0
Original Research: ASTHMA |

Formoterol, 24 μg bid, and Serious Asthma Exacerbations*: Similar Rates Compared With Formoterol, 12 μg bid, With and Without Extra Doses Taken on Demand, and Placebo

James Wolfe, MD, FCCP; Craig LaForce, MD; Bruce Friedman, MD; William Sokol, MD; Denise Till, MSc; Giovanni Della Cioppa, MD; Andre van As, MD, PhD, FCCP
Author and Funding Information

*From Allergy and Asthma Associates of Santa Clara Valley Research Center (Dr. Wolfe), San Jose, CA; North Carolina Clinical Research (Dr. LaForce), Raleigh, NC; Allergy, Asthma, Bronchitis and Immunology Associates (Dr. Friedman), Fountain Valley, CA; Health Research Institute (Dr. Sokol), Newport Beach, CA; Novartis Horsham Research Centre (Ms. Till and Dr. Della Cioppa), Horsham, UK; and Novartis Pharmaceuticals (Dr. van As), East Hanover, NJ.

Correspondence to: James Wolfe, MD, Allergy and Asthma Associates of Santa Clara Valley Research Center, 4050 Moorpark Ave, San Jose, CA 95117; e-mail: aaascv@asthmaresearch.com



Chest. 2006;129(1):27-38. doi:10.1378/chest.129.1.27
Text Size: A A A
Published online

Study objectives: The primary objective was to determine whether high-dose formoterol, 24 μg bid, was associated with more asthma exacerbations compared with lower formoterol doses in patients with stable persistent asthma. Serious asthma exacerbations (life threatening or requiring hospitalization) were the primary end point. Secondary end points included significant exacerbations requiring systemic corticosteroids, all exacerbations, and changes in FEV1.

Design: In a multicenter, placebo-controlled, parallel-group study, patients were randomized to 16 weeks of treatment with formoterol, 24 μg bid; formoterol, 12 μg bid, with up to two additional 12-μg doses daily on demand for worsening symptoms (12 μg bid plus on demand); formoterol, 12 μg bid; or placebo. The formoterol 12-μg-bid plus on-demand regimen was administered open label, while the other three regimens were double blind.

Setting: Outpatient clinics.

Patients: A total of 2,085 patients aged ≥ 12 years with stable, persistent asthma were enrolled and treated; 65% (n = 1,347) received regular concomitant antiinflammatory therapy during the study.

Measurements and results: Nine patients had respiratory-related serious adverse events (SAEs) requiring hospitalization: two patients (0.4%) in the 24-μg-bid group; one patient (0.2%) in the 12-μg-bid plus on-demand group; five patients (0.9%) in the 12-μg-bid group; and one patient (0.2%) in the placebo group. All of these events were asthma related, except for two SAEs in the 12-μg-bid group that were later considered not to be asthma related by independent reviewers who were not associated with the conduct of the study. The proportions of patients with significant asthma exacerbations (requiring systemic corticosteroids) were similar in the 24-μg-bid group (6.3%, 33 of 527 patients), 12-μg-bid group (5.9%, 31 of 527 patients) and placebo group (8.8%, 45 of 514 patients) and lower in the 12-μg-bid plus on-demand group (4.4%, 23 of 517 patients; p = 0.0057 vs placebo). All treatments were well tolerated. All formoterol treatment regimens had a significant effect on FEV1 measured 2 h after dose during the study (p < 0.0001 vs placebo); and on predose trough FEV1 measured at all visits after baseline (p < 0.002 vs placebo).

Conclusions: Treatment with formoterol, 24 μg bid, was not associated with an increase in serious asthma exacerbations compared with the lower formoterol doses or placebo.

Figures in this Article

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.

CHEST Journal Articles
PubMed Articles
Vilanterol and fluticasone furoate for asthma. Cochrane Database Syst Rev Published online Sep 01, 2016;
Guidelines
Long-term management of asthma.
Finnish Medical Society Duodecim | 1/11/2008
  • CHEST Journal
    Print ISSN: 0012-3692
    Online ISSN: 1931-3543