AsthmaPhase 3NCT00073827
Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older With Asthma
A Phase 3 study testing levalbuterol tartrate MDI and racemic albuterol MDI in people with Asthma, run by Sumitomo Pharma America, Inc. at 63 sites in United States.
Trial summary
The primary purpose of this study was to investigate the efficacy of levalbuterol compared to a placebo and compared to albuterol in the treatment and prevention of bronchoconstriction in adolescent and adult subjects with asthma, with all treatments administered 4 times a day (QID). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- levalbuterol tartrate MDI and racemic albuterol MDI
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 445 participants
- Where
- 63 sitesUnited States
- Study dates
- May 2002to Jan 2003
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Willing and able to comply with the study procedures and visit schedules
- Male or female, at least 12 years of age
- Female subjects 12-60 years of age must have a negative serum pregnancy test at study start.
- Women of child bearing potential must be using an acceptable method of birth control
- Have a documented diagnosis of asthma for a minimum of 6 months prior to study start
- Must have stable baseline asthma and have been using a B-adrenergic agonist, and/or anti-asthma anti-inflammatory medication, and/or OTC asthma medication for at least 6 months prior to study start
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- 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
- Must have a chest X-ray that is not diagnostic of pneumonia, atelectasis, pulmonary fibrotic disease, pneumothorax, chronic obstructive pulmonary disease, etc.
- Must be able to complete the diary cards and medical event calendars reliably on a daily basis, understand dosing instructions, and demonstrate how to use the MiniWright PEF meter.
Who cannot join
- Female subject who is pregnant or lactating
- Have participated in an investigational drug study within 30 days prior to study start, or who is currently participating in another clinical trial
- Subject whose schedule prevents him or her from taking the first daily dose of study medication and/or starting study visits before 9 AM
- Subject who has travel commitments during the study that would interfere with trial measurements or compliance
- Have a history of hospitalization for asthma within 45 days prior to study start, or who is scheduled for in-patient hospitalization, including elective surgery
- Have a known sensitivity to levalbuterol or racemic albuterol, or any excipients in any of these formulations
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- Subject using any prescription drug with which albuterol sulfate administration is contraindicated
- Subject with currently diagnosed life-threatening asthma
- History of cancer (exception: basal cell carcinoma in remission).
- Subject with hyperthyroidism, diabetes, hypertension, cardiac diseases or seizure disorders that currently are not well controlled by medication
- History of substance abuse or drug abuse within 12 months preceding study start
- Subject with greater than 10 pack year history of cigarette smoking or use of any tobacco products within 6 months of study start
- Documented history of bronchopulmonary aspergillosis or any form of allergic alveolitis
- Have suffered from a clinically significant upper or lower respiratory tract infection in the 2 weeks prior to study start
- Subject who is a staff member or relative of a staff member
Trial locations and contacts
63 sites in 1 country.
63 sites in 1 country
United States63 sites
PCCS
Albany, New York, 12205
Office of Constantine Saadeh
Amarillo, Texas, 79106
Regional Allergy & Asthma Consultants
Asheville, North Carolina, 28801
University of Maryland School of Medicine
Baltimore, Maryland
Radiant Research
Charleston, South Carolina, 29407
Asthma & Allergy Research Associates
Chester, Pennsylvania, 19013
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio, 45231
Office of Clinical Research, University of Missouri-Columbia
Columbia, Missouri, 65212
Integrated Research Group
Corona, California, 92879
Allergy & Asthma Research Associates
Dallas, Texas, 75231
Allergy & Asthma Medical Group of Diablo Valley, Inc.
Danville, California, 94526
National Jewish Medical & Research Center
Denver, Colorado, 80206
Henry Ford Health System
Detroit, Michigan, 48202
Radiant Research, Inc.
Encinitas, California, 92024
Clinical Research Centers of Colorado PC
Englewood, Colorado, 80112
Allergy & Asthma Research
Eugene, Oregon, 97401
North Texas Institute for Clinical Trials
Fort Worth, Texas, 76132
Office of Neil Kao
Greenville, South Carolina, 29607
Cornerstone Research Care
High Point, North Carolina, 27262
Alabama Asthma and Allergy Center
Homewood, Alabama, 35209
Radiant Research Honolulu
Honolulu, Hawaii, 96814
Breath of Life Research Institute
Houston, Texas, 77054
Allergy & Asthma Specialists Medical Group
Huntington Beach, California, 92647
Clinical Research Center of Indiana
Indianapolis, Indiana, 46208
Mississippi Asthma & Allergy Clinic
Jackson, Mississippi
The Children's Mercy Hospital
Kansas City, Missouri, 64108
Allergy, Asthma & Respiratory Care Center
Long Beach, California, 90806
Allergy Research Foundation, Inc.
Los Angeles, California, 90025
Allergy & Asthma Care Specialists
Metairie, Louisiana, 70006
Clinical Research Institute
Minneapolis, Minnesota, 55402
MDC Research
Mobile, Alabama, 36607
Allergy & Asthma Consultants, LLP
Mt. Pleasant, South Carolina, 29464
PCHI
Needham, Massachusetts, 02494
Children's Hospital of the Kings Daughters
Norfolk, Virginia, 23507
Northeast Medical Research Associates, Inc.
North Dartmouth, Massachusetts, 02747
Clinical Trials of Orange County
Orange, California, 92868
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Children's Hospital of Pittsburgh Division of Allergy, Immunology & Infectious Diseases
Pittsburgh, Pennsylvania, 15213
University of Pittsburgh Division of Pulmonary
Pittsburgh, Pennsylvania, 15213
Allergy Associates Research Center, LLC
Portland, Oregon, 97213
Princeton Center for Clinical Research
Princeton, New Jersey, 08540
Asthma & Allergy Associates, PC
Pueblo, Colorado, 81001
Raleigh Pediatric Associates
Raleigh, North Carolina, 27609
Pulmonary Associates of Richmond, Inc.
Richmond, Virginia, 23225
AAIR Research Center
Rochester, New York, 14618
Lung Diagnostics
San Antonio, Texas
Allergy Associates Medical Group
San Diego, California, 92120
Allergy & Asthma Medical Group & Research Center
San Diego, California, 92123
Allergy & Asthma Prevention & Treatment Center
San Diego, California, 92131
Allergy & Asthma Assoc. of Santa Clara Valley Research Center
San Jose, California, 95117
Aeroallergy Research Laboratories of Savannah, Inc.
Savannah, Georgia, 31406
ASTHMA, Inc.
Seattle, Washington, 98105
Northshore Medical Research
Slidell, Louisiana, 70458
Pulmonary and Allergy Associates
Springfield, New Jersey, 07081
Division of Allergy & Immunology, Washington Univ School of Med
St Louis, Missouri, 63110
St. Louis University
St Louis, Missouri, 63110
The Clinical Research Center, LLC
St Louis, Missouri, 63141
Bensch Research Associates
Stockton, California, 95207
Office of Ronald Saff
Tallahassee, Florida, 32308
Center for Clinical Research
Taunton, Massachusetts, 02780
Southern California Research Center
Viejo, California, 92691
Allergy & Asthma Center
Waco, Texas
Allergic Diseases, SC
West Allis, Wisconsin, 53227
About this study
Official title: An Efficacy and Safety Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older With Asthma
The primary purpose of this study was to investigate the efficacy of levalbuterol compared to a placebo and compared to albuterol in the treatment and prevention of bronchoconstriction in adolescent and adult subjects with asthma, with all treatments administered 4 times a day (QID).
Read the detailed description
This was a Phase III, multicenter, randomized, double-blind, placebo- and active-controlled, parallel-group study of up to 9 weeks in duration. Seven days of QID single-blind placebo administration (via MDI) was followed by 56 days of QID double-blind active treatment. Following the run-in period, each subject was randomized to one of the following three treatments: levalbuterol HFA MDI 90 mcg (2 actuations of 45 mcg), racemic albuterol HFA MDI 180 mcg (2 actuations of 90 mcg), or placebo (2 actuations). Subjects were randomized in a 2:1:1 ratio of levalbuterol to racemic albuterol to placebo. In order to maintain blinding of the device, a placebo dose was administered with each treatment. 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
- Being tested
- levalbuterol tartrate MDI, racemic albuterol MDI, Placebo
- Keywords
- adolescent, adult, asthma, levalbuterol, bronchoconstriction
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
levalbuterol tartrate MDIDrug
Also called Xopenex MDI
levalbuterol 90 mcg QID
racemic albuterol MDIDrug
racemic albuterol 180 mcg QID
PlaceboDrug
Placebo MDI QID
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | levalbuterol MDI 90 mcg QID Receives: Drug: levalbuterol tartrate MDI |
| 2 | Active comparator | racemic albuterol MDI 180 mcg QID Receives: Drug: racemic albuterol MDI |
| 3 | 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.
percent change in FEV1 from visit predose averaged over the 8-week double-blind period
Measured: Weeks 0, 4, 8
Secondary outcomes (7)
area under the FEV1 percent change curve from visit pre-dose and from study baseline curves averaged over the double-blind period
Measured: Weeks 0, 4, 8
peak percent change in FEV1 from study baseline
Measured: Weeks 0, 4, 8
peak change in FEV1 from visit predose
Measured: Weeks 0, 4, 8
peak percent of predicted FEV1
Measured: Weeks 0, 4, 8
area under the FEV1 curve (AUC)
Measured: Weeks 0, 4, 8
peak change and peak percent change in FEF25-75% from visit predose
Measured: Weeks 0, 4, 8
peak change and peak percent change in FVC from visit predose
Measured: Weeks 0, 4, 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2003 (estimated)
- Study startMay 2002
- Primary completionJan 2003
- Study completionJan 2003
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 445 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
- NCT00073827
- Sponsor's protocol ID
- 051-353
- Status last verified
- Feb 2012
- First submitted
- 9 Dec 2003
- 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 and Safety Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older With Asthma
- ClinicalTrials.gov ID
- NCT00073827
- Acronym / sponsor ID
- 051-353
- Conditions
- Asthma
- Keywords
- adolescent, adult, asthma, levalbuterol, bronchoconstriction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 445 participants (actual)
- Lead sponsor
- Sumitomo Pharma America, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2002
- Primary completion
- Jan 2003 (actual)
- Study completion
- Jan 2003 (actual)
- First posted
- 11 Dec 2003 (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 primary purpose of this study was to investigate the efficacy of levalbuterol compared to a placebo and compared to albuterol in the treatment and prevention of bronchoconstriction in adolescent and adult subjects with asthma, with all treatments administered 4 times a day (QID).
Detailed description
This was a Phase III, multicenter, randomized, double-blind, placebo- and active-controlled, parallel-group study of up to 9 weeks in duration. Seven days of QID single-blind placebo administration (via MDI) was followed by 56 days of QID double-blind active treatment. Following the run-in period, each subject was randomized to one of the following three treatments: levalbuterol HFA MDI 90 mcg (2 actuations of 45 mcg), racemic albuterol HFA MDI 180 mcg (2 actuations of 90 mcg), or placebo (2 actuations). Subjects were randomized in a 2:1:1 ratio of levalbuterol to racemic albuterol to placebo. In order to maintain blinding of the device, a placebo dose was administered with each treatment. 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
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: levalbuterol tartrate MDIlevalbuterol MDI 90 mcg QID |
| 2 | Active comparator | Drug: racemic albuterol MDIracemic albuterol MDI 180 mcg QID |
| 3 | Placebo comparator | Drug: PlaceboPlacebo MDI QID |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Willing and able to comply with the study procedures and visit schedules
- Male or female, at least 12 years of age
- Female subjects 12-60 years of age must have a negative serum pregnancy test at study start.
- Women of child bearing potential must be using an acceptable method of birth control
- Have a documented diagnosis of asthma for a minimum of 6 months prior to study start
Key exclusion criteria (15 listed)
- Female subject who is pregnant or lactating
- Have participated in an investigational drug study within 30 days prior to study start, or who is currently participating in another clinical trial
- Subject whose schedule prevents him or her from taking the first daily dose of study medication and/or starting study visits before 9 AM
- Subject who has travel commitments during the study that would interfere with trial measurements or compliance
- Have a history of hospitalization for asthma within 45 days prior to study start, or who is scheduled for in-patient hospitalization, including elective surgery
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 MDIAlso: Xopenex MDIlevalbuterol 90 mcg QID | Drug | 1 |
| racemic albuterol MDIracemic albuterol 180 mcg QID | Drug | 2 |
| PlaceboPlacebo MDI QID | Drug | 3 |
Primary outcome
percent change in FEV1 from visit predose averaged over the 8-week double-blind period
Time frame: Weeks 0, 4, 8
7 secondary outcomes
area under the FEV1 percent change curve from visit pre-dose and from study baseline curves averaged over the double-blind period
Time frame: Weeks 0, 4, 8
peak percent change in FEV1 from study baseline
Time frame: Weeks 0, 4, 8
peak change in FEV1 from visit predose
Time frame: Weeks 0, 4, 8
peak percent of predicted FEV1
Time frame: Weeks 0, 4, 8
area under the FEV1 curve (AUC)
Time frame: Weeks 0, 4, 8
peak change and peak percent change in FEF25-75% from visit predose
Time frame: Weeks 0, 4, 8
peak change and peak percent change in FVC from visit predose
Time frame: Weeks 0, 4, 8
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.
63 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 MDI and racemic albuterol MDI in people with Asthma, run by Sumitomo Pharma America, Inc. at 63 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 9 inclusion and 15 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 63 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?
percent change in FEV1 from visit predose averaged over the 8-week double-blind period (time frame: Weeks 0, 4, 8). 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; AzTrials last refreshed its copy on 8 Nov 2026.