Chronic Obstructive Pulmonary DiseasePhase 4NCT00633776
Perforomist Versus Foradil Evaluated by Inspiratory Capacity and High Resolution Computed Tomography (HRCT)
A Phase 4 study testing formoterol fumarate in people with Chronic Obstructive Pulmonary Disease and COPD, run by University of California, Los Angeles at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, COPD, Chronic Bronchitis
- What is being tested?
- formoterol fumarate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Jan 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA David Geffen School of Medicine
Los Angeles, California, 90095
About this study
Official title: 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.
Read the 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.
- Being tested
- formoterol fumarate
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD, Chronic bronchitis, Emphysema, Perforomist, Foradil, CT, lung function
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Bronchitis, Chronic, Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
formoterol fumarateDrug
Also called Perforomist (nebulized formoterol fumarate), Foradil (aerosolizer dry powder formoterol fumarate)
Nebulized formoterol fumarate 20 mcg one-time treatment; aerosolizer dry powder formoterol fumarate 12 mcg one-time treatment
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: formoterol fumarate |
| 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 Receives: Drug: formoterol fumarate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Distal airway measurements in COPD using inspiratory capacity as measure of small airways patency
Measured: End of study
Secondary outcomes (1)
Differences in anatomic lobar air-trapping by HRCT due to small airways dilation between Perforomist and Foradil
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2008 (estimated)
- Study startMar 2008
- Primary completionJan 2009 (estimated)
- Study completionJan 2009 (estimated)
Why it stopped: Sponsor withdrew funding prior to study initiation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Dey, L.P.
- Investigators
- Donald P Tashkin, M.D., Principal investigator, University of California, Los AngelesEric Kleerup, M.D., Study director, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00633776
- Sponsor's protocol ID
- Perforomist CT Study
- Status last verified
- Aug 2016
- First submitted
- 4 Mar 2008
- Last updated
- 4 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perforomist Versus Foradil Evaluated by Inspiratory Capacity and HRCT
- ClinicalTrials.gov ID
- NCT00633776
- Acronym / sponsor ID
- Perforomist CT Study
- Keywords
- Chronic Obstructive Pulmonary Disease, COPD, Chronic bronchitis, Emphysema, Perforomist, Foradil, CT, lung function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor withdrew funding prior to study initiation
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Dey, L.P.
- Study start
- Mar 2008
- Primary completion
- Jan 2009 (estimated)
- Study completion
- Jan 2009 (estimated)
- First posted
- 12 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: formoterol fumarateFormoterol 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 |
| 2 | Active comparator | Drug: formoterol fumarateFormoterol 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 |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| formoterol fumarateAlso: Perforomist (nebulized formoterol fumarate), Foradil (aerosolizer dry powder formoterol fumarate)Nebulized formoterol fumarate 20 mcg one-time treatment; aerosolizer dry powder formoterol fumarate 12 mcg one-time treatment | Drug | 1, 2 |
Primary outcome
Distal airway measurements in COPD using inspiratory capacity as measure of small airways patency
Time frame: End of study
1 secondary outcome
Differences in anatomic lobar air-trapping by HRCT due to small airways dilation between Perforomist and Foradil
Time frame: End of study
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donald P Tashkin, M.D. principal investigator
University of California, Los Angeles
Eric Kleerup, M.D. study director
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing formoterol fumarate in people with Chronic Obstructive Pulmonary Disease and COPD, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distal airway measurements in COPD using inspiratory capacity as measure of small airways patency (time frame: End of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2016.