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The effect of umeclidinium on lung function and symptoms in patients with fixed airflow obstruction and reversibility to salbutamol: A randomised, 3-phase study.
Respir Med 2017; 131:148-157RM

Abstract

INTRODUCTION

The long-acting muscarinic antagonist, umeclidinium (UMEC), combined with the inhaled corticosteroid, fluticasone furoate (FF), improves lung function in symptomatic patients with asthma. We assessed FF/UMEC in patients with a primary diagnosis of asthma or chronic obstructive pulmonary disease (COPD), but physiological characteristics of both (fixed airflow obstruction and reversibility to salbutamol).

METHODS

This double-blind, parallel-arm, 3-phase study randomised 338 patients (1:1:1:1:2:2) to FF 100 mcg alone or combined with UMEC (15.6, 62.5, 125, or 250 mcg) or vilanterol 25 mcg (Phase A, 4 weeks). Primary endpoint: change from baseline in clinic trough forced expiratory volume in 1 s (FEV1) (end of Phase A). Secondary endpoints: morning peak expiratory flow (PEF), rescue medication use and Evaluating Respiratory Symptoms in COPD (E-RS™: COPD) scores. Safety was assessed.

RESULTS

In the intent-to-treat population, the increase in trough FEV1 over FF was significant for FF/UMEC 62.5 (0.140 L [p = 0.019]) and 125 mcg (0.120 L [p = 0.039]), with similar changes for patients with a primary diagnosis of asthma or COPD. Changes from baseline in morning PEF and E-RS total score were greater for all FF/UMEC doses vs FF (p ≤ 0.05). Change from baseline in rescue medication use was statistically or clinically significant for all FF/UMEC doses vs FF. The incidence of on-treatment adverse events was 15%-32% (Phase A), with no dose-related effects.

CONCLUSIONS

FF/UMEC 62.5 mcg produced clinically meaningful improvements in FEV1, morning PEF, E-RS total score and rescue medication use. FF/UMEC may benefit patients with features of both asthma and COPD. CLINICALTRIALS.GOV: NCT02164539; GSK: 200699.

Authors+Show Affiliations

GSK, Gunnels Wood Rd, Stevenage, Hertfordshire SG1 2NY, UK. Electronic address: laurie.a.lee@gsk.com.Clinical Research Institute of Southern Oregon, PC, 3860 Crater Lake Ave, Medford, OR 97504, USA.GSK, 5 Moore Dr, Research Triangle Park, NC 27709, USA.GSK, 1250 S Collegeville Rd, Collegeville, PA 19426, USA.Biostatistics, PAREXEL International, 2520 Meridian Pkwy #200, Durham, NC 27713, USA.GSK, Stockley Park West, Uxbridge, Middlesex UB11 1BT, UK.GSK, 5 Moore Dr, Research Triangle Park, NC 27709, USA.

Pub Type(s)

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

Language

eng

PubMed ID

28947022

Citation

Lee, Laurie, et al. "The Effect of Umeclidinium On Lung Function and Symptoms in Patients With Fixed Airflow Obstruction and Reversibility to Salbutamol: a Randomised, 3-phase Study." Respiratory Medicine, vol. 131, 2017, pp. 148-157.
Lee L, Kerwin E, Collison K, et al. The effect of umeclidinium on lung function and symptoms in patients with fixed airflow obstruction and reversibility to salbutamol: A randomised, 3-phase study. Respir Med. 2017;131:148-157.
Lee, L., Kerwin, E., Collison, K., Nelsen, L., Wu, W., Yang, S., & Pascoe, S. (2017). The effect of umeclidinium on lung function and symptoms in patients with fixed airflow obstruction and reversibility to salbutamol: A randomised, 3-phase study. Respiratory Medicine, 131, pp. 148-157. doi:10.1016/j.rmed.2017.08.013.
Lee L, et al. The Effect of Umeclidinium On Lung Function and Symptoms in Patients With Fixed Airflow Obstruction and Reversibility to Salbutamol: a Randomised, 3-phase Study. Respir Med. 2017;131:148-157. PubMed PMID: 28947022.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The effect of umeclidinium on lung function and symptoms in patients with fixed airflow obstruction and reversibility to salbutamol: A randomised, 3-phase study. AU - Lee,Laurie, AU - Kerwin,Edward, AU - Collison,Kathryn, AU - Nelsen,Linda, AU - Wu,Wei, AU - Yang,Shuying, AU - Pascoe,Steven, Y1 - 2017/08/14/ PY - 2017/05/17/received PY - 2017/08/07/revised PY - 2017/08/11/accepted PY - 2017/9/27/entrez PY - 2017/9/28/pubmed PY - 2018/6/5/medline KW - Asthma KW - Chronic obstructive pulmonary disease KW - Inhaled corticosteroids KW - Long-acting muscarinic antagonist KW - Umeclidinium SP - 148 EP - 157 JF - Respiratory medicine JO - Respir Med VL - 131 N2 - INTRODUCTION: The long-acting muscarinic antagonist, umeclidinium (UMEC), combined with the inhaled corticosteroid, fluticasone furoate (FF), improves lung function in symptomatic patients with asthma. We assessed FF/UMEC in patients with a primary diagnosis of asthma or chronic obstructive pulmonary disease (COPD), but physiological characteristics of both (fixed airflow obstruction and reversibility to salbutamol). METHODS: This double-blind, parallel-arm, 3-phase study randomised 338 patients (1:1:1:1:2:2) to FF 100 mcg alone or combined with UMEC (15.6, 62.5, 125, or 250 mcg) or vilanterol 25 mcg (Phase A, 4 weeks). Primary endpoint: change from baseline in clinic trough forced expiratory volume in 1 s (FEV1) (end of Phase A). Secondary endpoints: morning peak expiratory flow (PEF), rescue medication use and Evaluating Respiratory Symptoms in COPD (E-RS™: COPD) scores. Safety was assessed. RESULTS: In the intent-to-treat population, the increase in trough FEV1 over FF was significant for FF/UMEC 62.5 (0.140 L [p = 0.019]) and 125 mcg (0.120 L [p = 0.039]), with similar changes for patients with a primary diagnosis of asthma or COPD. Changes from baseline in morning PEF and E-RS total score were greater for all FF/UMEC doses vs FF (p ≤ 0.05). Change from baseline in rescue medication use was statistically or clinically significant for all FF/UMEC doses vs FF. The incidence of on-treatment adverse events was 15%-32% (Phase A), with no dose-related effects. CONCLUSIONS: FF/UMEC 62.5 mcg produced clinically meaningful improvements in FEV1, morning PEF, E-RS total score and rescue medication use. FF/UMEC may benefit patients with features of both asthma and COPD. CLINICALTRIALS.GOV: NCT02164539; GSK: 200699. SN - 1532-3064 UR - https://www.unboundmedicine.com/medline/citation/28947022/The_effect_of_umeclidinium_on_lung_function_and_symptoms_in_patients_with_fixed_airflow_obstruction_and_reversibility_to_salbutamol:_A_randomised_3_phase_study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0954-6111(17)30276-7 DB - PRIME DP - Unbound Medicine ER -