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Perforomist Versus Foradil Evaluated by Inspiratory Capacity and High Resolution Computed Tomography (HRCT)
This study has been withdrawn prior to recruitment.
( Sponsor withdrew funding prior to study initiation )
First Received: March 4, 2008   Last Updated: September 24, 2008   History of Changes
Sponsors and Collaborators: University of California, Los Angeles
Dey, L.P.
Information provided by: University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT00633776
  Purpose

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 Intervention Phase
Chronic Obstructive Pulmonary Disease
COPD
Chronic Bronchitis
Emphysema
Drug: formoterol fumarate
Phase IV

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Crossover Assignment, Efficacy Study
Official Title: Perforomist Versus Foradil Evaluated by Inspiratory Capacity and HRCT

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Distal airway measurements in COPD using inspiratory capacity as measure of small airways patency [ Time Frame: End of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Differences in anatomic lobar air-trapping by HRCT due to small airways dilation between Perforomist and Foradil [ Time Frame: End of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: March 2008
Estimated Study Completion Date: January 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Nebulized formoterol fumarate 20 mcg one-time treatment; aerosolizer dry powder formoterol fumarate 12 mcg one-time treatment
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
Nebulized formoterol fumarate 20 mcg one-time treatment; aerosolizer dry powder formoterol fumarate 12 mcg one-time treatment

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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00633776

Locations
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
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

No publications provided

Responsible Party: University of California, Los Angeles (UCLA) David Geffen School of Medicine ( Donald Tashkin, M.D. )
Study ID Numbers: Perforomist CT Study
Study First Received: March 4, 2008
Last Updated: September 24, 2008
ClinicalTrials.gov Identifier: NCT00633776     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
Chronic Obstructive Pulmonary Disease
COPD
Chronic bronchitis
Emphysema
Perforomist
Foradil
CT
lung function

Study placed in the following topic categories:
Emphysema
Neurotransmitter Agents
Adrenergic beta-Agonists
Bronchial Diseases
Adrenergic Agents
Respiration Disorders
Anti-Asthmatic Agents
Adrenergic Agonists
Pulmonary Emphysema
Bronchitis, Chronic
Lung Diseases, Obstructive
Respiratory Tract Diseases
Respiratory Tract Infections
Lung Diseases
Formoterol
Bronchitis
Peripheral Nervous System Agents
Bronchodilator Agents
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:
Respiratory System Agents
Neurotransmitter Agents
Bronchial Diseases
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic Agonists
Pulmonary Emphysema
Lung Diseases, Obstructive
Pathologic Processes
Respiratory Tract Infections
Respiratory Tract Diseases
Therapeutic Uses
Formoterol
Bronchitis
Emphysema
Adrenergic beta-Agonists
Respiration Disorders
Anti-Asthmatic Agents
Pharmacologic Actions
Bronchitis, Chronic
Autonomic Agents
Lung Diseases
Peripheral Nervous System Agents
Bronchodilator Agents
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on September 10, 2009