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

This study has been withdrawn prior to enrollment.
(Sponsor withdrew funding prior to study initiation)
Sponsor:
Collaborator:
Dey, L.P.
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00633776
First received: March 4, 2008
Last updated: September 24, 2008
Last verified: September 2008
  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 4

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Donald Tashkin, M.D., University of California, Los Angeles (UCLA) David Geffen School of Medicine
ClinicalTrials.gov Identifier: NCT00633776     History of Changes
Other Study ID Numbers: Perforomist CT Study
Study First Received: March 4, 2008
Last Updated: September 24, 2008
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

Additional relevant MeSH terms:
Respiratory Aspiration
Bronchitis
Bronchitis, Chronic
Emphysema
Pulmonary Emphysema
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Bronchial Diseases
Respiratory Tract Infections
Pathologic Processes
Formoterol
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 29, 2014