QVA149 Versus Fluticasone/Salmeterol in Patients With Chronic Obstructive Pulmonary Disease (COPD) (ILLUMINATE)
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01315249
First received: March 11, 2011
Last updated: April 17, 2012
Last verified: April 2012
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Purpose
The purpose of this study is to compare the efficacy and safety/tolerbility of QVA149 (fixed-dose combination of indacaterol and NVA237)with fluticasone/salmeterol over a 26-week period in patients with moderate to severe COPD.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Obstructive Pulmonary Disease (COPD) |
Drug: QVA149 Drug: fluticasone/salmeterol |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A 26-week Treatment, Multi-center, Randomized, Double-blind, Double Dummy, Parallel-group Study to Assess the Efficacy, Safety and Tolerability of QVA149 Compared to Fluticasone/Salmeterol in Patients With Moderate to Severe COPD |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- To demonstrate the superiority of once-daily QVA149 as compared to twice-daily fluticasone/salmeterol in terms of forced expiratory volume in one second (FEV1) area under the curve for 0-12 hours (AUC0-12h) in patients with moderate to severe COPD. [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To evaluate the effect of QVA149 as compared to fluticasone/salmeterol in terms of standardized FEV1 AUC0-12h. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- To evaluate the effect of QVA149 as compared to fluticasone/salmeterol in terms of safety and tolerability as measured by adverse events [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 523 |
| Study Start Date: | March 2011 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: QVA149
QVA149, delivered once daily via single-dose dry powder inhaler (SDDPI)
|
Drug: QVA149 |
|
Active Comparator: fluticasone/salmeterol (Seretide)
fluticasone/salmeterol (Seretide®) delivered twice daily via the Accuhaler®
|
Drug: fluticasone/salmeterol |
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Smoking history of at least 10 pack years
- Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD] Guidelines, 2009)
- Post-bronchodilator FEV1 < 80% and ≥ 40% of the predicted normal value and post-bronchodilator FEV1/FVC (forced vital capacity) <70%
Exclusion Criteria:
- Patients who have had a COPD exacerbation that required treatment with antibiotics, systemic steroids (oral or intravenous) or hospitalization in the last year.
- Patients requiring long term oxygen therapy on a daily basis for chronic hypoxemia.
- Patients who have had a respiratory tract infection within 4 weeks prior to Visit 1.
- Patients with concomitant pulmonary disease
- Patients with a history of asthma
- Any patient with lung cancer or a history of lung cancer
- Patients with a history of certain cardiovascular co-morbid conditions
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01315249
Show 69 Study Locations
Show 69 Study LocationsSponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
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 |
| Last Updated: | April 17, 2012 |
| Health Authority: | United States: Food and Drug Administration Belgium: Directorate general for the protection of Public health: Medicines 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: The National Committees for 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 |
Keywords provided by Novartis:
|
QVA149 indacaterol NVA237 COPD Fluticasone/Salmeterol |
Additional relevant MeSH terms:
|
Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases Salmeterol Albuterol Fluticasone Fluticasone, salmeterol drug combination Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Physiological Effects of Drugs Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Tocolytic Agents Reproductive Control Agents Dermatologic Agents Anti-Allergic Agents Anti-Inflammatory Agents Glucocorticoids Hormones |
ClinicalTrials.gov processed this record on May 16, 2013