0
Original Research: COPD |

Comparison of a Combination of Tiotropium Plus Formoterol to Salmeterol Plus Fluticasone in Moderate COPD*

Klaus F. Rabe, PhD, MD; Wolfgang Timmer, MD; Alexandros Sagkriotis, MSc; Klaus Viel, MD
Author and Funding Information

*From the Department of Pulmonology (Dr. Rabe), Leiden University Medical Center, Leiden, the Netherlands; and Boehringer Ingelheim Pharma (Drs. Timmer and Viel, and Mr. Sagkriotis), Ingelheim, Germany.

Correspondence to: Klaus F. Rabe, PhD, MD, Department of Pulmonology C3-P, Leiden University Medical Center, Albinus-dreef 2 Postbus, NL-2300 Leiden, the Netherlands; e-mail: k.f.rabe@lumc.nl



Chest. 2008;134(2):255-262. doi:10.1378/chest.07-2138
Text Size: A A A
Published online

Background: A 6-week, multicenter, randomized, double-blind, parallel-group study was conducted in patients with COPD to compare lung function improvements of tiotropium, 18 μg qd, plus formoterol, 12 μg bid, to salmeterol, 50 μg bid, plus fluticasone, 500 μg bid.

Methods: Following a screening visit, subjects entered a run-in period in which they received regular ipratropium. At randomization, patients were assigned to either tiotropium plus formoterol or salmeterol plus fluticasone. After 6 weeks of treatment, a 12-h lung function profile was obtained. The coprimary end points were FEV1 area under the curve for the time period 0 to 12 h (AUC0–12) and peak FEV1.

Results: A total of 729 patients were screened, and 605 patients were randomized and treated. A total of 592 patients (baseline FEV1, 1.32 ± 0.43 L/min [±SD]) were included in the analysis. After 6 weeks, the 12-h lung function profiles in the group receiving tiotropium plus formoterol were superior to those in the group receiving salmeterol plus fluticasone (mean difference in FEV1 AUC0–12, 78 mL [p = 0.0006]; mean difference in FVC AUC0–12, 173 mL, p < 0.0001). Also, peak responses were in favor of tiotropium plus formoterol (difference in peak FEV1, 103 mL [p < 0.0001]; difference in peak FVC, 214 mL [p < 0.0001]), as were FEV1 and FVC at each individual time point after dose (p < 0.05). Predose FVC was significantly higher with the bronchodilator combination, while predose FEV1 and rescue medication use did not differ significantly between groups. Both treatments were well tolerated.

Conclusions: Tiotropium plus formoterol was superior in lung function over the day compared to salmeterol plus fluticasone in patients with moderate COPD. Long-term studies in patients with severe COPD are warranted to assess the relative efficacy of different treatment combinations.

Trial registration: Clinicaltrials.gov Identifier: NCT00239421.

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.

Find Similar Articles
CHEST Journal Articles
  • CHEST Journal
    Print ISSN: 0012-3692
    Online ISSN: 1931-3543