- Post-albuterol FEV1 <70%% and >=30 % predicted (Hankinson)
- An increase in FEV1 after 4 puffs albuterol sulfate HFA of at least 5% and 50ml
Exclusion Criteria:
- Presence of other clinically significant illnesses or condition that might interfere
with the study, including but not limited to uncontrolled hypertension,
cardiovascular disease, cardiac arrhythmia, diabetes, hyperthyroidism, seizure
disorder or any history of pheochromocytoma
- History of asthma (in the opinion of the investigator)
- A COPD exacerbations within the past 2 months requiring oral corticosteroids or
hospitalization.
- Continuous oxygen therapy greater than 12 hours per day
- Subjects with a body mass index less than 15 or greater than 38
- Known allergy or contradiction to albuterol, arformoterol, salmeterol, tiotropium or
prior significant adverse reactions to other beta agonists or ipratropium.
- Hypersensitivity to milk protein. Bloating or gas from lactose is not an exclusion.
- Inability to withhold other adrenergic drugs (salmeterol, arformoterol, formoterol,
albuterol etc.) for an appropriate duration before each visit.
- Ongoing need for drugs which might potentiate hypokalemia (xanthine derivatives
(theophylline), steroids, non-potassium sparing diuretics (unless in fixed
combination with potassium sparing diuretic)
- Ongoing need for drugs which might cause QTc prolongation (MAO inhibitors, tricyclic
antidepressants, cardiac anti-arrhythmics Class Ia (e. g., disopyramide, procainamide,
quinidine), or class III (e. g., amiodarone, dofetilide, ibutilide, sotalol),
terfenadine, astemizole, mizolastin and any other drug with potential to
significantly prolong the QT interval.)
- Ongoing need for beta-blockers (selective or non-selective)
- Use of phenothizines (thioridizine), or other drugs that may interact with
arformoterol, salmeterol or albuterol for the duration of the study. Washout of
greater than seven half-lives of the drug prior to the study.
- History of angle closure glaucoma, symptomatic prostatic hypertrophy or bladder neck
obstruction.
- Investigational drugs within 30 days
- Affiliation with the Division of Pulmonary and Critical Care Medicine, David Geffen
School of Medicine
- Pregnancy, breastfeeding, planning to become pregnant during study, or woman of
childbearing potential unwilling to use adequate contraception