AsthmaPhase 3NCT00583986
Reliability of a Top Mount Actuation Indicator With Levalbuterol MDI in Adult and Pediatric Subjects With Asthma or COPD
A Phase 3 study testing Levalbuterol HFA MDI with top mounted actuation indicator in people with Asthma and Chronic Obstructive Pulmonary Disease, run by Sumitomo Pharma America, Inc. at 26 sites in United States.
Trial summary
This is a study to investigate the reliability, ruggedness and safety of the top mounted actuation indicator (TMAI) when used with Levalbuterol HFA MDI. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Asthma, Chronic Obstructive Pulmonary Disease, COPD
- What is being tested?
- Levalbuterol HFA MDI with top mounted actuation indicator
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 26 sitesUnited States
- Study dates
- Sep 2005to Mar 2006
- Phase
- Phase 3
- 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 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject must have a documented diagnosis of asthma or COPD for a minimum of 6 months.
- Subject must have stable baseline asthma or COPD and have been using a beta-adrenergic agonist, and/or anti-asthma anti-inflammatory medication, and/or over-the-counter asthma medication for at least 6 months.
- Subject must be in good health with the exception of their reversible airways disease and not suffering from any chronic condition that might affect their respiratory function.
Who cannot join
- Female subject who is pregnant or lactating.
- Subject who has a history of hospitalization for asthma or COPD within 45 days.
- Subject with currently diagnosed life-threatening asthma or COPD, defined as a history of asthma or COPD episodes requiring intubation, associated with hypercapnia, respiratory arrest, or hypoxic seizures within 3 months prior.
- Subject with supplemental oxygen use
- Subject with a history of cancer
- Subject with hyperthyroidism, diabetes, hypertension, cardiac diseases, or seizure disorders that currently are not well controlled by medication.
- Subject with asthma with a greater than 10-pack per year history of cigarette smoking or use of any tobacco products within 6 months.
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
United States26 sites
Study site
Austin, Texas, 78750
Study site
Braunfels, Texas, 78130
Study site
Burke, Virginia, 22015
Study site
Chattanooga, Tennessee, 37421
Study site
Commack, New York, 11725
Study site
Elizabeth City, North Carolina, 27909
Study site
Encinatas, California, 92024
Study site
Huntington Beach, California, 92647
Study site
Medford, Oregon, 97504
Study site
Mesa, California, 92626
Study site
Morgantown, West Virginia, 26505
Study site
Oklahoma City, Oklahoma, 73120
Study site
Orange County, California, 92868
Study site
Philadelphia, Pennsylvania, 19115
Study site
Portland, Oregon, 97213
Study site
Richmond, Virginia, 23225
Study site
Riverside, California, 92506
Study site
Rochester, New York, 14618
Study site
Russells Mills, Massachusetts, 02747
Study site
San Antonio, Texas, 78229
Study site
San Diego, California, 92120
Study site
San Jose, California, 95128
Study site
Simpsonville, South Carolina, 29681
Study site
Tamarac, Florida, 33321
Study site
Viejo, California, 92691
Study site
Walnut Creek, California, 94596
About this study
Official title: A Study to Determine the Reliability of a Top Mount Actuation Indicator When Used With Levalbuterol Tartrate HFA MDI in Adult and Pediatric Subjects With Asthma or Chronic Obstructive Pulmonary Disease
This is a study to investigate the reliability, ruggedness and safety of the top mounted actuation indicator (TMAI) when used with Levalbuterol HFA MDI.
Read the detailed description
This is an open-label, multicenter, TMAI study with Levalbuterol HFA MDI in adult and pediatric subjects with asthma or COPD. Period I: One week, open-label, run-in period during which subjects must have asthma or COPD symptoms requiring use of, as needed, Levalbuterol HFA MDI(without TMAI) on at least half of the days [4-12 actuations on a single day]. Period II: Nine week, open-label period during which subjects will use the Levalbuterol HFA MDI with TMAI PRN. The total study duration for a subject will not exceed 10 weeks. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.
- Conditions
- Asthma, Chronic Obstructive Pulmonary Disease, COPD
- Being tested
- Levalbuterol HFA MDI with top mounted actuation indicator
- Keywords
- top mounted, actuation indicator, Asthma, COPD, Chronic Obstructive Pulmonary Disease
- Medical subject headings
- Asthma, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levalbuterol HFA MDI with top mounted actuation indicatorDrug
Also called Xopenex HFA®
Levalbuterol HFA MDA with top mounted actuation indicator
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Levalbuterol HFA MDI with top mounted actuation indicator Receives: Drug: Levalbuterol HFA MDI with top mounted actuation indicator |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference between the number of actuations estimated via canister weight and the number of actuations recorded byt eh TMAI.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2008 (estimated)
- Study startSep 2005
- Primary completionJan 2006
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Hanrahan, M.D., Study chair, Sumitomo Pharma America, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00583986
- Sponsor's protocol ID
- 051-357
- Status last verified
- Feb 2012
- First submitted
- 21 Dec 2007
- Last updated
- 22 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Determine the Reliability of a Top Mount Actuation Indicator When Used With Levalbuterol Tartrate HFA MDI in Adult and Pediatric Subjects With Asthma or Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT00583986
- Acronym / sponsor ID
- 051-357
- Conditions
- Asthma, Chronic Obstructive Pulmonary Disease, COPD
- Keywords
- top mounted, actuation indicator, Asthma, COPD, Chronic Obstructive Pulmonary Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2005
- Primary completion
- Jan 2006 (actual)
- Study completion
- Mar 2006 (actual)
- First posted
- 2 Jan 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.
This is a study to investigate the reliability, ruggedness and safety of the top mounted actuation indicator (TMAI) when used with Levalbuterol HFA MDI.
Detailed description
This is an open-label, multicenter, TMAI study with Levalbuterol HFA MDI in adult and pediatric subjects with asthma or COPD. Period I: One week, open-label, run-in period during which subjects must have asthma or COPD symptoms requiring use of, as needed, Levalbuterol HFA MDI(without TMAI) on at least half of the days [4-12 actuations on a single day]. Period II: Nine week, open-label period during which subjects will use the Levalbuterol HFA MDI with TMAI PRN. The total study duration for a subject will not exceed 10 weeks. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Levalbuterol HFA MDI with top mounted actuation indicatorLevalbuterol HFA MDI with top mounted actuation indicator |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Subject must have a documented diagnosis of asthma or COPD for a minimum of 6 months.
- Subject must have stable baseline asthma or COPD and have been using a beta-adrenergic agonist, and/or anti-asthma anti-inflammatory medication, and/or over-the-counter asthma medication for at least 6 months.
- Subject must be in good health with the exception of their reversible airways disease and not suffering from any chronic condition that might affect their respiratory function.
Key exclusion criteria (7 listed)
- Female subject who is pregnant or lactating.
- Subject who has a history of hospitalization for asthma or COPD within 45 days.
- Subject with currently diagnosed life-threatening asthma or COPD, defined as a history of asthma or COPD episodes requiring intubation, associated with hypercapnia, respiratory arrest, or hypoxic seizures within 3 months prior.
- Subject with supplemental oxygen use
- Subject with a history of cancer
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 |
|---|---|---|
| Levalbuterol HFA MDI with top mounted actuation indicatorAlso: Xopenex HFA®Levalbuterol HFA MDA with top mounted actuation indicator | Drug | 1 |
Primary outcome
The difference between the number of actuations estimated via canister weight and the number of actuations recorded byt eh TMAI.
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2012.
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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.
John Hanrahan, M.D. study chair
Sumitomo Pharma America, Inc.
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levalbuterol HFA MDI with top mounted actuation indicator in people with Asthma and Chronic Obstructive Pulmonary Disease, run by Sumitomo Pharma America, Inc. at 26 sites 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 3 inclusion and 7 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: finished, as of the sponsor's last update on 22 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The difference between the number of actuations estimated via canister weight and the number of actuations recorded byt eh TMAI. (time frame: 10 weeks). 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 22 Feb 2012.