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: April 17, 2012

Last verified: April 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

March 11, 2011

Last Updated Date

April 17, 2012

Start Date ^ICMJE

March 2011

Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01315249 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Chronic Obstructive Pulmonary Disease (COPD)

Intervention ^ICMJE

Drug: QVA149
Drug: fluticasone/salmeterol

Study Arm (s)

Experimental: QVA149
QVA149, delivered once daily via single-dose dry powder inhaler (SDDPI)

Intervention: Drug: QVA149
Active Comparator: fluticasone/salmeterol (Seretide)
fluticasone/salmeterol (Seretide®) delivered twice daily via the Accuhaler®

Intervention: Drug: fluticasone/salmeterol

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

523

Completion Date

Not Provided

Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

40 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium, Czech Republic, Estonia, Germany, Hungary, Lithuania, Norway

Administrative Information

NCT Number ^ICMJE

NCT01315249

Other Study ID Numbers ^ICMJE

CQVA149A2313, 2010-023621-37

Has Data Monitoring Committee

Not Provided

Responsible Party

Novartis ( Novartis Pharmaceuticals )

Study Sponsor ^ICMJE

Novartis Pharmaceuticals

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Novartis Pharmaceuticals

Information Provided By

Novartis

Verification Date

April 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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