secondary:   Inspiratory Capacity (IC) at All-time Points (26 Weeks)   [ Time Frame: 26 weeks ]

11.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: 26 weeks ]


  Serious Adverse Events
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Reporting Groups
  Description
QVA149 Participants received indacaterol and glycopyrronium (QVA149) and placebo to fluticasone/salmeterol.
Fluticasone/Salmeterol Participants received fluticasone/salmeterol and placebo to indacaterol and glycopyrronium (QVA149).

Serious Adverse Events
    QVA149     Fluticasone/Salmeterol  
Total, serious adverse events      
# participants affected / at risk     13/258 (5.04%)     14/264 (5.30%)  
Cardiac disorders      
Acute coronary syndrome † 1    
# participants affected / at risk     0/258 (0.00%)     1/264 (0.38%)  
Acute myocardial infarction † 1    
# participants affected / at risk     1/258 (0.39%)     0/264 (0.00%)  
Angina pectoris † 1    
# participants affected / at risk     1/258 (0.39%)     0/264 (0.00%)  
Atrial fibrillation † 1    
# participants affected / at risk     1/258 (0.39%)     0/264 (0.00%)  
Coronary artery stenosis † 1    
# participants affected / at risk     1/258 (0.39%)     0/264 (0.00%)  
Gastrointestinal disorders      
Dyspepsia † 1    
# participants affected / at risk     1/258 (0.39%)     0/264 (0.00%)  
Dysphagia † 1    
# participants affected / at risk     1/258 (0.39%)     0/264 (0.00%)  
Infections and infestations      
Abscess limb † 1    
# participants affected / at risk     0/258 (0.00%)     1/264 (0.38%)  
Bronchitis † 1    
# participants affected / at risk     0/258 (0.00%)     1/264 (0.38%)  
Nasopharyngitis † 1    
# participants affected / at risk     0/258 (0.00%)     1/264 (0.38%)  
Pneumonia † 1    
# participants affected / at risk     0/258 (0.00%)     2/264 (0.76%)  
Injury, poisoning and procedural complications      
Contusion † 1    
# participants affected / at risk     1/258 (0.39%)     0/264 (0.00%)  
Metabolism and nutrition disorders      
Diabetes mellitus † 1    
# participants affected / at risk     1/258 (0.39%)     0/264 (0.00%)  
Musculoskeletal and connective tissue disorders      
Myopathy † 1    
# participants affected / at risk     1/258 (0.39%)     0/264 (0.00%)  
Neoplasms benign, malignant and unspecified (incl cysts and polyps)      
Colon cancer † 1    
# participants affected / at risk     0/258 (0.00%)     1/264 (0.38%)  
Lung adenocarcinoma † 1    
# participants affected / at risk     0/258 (0.00%)     1/264 (0.38%)  
Oesophageal carcinoma † 1    
# participants affected / at risk     1/258 (0.39%)     0/264 (0.00%)  
Rectal cancer † 1    
# participants affected / at risk     1/258 (0.39%)     0/264 (0.00%)  
Small cell lung cancer stage unspecified † 1    
# participants affected / at risk     0/258 (0.00%)     1/264 (0.38%)  
Nervous system disorders      
Carotid artery occlusion † 1    
# participants affected / at risk     0/258 (0.00%)     1/264 (0.38%)  
Carotid artery stenosis † 1    
# participants affected / at risk     1/258 (0.39%)     0/264 (0.00%)  
Ischaemic stroke † 1    
# participants affected / at risk     0/258 (0.00%)     1/264 (0.38%)  
Reproductive system and breast disorders      
Benign prostatic hyperplasia † 1    
# participants affected / at risk     1/258 (0.39%)     0/264 (0.00%)  
Epididymitis † 1    
# participants affected / at risk     0/258 (0.00%)     1/264 (0.38%)  
Respiratory, thoracic and mediastinal disorders      
Acute respiratory failure † 1    
# participants affected / at risk     1/258 (0.39%)     0/264 (0.00%)  
Chronic obstructive pulmonary disease † 1    
# participants affected / at risk     1/258 (0.39%)     3/264 (1.14%)  
Dyspnoea † 1    
# participants affected / at risk     1/258 (0.39%)     0/264 (0.00%)  
Pleural effusion † 1    
# participants affected / at risk     1/258 (0.39%)     1/264 (0.38%)  
Skin and subcutaneous tissue disorders      
Skin ulcer † 1    
# participants affected / at risk     0/258 (0.00%)     1/264 (0.38%)  
Vascular disorders      
Peripheral artery aneurysm † 1    
# participants affected / at risk     0/258 (0.00%)     1/264 (0.38%)  
Venous insufficiency † 1    
# participants affected / at risk     0/258 (0.00%)     1/264 (0.38%)  
Venous thrombosis limb † 1    
# participants affected / at risk     1/258 (0.39%)     0/264 (0.00%)  
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA




  Other Adverse Events


  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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