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

August 2, 2016 updated by: University of California, Los Angeles

Perforomist Versus Foradil Evaluated by Inspiratory Capacity and HRCT

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / 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.

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90095
        • UCLA david geffen school of medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Distal airway measurements in COPD using inspiratory capacity as measure of small airways patency
Time Frame: End of study
End of study

Secondary Outcome Measures

Outcome Measure
Time Frame
Differences in anatomic lobar air-trapping by HRCT due to small airways dilation between Perforomist and Foradil
Time Frame: End of study
End of study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Los Angeles

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Anticipated)

January 1, 2009

Study Completion (Anticipated)

January 1, 2009

Study Registration Dates

First Submitted

March 4, 2008

First Submitted That Met QC Criteria

March 11, 2008

First Posted (Estimate)

March 12, 2008

Study Record Updates

Last Update Posted (Estimate)

August 4, 2016

Last Update Submitted That Met QC Criteria

August 2, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Perforomist CT Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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