0
Obstructive Lung Diseases |

Once-Daily Dual Bronchodilation With QVA149 Reduces COPD Exacerbations: Results From the IGNITE Program

Donald Banerji, MD; Mark Fedele, PhD; Hungta Chen, PhD
Author and Funding Information

Novartis Pharmaceuticals Corporation, East Hanover, NJ


Chest. 2014;145(3_MeetingAbstracts):403A. doi:10.1378/chest.1824292
Text Size: A A A
Published online

Abstract

SESSION TITLE: COPD QVA149 Posters

SESSION TYPE: Poster Presentations

PRESENTED ON: Saturday, March 22, 2014 at 01:15 PM - 02:15 PM

PURPOSE: Combined use of long-acting bronchodilators with different mechanism of action optimizes bronchodilation and may reduce the risk of exacerbations. QVA149 is a novel dual bronchodilator containing a fixed-dose combination of the long-acting β2-agonist (LABA) indacaterol and long-acting muscarinic antagonist (LAMA) glycopyrronium (NVA237) for the maintenance treatment of COPD. Here, we report findings from the SPARK and ILLUMINATE studies of the IGNITE program, with a focus on the rate and prevention of exacerbations.

METHODS: Both SPARK and ILLUMINATE were multicenter, double-blind, randomized studies with treatment durations of 64 and 26 weeks, respectively. Patients (aged ≥40years) with severe-to-very severe COPD and a history of exacerbations were randomized to once-daily QVA149 (110/50μg), glycopyrronium (50μg), or open-label tiotropium 18μg (1:1:1) in the SPARK study. In the ILLUMINATE study, patients (aged ≥40years) with moderate-to-severe COPD with no history of exacerbations were randomized to once-daily QVA149 110/50μg or twice-daily salmeterol/fluticasone combination (SFC) 50/500μg (1:1).

RESULTS: SPARK and ILLUMINATE randomized 2224 (75% completed) and 523 (83% completed) patients, respectively. In the SPARK study, QVA149 significantly reduced the rate of all (mild, moderate and severe) exacerbations by 15% versus glycopyrronium (Rate Ratio [RR] 0.85; 95% confidence interval [CI] 0.77-0.94; p=0.001) and 14% versus tiotropium (RR 0.86; 95% CI 0.78-0.94; p=0.002). In the ILLUMINATE study, QVA149 reduced the rate of all exacerbations by 31% versus SFC (RR 0.69; 95% CI 0.44-1.07; p=0.098). Furthermore, QVA149 reduced the risk of time to first exacerbation by 35% versus SFC (hazard ratio 0.65; 95% CI 0.44-0.96; p=0.03) in the ILLUMINATE study.

CONCLUSIONS: QVA149 reduced the rate of exacerbations compared with glycopyrronium and tiotropium, and delayed the time to first exacerbation compared with salmeterol/fluticasone combination.

CLINICAL IMPLICATIONS: The results suggest the potential of QVA149 for reducing exacerbations compared to current standard of care (LAMA or LABA/inhaled corticosteroids), irrespective of patients having a history of exacerbations.

DISCLOSURE: Donald Banerji: Employee: Novartis Employee Mark Fedele: Employee: Novartis Employee Hungta Chen: Employee: Novartis Employee

Clinical trial results of QVA149, combination of approved products indacaterol and glycopyrronium, will be presented, QVA149 is in the late stage phase 3 trials prior to approval.


Sign In to Access Full Content

MEMBER & INDIVIDUAL SUBSCRIBER

Want Access?

NEW TO CHEST?

Become a CHEST member and receive a FREE subscription as a benefit of membership.

Individuals can purchase this article on ScienceDirect.

Individuals can purchase a subscription to the journal.

Individuals can purchase a subscription to the journal or buy individual articles.

Learn more about membership or Purchase a Full Subscription.

INSTITUTIONAL ACCESS

Institutional access is now available through ScienceDirect and can be purchased at myelsevier.com.

Sign In to Access Full Content

MEMBER & INDIVIDUAL SUBSCRIBER

Want Access?

NEW TO CHEST?

Become a CHEST member and receive a FREE subscription as a benefit of membership.

Individuals can purchase this article on ScienceDirect.

Individuals can purchase a subscription to the journal.

Individuals can purchase a subscription to the journal or buy individual articles.

Learn more about membership or Purchase a Full Subscription.

INSTITUTIONAL ACCESS

Institutional access is now available through ScienceDirect and can be purchased at myelsevier.com.

Figures

Tables

References

NOTE:
Citing articles are presented as examples only. In non-demo SCM6 implementation, integration with CrossRef’s "Cited By" API will populate this tab (http://www.crossref.org/citedby.html).

Some tools below are only available to our subscribers or users with an online account.

Sign In to Access Full Content

MEMBER & INDIVIDUAL SUBSCRIBER

Want Access?

NEW TO CHEST?

Become a CHEST member and receive a FREE subscription as a benefit of membership.

Individuals can purchase this article on ScienceDirect.

Individuals can purchase a subscription to the journal.

Individuals can purchase a subscription to the journal or buy individual articles.

Learn more about membership or Purchase a Full Subscription.

INSTITUTIONAL ACCESS

Institutional access is now available through ScienceDirect and can be purchased at myelsevier.com.

Related Content

Customize your page view by dragging & repositioning the boxes below.

Find Similar Articles
CHEST Journal Articles
PubMed Articles
Tiotropium: a new therapeutic option in asthma. Monaldi Arch Chest Dis ;79(3-4):109-15.
Dual therapy strategies for COPD: the scientific rationale for LAMA + LABA. Int J Chron Obstruct Pulmon Dis 2016;11():785-97.
  • CHEST Journal
    Print ISSN: 0012-3692
    Online ISSN: 1931-3543