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

NCT ID: NCT00633776

Last Updated: 2016-08-04

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE4
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2009-01-31

Brief Summary

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.

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.

Conditions

Chronic Obstructive Pulmonary Disease; COPD; Chronic Bronchitis; Emphysema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

Formoterol fumarate 20 mcg (Perforomist) nebulized via Pari C nebulizer at Test Visit 1; Formoterol 12 mcg (Foradil) via aerosolizer dry powder inhaler at Test Visit 2

Group Type: EXPERIMENTAL

formoterol fumarate

Intervention Type: DRUG

Nebulized formoterol fumarate 20 mcg one-time treatment; aerosolizer dry powder formoterol fumarate 12 mcg one-time treatment

2

Formoterol fumarate 12 mcg (Foradil) via aerosolizer dry powder inhaler at Test Visit 1; Formoterol fumarate 20 mcg (Perforomist) nebulized via Pari C nebulizer at Test Visit 2

Group Type: ACTIVE_COMPARATOR

formoterol fumarate

Intervention Type: DRUG

Nebulized formoterol fumarate 20 mcg one-time treatment; aerosolizer dry powder formoterol fumarate 12 mcg one-time treatment

Interventions

formoterol fumarate

Nebulized formoterol fumarate 20 mcg one-time treatment; aerosolizer dry powder formoterol fumarate 12 mcg one-time treatment

Intervention Type: DRUG

Other Intervention Names

Perforomist (nebulized formoterol fumarate); Foradil (aerosolizer dry powder formoterol fumarate)

Eligibility 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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dey, L.P.

UNKNOWN

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

University of California, Los Angeles (UCLA) David Geffen School of Medicine

Principal Investigators

Donald P Tashkin, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Eric Kleerup, M.D.

Role: STUDY_DIRECTOR

University of California, Los Angeles

Locations

UCLA David Geffen School of Medicine

Los Angeles, California, United States

Countries

United States

Other Identifiers

Perforomist CT Study

Identifier Type: -

Identifier Source: org_study_id