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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Perforomist Versus Foradil Evaluated by Inspiratory Capacity and HRCT

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00633776
• Other study ID #: Perforomist CT Study
• Status: Withdrawn
• Phase: Phase 4
• First received: March 4, 2008
• Last updated: August 2, 2016
• Start date: March 2008
• Est. completion date: January 2009

Study information

• Verified date: August 2016
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Bronchitis
• Bronchitis, Chronic
• Chronic Bronchitis
• Chronic Obstructive Pulmonary Disease
• COPD
• Emphysema
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive
• Pulmonary Emphysema

Intervention

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

Locations

Country	Name	City	State
United States	UCLA David Geffen School of Medicine	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	Dey, L.P.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distal airway measurements in COPD using inspiratory capacity as measure of small airways patency		End of study	No
Secondary	Differences in anatomic lobar air-trapping by HRCT due to small airways dilation between Perforomist and Foradil		End of study	No