Exercise-induced BronchospasmPhase 3NCT00268723
Efficacy Study of Single-Dose Levalbuterol Tartrate HFA MDI Vs Placebo in Subjects 18 Years and Older With EIB
A Phase 3 study testing Levalbuterol tartrate HFA MDI in people with Exercise-induced Bronchospasm, run by Sumitomo Pharma America, Inc. at 2 sites in United States.
Trial summary
To determine if administration of levalbuterol tartrate HFA MDI in subjects with EIB will be effective in the prevention of EIB and be safe and well-tolerated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Exercise-induced Bronchospasm
- What is being tested?
- Levalbuterol tartrate HFA MDI
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2005to Feb 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects were males or females and 18 years of age or older at the time of consent.
- Female subjects considered not of childbearing potential were either surgically sterile or greater than one-year postmenopausal, defined as a complete cessation of menstruation for at least one year.
- Female subjects of child-bearing potential had a negative urine pregnancy test at screening.
- Female subjects of child-bearing potential agreed to use an acceptable method of birth control throughout the study.
- Subjects were in good health and were not suffering from any chronic condition that might affect their respiratory or cardiac function (including cardiac arrhythmias).
- Subjects had a documented diagnosis of exercise-induced bronchospasm for a minimum of 6 months prior to study start.
- Subjects had stable baseline asthma and had been using a beta2-adrenergic agonist, and/or anti-asthma anti-inflammatory medication, and/or over-the-counter asthma medication for at least 6 months prior to study start.
Who cannot join
- Subjects with currently diagnosed life-threatening asthma defined as a history of: asthma episodes requiring intubation, associated hypercapnia, respiratory arrest, or hypoxic seizures within 12 months prior to study start.
- Subjects with a history of hospitalization for asthma within 4 weeks prior to study start, or who were scheduled for in-patient hospitalization, including elective surgery, during the course of the trial.
- Subjects with a documented history of bronchopulmonary aspergillosis or any form of allergic alveolitis.
- Subjects who suffered from a clinically significant upper or lower respiratory tract infection in the 3 weeks prior to study start.
- Subjects with any clinically significant unstable medical abnormality, chronic disease (other than asthma), or history of a clinically significant abnormality of the cardiovascular, gastrointestinal, respiratory, hepatic, renal, endocrine, or central nervous systems that was not currently well controlled by medication or that may have interfered with the successful completion of the protocol.
- Subjects with a history of cancer (exception: basal-cell carcinoma in remission for a minimum of 5 years).
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- Subjects with a known sensitivity to levalbuterol, racemic albuterol, or any of the excipients contained in any of these formulations.
- Subjects using any prescription drug with which levalbuterol tartrate administration is contraindicated.
- Subjects with a history of substance abuse or drug abuse within 12 months preceding study start.
- Subjects who participated in an investigational drug study within 30 days prior to study start, or who were currently participating in another clinical trial.
- Subjects with a greater than 10-pack-year history of cigarette smoking or use of any tobacco products within 6 months of study start.
- Subject was a staff member or relative of a staff member.
- Subjects with unstable asthma, or had a change in asthma therapy, or a visit to the emergency department or hospital for worsening asthma within 4 weeks of study start.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Study site
Burke, Virginia
Study site
Denver, Colorado
About this study
Official title: An Efficacy Study of Single-Dose Levalbuterol Tartrate HFA MDI Versus Placebo in Prevention of EIB in Subjects 18 Years of Age and Older With EIB
To determine if administration of levalbuterol tartrate HFA MDI in subjects with EIB will be effective in the prevention of EIB and be safe and well-tolerated.
Read the detailed description
This was a randomized, double-blind, placebo-controlled, multicenter, two-way crossover study of levalbuterol tartrate HFA MDI in subjects 18 years of age and older with EIB. 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
- Exercise-induced Bronchospasm
- Being tested
- Levalbuterol tartrate HFA MDI, Placebo
- Medical subject headings
- Asthma, Exercise-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levalbuterol tartrate HFA MDIDrug
Also called Xopenex MDI
levalbuterol MDI 90 mcg QID
PlaceboDrug
Placebo MDI QID
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | levalbuterol HFA MDI 90 mcg QID Receives: Drug: Levalbuterol tartrate HFA MDI |
| 2 | Placebo comparator | Placebo MDI QID Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
maximum percent FEV1 decrease from visit postdose/prechallenge
Measured: Days 1, 4, 7
Secondary outcomes (6)
FEV1 area under the curve (AUC0-60 mins) (% decrease from visit postdose/prechallenge)
Measured: Days 1, 4, 7
time to FEV1 recovery
Measured: Days 1, 4, 7
minimum percent change in FEV1 from visit postdose/prechallenge
Measured: Days 1, 4, 7
minimum percent change in FEV1 from visit predose
Measured: Days 1, 4, 7
protected/unprotected subject counts (unprotected: >20% decrease; moderately protected: 10% to 20% decrease; and protected: <10% decrease from postdose/prechallenge FEV1)
Measured: Days 1, 4, 7
percent change in FEV1 from predose to postdose/prechallenge
Measured: Days 1, 4, 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2005 (estimated)
- Study startDec 2005
- Primary completionFeb 2006
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise-induced BronchospasmStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sumitomo Pharma America, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00268723
- Sponsor's protocol ID
- 051-925
- Status last verified
- Feb 2012
- First submitted
- 20 Dec 2005
- 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
- An Efficacy Study of Single-Dose Levalbuterol Tartrate HFA MDI Versus Placebo in Prevention of EIB in Subjects 18 Years of Age and Older With EIB
- ClinicalTrials.gov ID
- NCT00268723
- Acronym / sponsor ID
- 051-925
- Conditions
- Exercise-induced Bronchospasm
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 22 Dec 2005 (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.
To determine if administration of levalbuterol tartrate HFA MDI in subjects with EIB will be effective in the prevention of EIB and be safe and well-tolerated.
Detailed description
This was a randomized, double-blind, placebo-controlled, multicenter, two-way crossover study of levalbuterol tartrate HFA MDI in subjects 18 years of age and older with EIB. 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
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Levalbuterol tartrate HFA MDIlevalbuterol HFA MDI 90 mcg QID |
| 2 | Placebo comparator | Drug: PlaceboPlacebo MDI QID |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects were males or females and 18 years of age or older at the time of consent.
- Female subjects considered not of childbearing potential were either surgically sterile or greater than one-year postmenopausal, defined as a complete cessation of menstruation for at least one year.
- Female subjects of child-bearing potential had a negative urine pregnancy test at screening.
- Female subjects of child-bearing potential agreed to use an acceptable method of birth control throughout the study.
- Subjects were in good health and were not suffering from any chronic condition that might affect their respiratory or cardiac function (including cardiac arrhythmias).
Key exclusion criteria (13 listed)
- Subjects with currently diagnosed life-threatening asthma defined as a history of: asthma episodes requiring intubation, associated hypercapnia, respiratory arrest, or hypoxic seizures within 12 months prior to study start.
- Subjects with a history of hospitalization for asthma within 4 weeks prior to study start, or who were scheduled for in-patient hospitalization, including elective surgery, during the course of the trial.
- Subjects with a documented history of bronchopulmonary aspergillosis or any form of allergic alveolitis.
- Subjects who suffered from a clinically significant upper or lower respiratory tract infection in the 3 weeks prior to study start.
- Subjects with any clinically significant unstable medical abnormality, chronic disease (other than asthma), or history of a clinically significant abnormality of the cardiovascular, gastrointestinal, respiratory, hepatic, renal, endocrine, or central nervous systems that was not currently well controlled by medication or that may have interfered with the successful completion of the protocol.
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 tartrate HFA MDIAlso: Xopenex MDIlevalbuterol MDI 90 mcg QID | Drug | 1 |
| PlaceboPlacebo MDI QID | Drug | 2 |
Primary outcome
maximum percent FEV1 decrease from visit postdose/prechallenge
Time frame: Days 1, 4, 7
6 secondary outcomes
FEV1 area under the curve (AUC0-60 mins) (% decrease from visit postdose/prechallenge)
Time frame: Days 1, 4, 7
time to FEV1 recovery
Time frame: Days 1, 4, 7
minimum percent change in FEV1 from visit postdose/prechallenge
Time frame: Days 1, 4, 7
minimum percent change in FEV1 from visit predose
Time frame: Days 1, 4, 7
protected/unprotected subject counts (unprotected: >20% decrease; moderately protected: 10% to 20% decrease; and protected: <10% decrease from postdose/prechallenge FEV1)
Time frame: Days 1, 4, 7
percent change in FEV1 from predose to postdose/prechallenge
Time frame: Days 1, 4, 7
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.
The record lists no contact. Use the official record to reach the sponsor.
2 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 tartrate HFA MDI in people with Exercise-induced Bronchospasm, run by Sumitomo Pharma America, Inc. at 2 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 7 inclusion and 13 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 2 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. Some participants in this study may receive a placebo. 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?
maximum percent FEV1 decrease from visit postdose/prechallenge (time frame: Days 1, 4, 7). 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.