The purpose of this study is to compare the effects of nebulized formoterol fumarate
(Perforomist) to dry-powder inhaler formoterol fumarate (Foradil). Perforomist is a solution
that is made into very fine spray (using a nebulizer) that is then breathed in over 10-15
minutes. Foradil is taken in a single quick, deep inhalation.
Participation requires 3 visits over 1-5 weeks. The first visit (Screening) will help
determine subjects' eligibility through medical history, physical exam, lung function
testing, and exercise testing. Those who qualify will be invited back to 2 test visits, at
which subjects will undergo lung function testing and high-resolution CT scans before and
after treatment with one of the study drugs. All subjects will take both study drugs: those
who are randomized to Perforomist at Test Visit 1 will take Foradil at Test Visit 2, and
- Symptomatic subjects with moderate to severe COPD
- Age greater than/equal to 40 years
- History of smoking greater than/equal to 20 pack-years of cigarettes
- No history of asthma (in the opinion of the investigator)
- No COPD exacerbations within the past 2 months requiring oral corticosteroids or
- No continuous oxygen therapy
- Subjects with a body mass index less than 15 or greater than 38
- Patients must be without 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
- Be using medically acceptable birth-control measures if a female of child-bearing
- Not be pregnant or breastfeeding
- Be willing to withhold any existing short or long-acting bronchodilators for the
appropriate time period prior to each test day (see below). Use of inhaled
corticosteroids is not exclusionary, but will be maintained at a constant level
throughout the study.
- Must be willing and able to perform spirometry, slow vital capacity, plethysmography,
DLCO, and 6 minute walk after appropriate instruction.
- No known allergy or contradiction to albuterol or formoterol or prior significant
adverse reactions to other beta agonists.
- No hypersensitivity to milk protein. Bloating or gas from lactose is not an
- No use of beta-blockers (selective or non-selective), phenothiazines (thioridazine),
or other drugs that may interact with formoterol or albuterol for the duration of the
study. Washout of greater than seven half-lives of the drug prior to the study.
- No use of cardiac anti-arrhythmics Class Ia (e.g., disopyramide, procainamide,
quinidine), or class III (e.g., amiodarone, dofetilide, ibutilide, sotalol),
terfenadine, astemizole, mizolastine and any other drug with potential to
significantly prolong the QT interval.
- No use of non-potassium sparing diuretics unless in fixed combination with potassium
- No investigational drugs within 30 days
- No subjects affiliated with the Division of Pulmonary, Critical Care Medicine and
Hospitalists, David Geffen School of Medicine
- Informed consent
- Post-albuterol FEV1/FVC less than lower limit of normal (Hankinson)
- Post-albuterol FEV1 between 30% and 60% predicted (Hankinson)
- An increase in FEV1 after albuterol sulfate HFA of at least 5% and 50 ml