Perforomist Versus Foradil Evaluated by Inspiratory Capacity and High Resolution Computed Tomography (HRCT)

Condition(s) targeted: Chronic Obstructive Pulmonary Disease; COPD; Chronic Bronchitis; Emphysema

Intervention: formoterol fumarate (Drug)

Phase: Phase 4

Status: Withdrawn

Sponsored by: University of California, Los Angeles

Official(s) and/or principal investigator(s):
Donald P Tashkin, M.D., Principal Investigator, Affiliation: UCLA David Geffen School of Medicine
Eric Kleerup, M.D., Study Director, Affiliation: UCLA David Geffen School of Medicine

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.

Official title: Perforomist Versus Foradil Evaluated by Inspiratory Capacity and HRCT

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Distal airway measurements in COPD using inspiratory capacity as measure of small airways patency

Secondary outcome: Differences in anatomic lobar air-trapping by HRCT due to small airways dilation between Perforomist and Foradil

Detailed description: 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 vice versa.

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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

hospitalization.

- 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

potential

- 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

exclusion.

- 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

sparing diuretic.

- 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

Exclusion Criteria:

- 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

UCLA David Geffen School of Medicine, Los Angeles, California 90095, United States

Starting date: March 2008
Last updated: September 24, 2008