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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00633776
Recruitment Status : Withdrawn (Sponsor withdrew funding prior to study initiation)
First Posted : March 12, 2008
Last Update Posted : August 4, 2016
Sponsor:
Collaborator:
Dey, L.P.
Information provided by:
University of California, Los Angeles

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease COPD Chronic Bronchitis Emphysema Drug: formoterol fumarate Phase 4

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Perforomist Versus Foradil Evaluated by Inspiratory Capacity and HRCT
Study Start Date : March 2008
Estimated Primary Completion Date : January 2009
Estimated Study Completion Date : January 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 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
 Drug: formoterol fumarate
Nebulized formoterol fumarate 20 mcg one-time treatment; aerosolizer dry powder formoterol fumarate 12 mcg one-time treatment
Other Names:
  • Perforomist (nebulized formoterol fumarate)
  • Foradil (aerosolizer dry powder formoterol fumarate)
Active Comparator: 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
 Drug: formoterol fumarate
Nebulized formoterol fumarate 20 mcg one-time treatment; aerosolizer dry powder formoterol fumarate 12 mcg one-time treatment
Other Names:
  • Perforomist (nebulized formoterol fumarate)
  • Foradil (aerosolizer dry powder formoterol fumarate)


Outcome Measures
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Primary Outcome Measures :
  1. Distal airway measurements in COPD using inspiratory capacity as measure of small airways patency [ Time Frame: End of study ]

Secondary Outcome Measures :
  1. Differences in anatomic lobar air-trapping by HRCT due to small airways dilation between Perforomist and Foradil [ Time Frame: End of study ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00633776


Locations
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United States, California
UCLA David Geffen School of Medicine
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Dey, L.P.
Investigators
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Principal Investigator: Donald P Tashkin, M.D. UCLA David Geffen School of Medicine
Study Director: Eric Kleerup, M.D. UCLA David Geffen School of Medicine
More Information
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Responsible Party: Donald Tashkin, M.D., University of California, Los Angeles (UCLA) David Geffen School of Medicine
ClinicalTrials.gov Identifier: NCT00633776    
Other Study ID Numbers: Perforomist CT Study
First Posted: March 12, 2008    Key Record Dates
Last Update Posted: August 4, 2016
Last Verified: August 2016
Keywords provided by University of California, Los Angeles:
Chronic Obstructive Pulmonary Disease
COPD
Chronic bronchitis
Emphysema
 Perforomist
Foradil
CT
lung function
Additional relevant MeSH terms:
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Bronchitis
Bronchitis, Chronic
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Pulmonary Emphysema
Emphysema
Respiratory Tract Diseases
Pathologic Processes
Respiratory Tract Infections
Infections
Bronchial Diseases
Formoterol Fumarate
 Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action