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

NCT00633776 | Withdrawn Phase 4

• 1 other identifier: Perforomist CT Study
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease; COPD; Chronic Bronchitis; Emphysema

Keywords

Chronic Obstructive Pulmonary Disease; COPD; Chronic bronchitis; Emphysema; Perforomist; Foradil; CT; lung function

Outcome Measures

Primary Outcomes (1)

• Distal airway measurements in COPD using inspiratory capacity as measure of small airways patency

  End of study

Secondary Outcomes (1)

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

  End of study

Study Arms (2)

1

EXPERIMENTAL

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

Drug: formoterol fumarate

2

ACTIVE COMPARATOR

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

Drug: formoterol fumarate

Interventions

formoterol fumarate DRUG

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

Also known as: Perforomist (nebulized formoterol fumarate), Foradil (aerosolizer dry powder formoterol fumarate)

1; 2

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Dey, L.P.: collaborator

Study Sites (1)

UCLA David Geffen School of Medicine

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Bronchitis, Chronic; Emphysema

Interventions

Formoterol Fumarate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Officials

• Donald P Tashkin, M.D.

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

• Eric Kleerup, M.D.

  University of California, Los Angeles

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 4, 2008
• First Posted: March 12, 2008
• Study Start: March 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: August 4, 2016

Record last verified: 2016-08

Locations

US (1)