cross-over study in subjects with copd, evaluating lung function response after treatment with once daily umeclidinium 62.5mcg, vilanterol 25mcg, and umeclidinium/vilanterol 62.5/25mcg

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: the purpose of this study is to evaluate the lung function response to umec/vi, umec, and vi in individual patients using a cross-over design. this is a multicenter, randomized, double-blind, 3-way crossover study. eligible subjects will be randomized to a sequence of umec 62.5mcg, vi 25mcg, and umec/vi 62.5/25mcg. all subjects will receive each treatment once-daily for 14 days, and each treatment will be separated by a 10-14 day washout period. there will be a 5-7 day run-in period prior to randomization.


Eligibility criteria:
inclusion criteria: * type of patient: outpatient * informed consent: a signed and dated written informed consent prior to study participation * age: subjects 40 years of age or older at visit 1 * gender: male or female subjects. * copd diagnosis: as defined by the american thoracic society/european respiratory society (ats/ers) * severity of disease: a pre- and post-salbutamol fev1/fvc ratio of \<0.70 and a pre- and post-salbutamol fev1 of ≤ 70% of predicted normal values at visit 1 * smoking history: current or former cigarette smokers with a history of cigarette smoking of ≥ 10 pack-years at visit 1 * female subject of non child-bearing potential or a female subject of child bearing potential, with a negative pregnancy test at screening, and agreeing to consistently and correctly use one of the acceptable contraceptive methods exclusion criteria: * pregnancy: women who are pregnant or lactating or are planning on becoming pregnant during the study * asthma: a current diagnosis of asthma * other respiratory disorders: known alpha-1 antitrypsin deficiency, active lung infections (such as tuberculosis), and lung cancer are absolute exclusionary conditions. * other diseases/abnormalities: subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled and/or a previous history of cancer in remission for \< 5 years prior to visit 1 * contraindications: a history of allergy or hypersensitivity to any anticholinergic/muscarinic receptor antagonist, beta2-agonist, lactose/milk protein or magnesium stearate or a medical condition such as of narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the study physician contraindicates study participation or use of an inhaled anticholinergic. * hospitalization: hospitalization for copd or pneumonia within 12 weeks prior to visit 1. * lung resection: subjects with lung volume reduction surgery within the 12 months prior to visit 1. * 12-lead ecg: an abnormal and significant ecg finding from the 12-lead ecg conducted at visit 1 * screening labs: significantly abnormal finding from clinical chemistry or hematology tests at visit 1 as determined by the study investigator. * medication prior to spirometry: unable to withhold salbutamol for the 4 hour period required prior to spirometry testing at each study visit and at each spirometry test performed at home. * medications prior to screening: use of the prohibited medications according to defined time intervals prior to visit 1 * oxygen: use of long-term oxygen therapy (ltot) described as oxygen therapy prescribed for greater than 12 hours a day. as-needed oxygen use (i.e., ≤ 12 hours per day) is not exclusionary. * nebulized therapy: regular use (prescribed for use every day, not for as-needed use) of short-acting bronchodilators (e.g., salbutamol, ipratropium bromide) via nebulized therapy * pulmonary rehabilitation program: participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to visit 1. subjects who are in the maintenance phase of a pulmonary rehabilitation program are not excluded. * drug or alcohol abuse: a known or suspected history of alcohol or drug abuse within 2 years prior to visit 1. * affiliation with investigator site: is an investigator, sub-investigator, study coordinator, employee of a participating investigator or study site, or immediate family member of the aforementioned that is involved in this study. * inability to read: in the opinion of the investigator, any subject who is unable to read and/or would not be able to complete a questionnaire

Keywords: long-acting muscarinic antagonist long-acting beta-agonist chronic obstructive pulmonary disease vilanterol umeclidinium