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Efficacy and tolerability of budesonide/formoterol added to tiotropium in patients with chronic obstructive pulmonary disease.
Am J Respir Crit Care Med. 2009 Oct 15; 180(8):741-50.AJ

Abstract

RATIONALE

Budesonide/formoterol and tiotropium are commonly used maintenance treatments for patients with chronic obstructive pulmonary disease. Combining these medications may provide additional benefits.

OBJECTIVES

To assess the efficacy and tolerability of budesonide/formoterol added to tiotropium in patients eligible for inhaled corticosteroid/long-acting beta(2)-agonist combination therapy.

METHODS

In this 12-week, randomized, double-blind, parallel-group, multicenter study, after a 2-week run-in, 660 subjects (75% male; mean age, 62 yr; FEV(1), 1.1 L; 38% predicted normal), 40 years of age or older, received tiotropium (18 microg once daily) plus either budesonide/formoterol (320/9 microg) (n = 329) or placebo (n = 331) twice daily.

MEASUREMENTS AND MAIN RESULTS

Clinic predose (primary outcome) and postdose FEV(1), predose and postdose forced vital capacity and inspiratory capacity, and health status were measured. Other outcomes included daily measurements taken at home (pre- and postdose morning FEV(1) and peak expiratory flow, morning symptoms and activities, and morning reliever use), severe exacerbations, and tolerability. Over the treatment period, budesonide/formoterol plus tiotropium significantly increased predose FEV(1) by 6% (65 ml) and postdose by 11% (123 and 131 ml at 5 and 60 min postdose, respectively) versus tiotropium alone (both P < 0.001). Other outcomes all significantly improved with budesonide/formoterol plus tiotropium versus tiotropium alone. The number of severe exacerbations decreased by 62% (rate ratio, 0.38; 95% confidence interval, 0.25-0.57; P < 0.001). Both treatments were well tolerated.

CONCLUSIONS

In patients with chronic obstructive pulmonary disease, budesonide/formoterol added to tiotropium versus tiotropium alone provides rapid and sustained improvements in lung function, health status, morning symptoms and activities, and reduces severe exacerbations. Clinical trial registered with www.clinicaltrials.gov (NCT00496470).

Authors+Show Affiliations

Department of Respiratory Medicine, Hannover Medical School, Hannover, Germany. Welte.Tobias@MH-Hannover.DENo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

19644045

Citation

Welte, Tobias, et al. "Efficacy and Tolerability of Budesonide/formoterol Added to Tiotropium in Patients With Chronic Obstructive Pulmonary Disease." American Journal of Respiratory and Critical Care Medicine, vol. 180, no. 8, 2009, pp. 741-50.
Welte T, Miravitlles M, Hernandez P, et al. Efficacy and tolerability of budesonide/formoterol added to tiotropium in patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2009;180(8):741-50.
Welte, T., Miravitlles, M., Hernandez, P., Eriksson, G., Peterson, S., Polanowski, T., & Kessler, R. (2009). Efficacy and tolerability of budesonide/formoterol added to tiotropium in patients with chronic obstructive pulmonary disease. American Journal of Respiratory and Critical Care Medicine, 180(8), 741-50. https://doi.org/10.1164/rccm.200904-0492OC
Welte T, et al. Efficacy and Tolerability of Budesonide/formoterol Added to Tiotropium in Patients With Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2009 Oct 15;180(8):741-50. PubMed PMID: 19644045.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy and tolerability of budesonide/formoterol added to tiotropium in patients with chronic obstructive pulmonary disease. AU - Welte,Tobias, AU - Miravitlles,Marc, AU - Hernandez,Paul, AU - Eriksson,Göran, AU - Peterson,Stefan, AU - Polanowski,Tomasz, AU - Kessler,Romain, Y1 - 2009/07/30/ PY - 2009/8/1/entrez PY - 2009/8/1/pubmed PY - 2009/11/3/medline SP - 741 EP - 50 JF - American journal of respiratory and critical care medicine JO - Am. J. Respir. Crit. Care Med. VL - 180 IS - 8 N2 - RATIONALE: Budesonide/formoterol and tiotropium are commonly used maintenance treatments for patients with chronic obstructive pulmonary disease. Combining these medications may provide additional benefits. OBJECTIVES: To assess the efficacy and tolerability of budesonide/formoterol added to tiotropium in patients eligible for inhaled corticosteroid/long-acting beta(2)-agonist combination therapy. METHODS: In this 12-week, randomized, double-blind, parallel-group, multicenter study, after a 2-week run-in, 660 subjects (75% male; mean age, 62 yr; FEV(1), 1.1 L; 38% predicted normal), 40 years of age or older, received tiotropium (18 microg once daily) plus either budesonide/formoterol (320/9 microg) (n = 329) or placebo (n = 331) twice daily. MEASUREMENTS AND MAIN RESULTS: Clinic predose (primary outcome) and postdose FEV(1), predose and postdose forced vital capacity and inspiratory capacity, and health status were measured. Other outcomes included daily measurements taken at home (pre- and postdose morning FEV(1) and peak expiratory flow, morning symptoms and activities, and morning reliever use), severe exacerbations, and tolerability. Over the treatment period, budesonide/formoterol plus tiotropium significantly increased predose FEV(1) by 6% (65 ml) and postdose by 11% (123 and 131 ml at 5 and 60 min postdose, respectively) versus tiotropium alone (both P < 0.001). Other outcomes all significantly improved with budesonide/formoterol plus tiotropium versus tiotropium alone. The number of severe exacerbations decreased by 62% (rate ratio, 0.38; 95% confidence interval, 0.25-0.57; P < 0.001). Both treatments were well tolerated. CONCLUSIONS: In patients with chronic obstructive pulmonary disease, budesonide/formoterol added to tiotropium versus tiotropium alone provides rapid and sustained improvements in lung function, health status, morning symptoms and activities, and reduces severe exacerbations. Clinical trial registered with www.clinicaltrials.gov (NCT00496470). SN - 1535-4970 UR - https://www.unboundmedicine.com/medline/citation/19644045/Efficacy_and_tolerability_of_budesonide/formoterol_added_to_tiotropium_in_patients_with_chronic_obstructive_pulmonary_disease_ L2 - http://www.atsjournals.org/doi/full/10.1164/rccm.200904-0492OC?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -