Tags

Type your tag names separated by a space and hit enter

Comparison of a combination of tiotropium plus formoterol to salmeterol plus fluticasone in moderate COPD.
Chest. 2008 Aug; 134(2):255-262.Chest

Abstract

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 microg qd, plus formoterol, 12 microg bid, to salmeterol, 50 microg bid, plus fluticasone, 500 microg 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 FEV(1) area under the curve for the time period 0 to 12 h (AUC(0-12)) and peak FEV(1).

RESULTS

A total of 729 patients were screened, and 605 patients were randomized and treated. A total of 592 patients (baseline FEV(1), 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 FEV(1) AUC(0-12), 78 mL [p = 0.0006]; mean difference in FVC AUC(0-12), 173 mL, p < 0.0001). Also, peak responses were in favor of tiotropium plus formoterol (difference in peak FEV(1), 103 mL [p < 0.0001]; difference in peak FVC, 214 mL [p < 0.0001]), as were FEV(1) and FVC at each individual time point after dose (p < 0.05). Predose FVC was significantly higher with the bronchodilator combination, while predose FEV(1) 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.

Authors+Show Affiliations

Department of Pulmonology, Leiden University Medical Center, Leiden, the Netherlands. Electronic address: k.f.rabe@lumc.nl.Boehringer Ingelheim Pharma, Ingelheim, Germany.Boehringer Ingelheim Pharma, Ingelheim, Germany.Boehringer Ingelheim Pharma, Ingelheim, Germany.

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

18403672

Citation

Rabe, Klaus F., et al. "Comparison of a Combination of Tiotropium Plus Formoterol to Salmeterol Plus Fluticasone in Moderate COPD." Chest, vol. 134, no. 2, 2008, pp. 255-262.
Rabe KF, Timmer W, Sagkriotis A, et al. Comparison of a combination of tiotropium plus formoterol to salmeterol plus fluticasone in moderate COPD. Chest. 2008;134(2):255-262.
Rabe, K. F., Timmer, W., Sagkriotis, A., & Viel, K. (2008). Comparison of a combination of tiotropium plus formoterol to salmeterol plus fluticasone in moderate COPD. Chest, 134(2), 255-262. https://doi.org/10.1378/chest.07-2138
Rabe KF, et al. Comparison of a Combination of Tiotropium Plus Formoterol to Salmeterol Plus Fluticasone in Moderate COPD. Chest. 2008;134(2):255-262. PubMed PMID: 18403672.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparison of a combination of tiotropium plus formoterol to salmeterol plus fluticasone in moderate COPD. AU - Rabe,Klaus F, AU - Timmer,Wolfgang, AU - Sagkriotis,Alexandros, AU - Viel,Klaus, Y1 - 2008/04/10/ PY - 2008/4/12/pubmed PY - 2008/10/10/medline PY - 2008/4/12/entrez SP - 255 EP - 262 JF - Chest JO - Chest VL - 134 IS - 2 N2 - 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 microg qd, plus formoterol, 12 microg bid, to salmeterol, 50 microg bid, plus fluticasone, 500 microg 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 FEV(1) area under the curve for the time period 0 to 12 h (AUC(0-12)) and peak FEV(1). RESULTS: A total of 729 patients were screened, and 605 patients were randomized and treated. A total of 592 patients (baseline FEV(1), 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 FEV(1) AUC(0-12), 78 mL [p = 0.0006]; mean difference in FVC AUC(0-12), 173 mL, p < 0.0001). Also, peak responses were in favor of tiotropium plus formoterol (difference in peak FEV(1), 103 mL [p < 0.0001]; difference in peak FVC, 214 mL [p < 0.0001]), as were FEV(1) and FVC at each individual time point after dose (p < 0.05). Predose FVC was significantly higher with the bronchodilator combination, while predose FEV(1) 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. SN - 0012-3692 UR - https://www.unboundmedicine.com/medline/citation/18403672/Comparison_of_a_combination_of_tiotropium_plus_formoterol_to_salmeterol_plus_fluticasone_in_moderate_COPD_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0012-3692(08)60196-8 DB - PRIME DP - Unbound Medicine ER -