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Concomitant treatment with nebulized formoterol and tiotropium in subjects with COPD: a placebo-controlled trial.
Respir Med. 2008 Apr; 102(4):479-87.RM

Abstract

Adding a long-acting beta(2)-agonist (LABA) by dry powder inhaler (DPI) to tiotropium provides significantly increased and sustained bronchodilation in chronic obstructive pulmonary disease (COPD) patients over either product alone. To demonstrate similar benefits with a nebulized LABA, a placebo-controlled trial was conducted to evaluate the efficacy and safety of formoterol fumarate inhalation solution in subjects receiving tiotropium as a maintenance treatment for COPD. After a 7-14-day screening period using tiotropium 18 microg once daily, subjects with diagnosed COPD (> or = 25% to <65% predicted FEV(1)) were randomized to receive 20 microg formoterol fumarate inhalation solution twice daily for nebulization plus tiotropium (FFIS/TIO) or nebulized placebo twice daily plus tiotropium (PLA/TIO) for 6 weeks. Efficacy was assessed with spirometry at each visit (Day 1, Week 1, 3, 6), the transition dyspnea index (TDI), and St. George's Respiratory Questionnaire (SGRQ). Baseline characteristics were comparable, including mean FEV(1)% predicted. At Week 6, FEV(1) AUC(0-3) was 1.52 L for FFIS/TIO-treated subjects vs. 1.34 L for PLA/TIO-treated subjects (p<0.0001). The mean TDI scores in the FFIS/TIO and PLA/TIO groups were 2.30 and 0.16, respectively (p=0.0002). SGRQ did not change significantly with 6 weeks treatment, with the exception of FFIS/TIO improvements in symptom score vs. PLA/TIO (p=0.04). More PLA/TIO- than FFIS/TIO-treated subjects experienced AEs (39.7% vs. 22.9%), COPD exacerbations (7.9% vs. 4.5%), and serious AEs (3.2% vs. 1.5%). Nebulized formoterol fumarate in combination with tiotropium provided statistically and clinically significant improvements in bronchodilation and symptom control over tiotropium alone and demonstrated good tolerability.

Authors+Show Affiliations

Division of Pulmonary and Critical Care Medicine, David Geffen School of Medicine at UCLA, Los Angeles, CA 90095, USA. dtashkin@mednet.ucla.eduNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

18258423

Citation

Tashkin, Donald P., et al. "Concomitant Treatment With Nebulized Formoterol and Tiotropium in Subjects With COPD: a Placebo-controlled Trial." Respiratory Medicine, vol. 102, no. 4, 2008, pp. 479-87.
Tashkin DP, Littner M, Andrews CP, et al. Concomitant treatment with nebulized formoterol and tiotropium in subjects with COPD: a placebo-controlled trial. Respir Med. 2008;102(4):479-87.
Tashkin, D. P., Littner, M., Andrews, C. P., Tomlinson, L., Rinehart, M., & Denis-Mize, K. (2008). Concomitant treatment with nebulized formoterol and tiotropium in subjects with COPD: a placebo-controlled trial. Respiratory Medicine, 102(4), 479-87. https://doi.org/10.1016/j.rmed.2007.12.019
Tashkin DP, et al. Concomitant Treatment With Nebulized Formoterol and Tiotropium in Subjects With COPD: a Placebo-controlled Trial. Respir Med. 2008;102(4):479-87. PubMed PMID: 18258423.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Concomitant treatment with nebulized formoterol and tiotropium in subjects with COPD: a placebo-controlled trial. AU - Tashkin,Donald P, AU - Littner,Michael, AU - Andrews,Charles P, AU - Tomlinson,LaTanya, AU - Rinehart,Mike, AU - Denis-Mize,Kimberly, Y1 - 2008/02/06/ PY - 2007/10/17/received PY - 2007/12/18/revised PY - 2007/12/19/accepted PY - 2008/2/9/pubmed PY - 2008/10/1/medline PY - 2008/2/9/entrez SP - 479 EP - 87 JF - Respiratory medicine JO - Respir Med VL - 102 IS - 4 N2 - Adding a long-acting beta(2)-agonist (LABA) by dry powder inhaler (DPI) to tiotropium provides significantly increased and sustained bronchodilation in chronic obstructive pulmonary disease (COPD) patients over either product alone. To demonstrate similar benefits with a nebulized LABA, a placebo-controlled trial was conducted to evaluate the efficacy and safety of formoterol fumarate inhalation solution in subjects receiving tiotropium as a maintenance treatment for COPD. After a 7-14-day screening period using tiotropium 18 microg once daily, subjects with diagnosed COPD (> or = 25% to <65% predicted FEV(1)) were randomized to receive 20 microg formoterol fumarate inhalation solution twice daily for nebulization plus tiotropium (FFIS/TIO) or nebulized placebo twice daily plus tiotropium (PLA/TIO) for 6 weeks. Efficacy was assessed with spirometry at each visit (Day 1, Week 1, 3, 6), the transition dyspnea index (TDI), and St. George's Respiratory Questionnaire (SGRQ). Baseline characteristics were comparable, including mean FEV(1)% predicted. At Week 6, FEV(1) AUC(0-3) was 1.52 L for FFIS/TIO-treated subjects vs. 1.34 L for PLA/TIO-treated subjects (p<0.0001). The mean TDI scores in the FFIS/TIO and PLA/TIO groups were 2.30 and 0.16, respectively (p=0.0002). SGRQ did not change significantly with 6 weeks treatment, with the exception of FFIS/TIO improvements in symptom score vs. PLA/TIO (p=0.04). More PLA/TIO- than FFIS/TIO-treated subjects experienced AEs (39.7% vs. 22.9%), COPD exacerbations (7.9% vs. 4.5%), and serious AEs (3.2% vs. 1.5%). Nebulized formoterol fumarate in combination with tiotropium provided statistically and clinically significant improvements in bronchodilation and symptom control over tiotropium alone and demonstrated good tolerability. SN - 0954-6111 UR - https://www.unboundmedicine.com/medline/citation/18258423/Concomitant_treatment_with_nebulized_formoterol_and_tiotropium_in_subjects_with_COPD:_a_placebo_controlled_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0954-6111(08)00004-8 DB - PRIME DP - Unbound Medicine ER -