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


  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
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).
Total Total of all reporting groups

Baseline Measures
    QVA149     Fluticasone/Salmeterol     Total  
Number of Participants  
[units: participants]
  258     264     522  
Age  
[units: years]
Mean ± Standard Deviation
  63.2  ± 8.16     63.4  ± 7.71     63.3  ± 7.93  
Gender  
[units: participants]
     
Female     77     75     152  
Male     181     189     370  



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

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


  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
phone: 41 61 324 1111


No publications provided


Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01315249     History of Changes
Other Study ID Numbers: CQVA149A2313, 2010-023621-37
Study First Received: March 11, 2011
Results First Received: February 28, 2013
Last Updated: July 9, 2013
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Institutional Review Board
Belgium: Ministry of Social Affairs, Public Health and the Environment
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
Estonia: The State Agency of Medicine
Hungary: National Institute of Pharmacy
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Germany: Federal Ministry of Education and Research
Germany: Federal Ministry of Food, Agriculture and Consumer Protection
Germany: German Institute of Medical Documentation and Information
Germany: Ministry of Health
Germany: Paul-Ehrlich-Institut
Korea: Food and Drug Administration
Lithuania: Bioethics Committee
Lithuania: State Medicine Control Agency - Ministry of Health
South Korea: Institutional Review Board
South Korea: Korea Food and Drug Administration (KFDA)
Norway: Data Protection Authority
Norway: Directorate of Health
Norway: Norwegian Institute of Public Health
Norway: Norwegian Medicines Agency
Norway: Norwegian Social Science Data Services
Norway:National Committee for Medical and Health Research Ethics
Spain: Comité Ético de Investigación Clínica
Spain: Ethics Committee
Spain: Ministry of Health
Spain: Ministry of Health and Consumption
Spain: Spanish Agency of Medicines