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AsthmaPhase 3NCT00064389

Long Term Safety Study of Levalbuterol and Racemic Albuterol in Subjects Twelve Years of Age and Older With Asthma

A Phase 3 study testing levalbuterol tartrate HFA MDI and racemic albuterol in people with Asthma, run by Sumitomo Pharma America, Inc. at 96 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the safety of levalbuterol as compared to racemic albuterol based on the frequencies of adverse events reporting during a 12-month period of chronic dosing of adolescent and adult subjects with asthma. 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 HFA MDI and racemic albuterol
Could I receive a placebo?
No, everyone receives an active treatment
How many people
746 participants
Where
96 sitesin 2 countries
Study dates
Jan 2003to Jul 2005
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 study procedures and visit schedules
  • Females 12-60 yrs must have a negative serum pregnancy test at study start
  • Women of child bearing potential must use acceptable method of birth control throughout study
  • Confirmed diagnosis of asthma minimum of 6 mos. prior to study start
  • Have stable baseline asthma and have been using B-adrenergic agonist, and/or anti-asthma anti-inflammatory meds, and/or OTC asthma meds. >6 mos. prior to study start
  • In good health with exception of reversible airways disease and not suffering from any chronic condition that might affect their respiratory function
Show all 10Show fewer
  • Had chest X-ray w/in 12 mos. prior to randomization that is not diagnostic of pneumonia, atelectasis, pulmonary fibrotic disease, pneumothorax, chronic obstructive pulmonary disease etc.
  • Subject rolling over from either Sepracor study 051-353 or 051-355 must have successfully completed the study
  • Subject who is not immediately rolled over from Sepracor study 051-353 or 051-355 must wait >30 days and will be regarded as a de novo subject
  • Able to complete daily diary cards and medical event calendars reliably, understand dosing instructions, demonstrate how to use the MiniWright PEF meter. Minor subjects must have a parent/legal guardian assist them during the study with these activities

Who cannot join

  • Female who is pregnant or lactating
  • Participated in investigational drug study w/in 30 days prior to study start, or currently participating in another clinical trial, other than Sepracor studies 051-353 or 051-355
  • Subject who early terminated from Sepracor study 051-353 or 051-355
  • Subject whose schedule prevents him or her from taking the first daily dose of study medication and/or starting study visits before 10 AM
  • Have travel commitments during the study that would interfere with trial measurements and/or compliance
  • History of hospitalization for asthma w/in 45 days prior to study start, or scheduled for in-patient hospitalization, including elective surgery during the trial
Show all 16Show fewer
  • Subject with a known sensitivity to levalbuterol or racemic albuterol, or any of the excipients contained in any of these formulations
  • Subject using any prescription drug with which albuterol sulfate 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 or may interfere with the successful completion of this protocol
  • History of substance abuse or drug abuse within 12 months preceding V1
  • Subject with >10 pack/yr 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

96 sites in 2 countries.

96 sites in 2 countries

United States91 sites

  • Lovelace Scientific Resources

    Albuquerque, New Mexico, 87108

  • Office of Constantine Saadeh

    Amarillo, Texas, 79106

  • Regional Allergy & Asthma Consultants

    Asheville, North Carolina, 28801

  • Family Allergy & Asthma Center, PC

    Atlanta, Georgia, 30342

  • Allergy & Asthma Clinical of Central Texas

    Austin, Texas, 78749

  • Pulmonary Medical Research of NY

    Bay Shore, New York, 11706

  • Bellevue Pediatric Associates

    Bellevue, Pennsylvania, 15202

  • Jefferson Clinic PC

    Birmington, Alabama, 35233

  • Sneeze, Wheeze and Itch, LLC

    Bloomington, Illinois, 61761

  • Neem Research Group of Charleston

    Charleston, South Carolina, 29407

  • Charlotte Lung & Health Center

    Charlotte, North Carolina, 28207

  • Neem Research Group, Inc.

    Charlotte, North Carolina, 28262

  • Asthma Institute

    Chattanooga, Tennessee, 37421

  • Delaware Valley Institute for Clinical Research

    Cherry Hill, New Jersey, 08003

  • Rush Presbyterian - St. Luke's Medical Center

    Chicago, Illinois, 60612

  • Sterling Research Group

    Cincinnati, Ohio, 45219

  • New Horizons Clinical Research

    Cincinnati, Ohio, 45241

  • Neem Research Group Inc.

    Columbia, South Carolina, 29201

  • Optimed Research LLC

    Columbus, Ohio, 43235

  • The Allergy & Asthma Clinic Research Center

    Conyers, Georgia, 30013

  • Integrated Research Group

    Corona, California, 92506

  • Asthma & Allergy Associates, PC

    Cortland, New York, 13045

  • Northshore Medical Research

    Covington, Louisiana, 70433

  • Office of Constantine Falliers, MD

    Denver, Colorado, 80209

  • Henry Ford Hospital & Medical Centers

    Detroit, Michigan, 48202

  • Valley Clinical Research Center

    Easton, Pennsylvania, 18045

  • Northern California Research Corp

    Fair Oaks, California, 95628

  • Allergy & Asthma Care Center

    Fargo, North Dakota, 58104

  • Hurley Child and Adolescent Asthma Center

    Flint, Michigan, 45832

  • Office of Gary Richmond, MD

    Fort Lauderdale, Florida, 33316

  • CNS Clinical Trials

    Fort Myers, Florida, 33907

  • UTX Medical

    Galveston, Texas, 00000

  • Children's Asthma Respiratory & Exercise Specialists

    Glenview, Illinois, 60025

  • Allergy, Asthma, and Sinus Center F.C.

    Greenfield, Wisconsin, 53228

  • Allergic Disease & Asthma Center, PA

    Greenville, South Carolina, 29607

  • Cornerstone Research Care

    High Point, North Carolina

  • Breco Research

    Houston, Texas, 77024

  • Breath of Life Research Institute

    Houston, Texas, 77054

  • Clinical Trials of North Houston

    Houston, Texas, 77070

  • Clinical Research Center of Indiana

    Indianapolis, Indiana, 46208

  • Allergy, Asthma, Immunology Services, LLC

    Jefferson City, Missouri, 65101

  • FPA Clinical Research

    Kissimmee, Florida, 34741

  • The Allergy Associates

    Knoxville, Tennessee, 37917

  • Allergy, Asthma and Dermatology Research Center

    Lake Oswego, Oregon, 97035

  • Allergy, Asthma & Immunology Associates, PC

    Lincoln, Nebraska, 68505

  • Allergy, Asthma & Respiratory Care Center

    Long Beach, California, 90806

  • Orlando Clinic for Asthma & Respiratory Diseases

    Longwood, Florida, 32750

  • Allergy & Asthma of Northern NM

    Los Alamos, New Mexico, 87544

  • Madera Family Medical Group

    Madera, California, 93637

  • Medford Medical Clinic, LLP

    Medford, Oregon, 97504

  • Allergy Sinus Asthma Research Institute

    Miami, Florida, 33173

  • Florida Center for Alergy & Asthma Research

    Miami, Florida, 33176

  • Milwaukee Medical Clinic

    Milwaukee, Wisconsin, 53209

  • Clinical Research Institute

    Minneapolis, Minnesota, 55402

  • Montana Medical Research, LLC

    Missoula, Montana, 59804

  • Pulmonary Associates Research Division

    Mobile, Alabama, 36608

  • Montgomery Pulmonary Consultants

    Montgomery, Alabama, 36111

  • Central Texas Health Research

    New Braunfels, Texas, 78130

  • Hampton Roads Center for Clinical Research

    Norfolk, Virginia, 23502

  • Allergy, Asthma & Clinical Research Center

    Oklahoma City, Oklahoma, 73120

  • Consultants in Pulmonary Medicine

    Olathe, Kansas, 66061

  • Heartland Clinical Research Inc.

    Omaha, Nebraska, 68134

  • Office of Meera Dewan, MD

    Omaha, Nebraska, 68144

  • Clinical Trials of Orange County, Inc.

    Orange, California, 92868

  • Orlando Clinical Research Center

    Orlando, Florida, 32806

  • Center of Research Excellence, LLC

    Oxford, Alabama, 36203

  • Allergy & Asthma Research of NJ, Inc.

    Philadelphia, Pennsylvania, 19115

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • Lovelace Scientific Resources

    Phoenix, Arizona, 85016

  • Pulmonary Associates of Richmond Inc.

    Richmond, Virginia, 23225

  • Virginia Adult & Pediatric Allergy & Asthma PC

    Richmond, Virginia, 23229

  • National Clinical Research

    Richmond, Virginia, 23294

  • Midwest Chest Consultants, PC

    Saint Charles, Missouri, 63301

  • Lung Diagnostics

    San Antonio, Texas, 78229

  • Institute of Healthcare Assessment, Inc.

    San Diego, California, 92120

  • Aeroallergy Research

    Savannah, Georgia, 31046

  • Advanced Clinical Concepts

    Shillington, Pennsylvania, 19607

  • South Bend Clinic

    South Bend, Indiana, 46617

  • The Physician's Clinic of Spokane

    Spokane, Washington, 99204

  • Cardinal Respiratory, PC

    Springfield, Illinois

  • Washington University School of Medicine, Division of Allergy & Immunology

    St Louis, Missouri, 63110

  • Office of Michael Marcus, MD

    Staten Island, New York, 10304

  • Center for Clinical Research

    Taunton, Massachusetts, 02780

  • Clinical Research Center of Allergy & Asthma Consultants

    Tinton Falls, New Jersey, 07701

  • Office of Richard Castaldo

    Tonawanda, New York, 14150

  • Alta Clinical Research, LLC

    Tucson, Arizona, 85745

  • Allergic Diseases, S.C.

    West Allis, Wisconsin, 53227

  • Westlake Medical Research, Inc.

    Westlake Village, California, 91361

  • Institute for Asthma & Allergy, PC

    Wheaton, Maryland

  • Heartland Research Associates

    Wichita, Kansas, 67207

  • Carolina MedTrials, LLC

    Winston-Salem, North Carolina, 27103

Other trials in United States

Canada5 sites

  • Clinical Research Group

    Mississauga, Ontario, L5B 1N1

  • Niagara Clinical Research, Inc.

    Niagara Falls, Ontario, L2E 7H1

  • Primary Care Lung Clinic

    Toronto, Ontario, M6H 3M2

  • Trial Management Group

    Vancouver, British Columbia, V5K 1Z9

  • St. Boniface General Hospital

    Winnipeg, Manitoba, R2H 2A6

Other trials in Canada

About this study

The purpose of this study is to evaluate the safety of levalbuterol as compared to racemic albuterol based on the frequencies of adverse events reporting during a 12-month period of chronic dosing of adolescent and adult subjects with asthma.

Read the detailed description

This was a randomized, open-label, active controlled, multicenter, parallel-group safety study in subjects 12 years of age and older with asthma. Subjects of appropriate age who completed the Phase III levalbuterol HFA MDI trials (Studies 051-353 or 051-355) were eligible to participate. Studies 051-353 and 051-355, both entitled "An Efficacy and Safety Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older with Asthma" were multicenter, randomized, double-blind, placebo- and active-controlled, parallel-group studies of up to nine weeks in duration (a one-week single-blind placebo run in period followed by an eight-week double-blind treatment period). Subjects who completed Studies 051 353 and 051 355 but who were not immediately eligible to rollover into the current study could also participate but only after a 30-day washout. New subjects and subjects who participated in the Phase III trials who were not immediately eligible (ie, had a >30-day washout) were considered to be de novo subjects.Study participation included 10 study visits over a 12 month period.

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 HFA MDI, racemic albuterol
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 HFA MDIDrug

    Also called Xopenex HFA MDI

    levalbuterol MDI 90 mcg QID

  • racemic albuterolDrug

    racemic albuterol HFA MDI 180 mcg QID

Study groups in NCT00064389
Study groupRoleWhat they receive
1Experimentallevalbuterol 90 mcg MDI QID
Receives: Drug: levalbuterol tartrate HFA MDI
2Active comparatorracemic albuterol HFA MDI 180 mcg QID
Receives: Drug: racemic albuterol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. incidence of post-randomization adverse events

    Measured: Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53

Secondary outcomes (13)

  1. rate of discontinuations due to adverse events

    Measured: Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53

  2. time-to-selected adverse events (AEs with an incidence ≥5%)

    Measured: Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53

  3. asthma attacks, asthma adverse events, and expanded-definition asthma events

    Measured: Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53

  4. clinical laboratory values

    Measured: Weeks -1, 0, 10, 11, 26, 27, 43, 44, 52, 53

  5. vital signs (blood pressure, heart rate, respiration rate, and body temperature)

    Measured: Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 26, 27, 34, 35, 43, 44, 52, 53

  6. ECG parameters

    Measured: Weeks -1, 0, 1, 10, 11, 26, 27, 43, 44, 52, 53

  7. physical examinations

    Measured: Weeks -1, 0, 26, 27, 52, 53

  8. rescue medication, and daytime asthma control days

    Measured: Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53

  9. FEV1, FVC, FEF25-75%, peak expiratory flow

    Measured: Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 26, 27, 34, 35, 43, 44, 52, 53

  10. Asthma Quality of Life Questionnaire (AQLQ)

    Measured: Weeks 0, 26, 27, 52, 53

  11. subject and physician global evaluations

    Measured: Weeks 26, 27, 52, 53

  12. (S) and (R) albuterol plasma concentrations

    Measured: Weeks -1, 0, 10, 11, 26, 27, 43, 44, 52, 53

  13. subject assessment of study inhaler device performance

    Measured: Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2003 (estimated)
  2. Study startJan 2003
  3. Primary completionJul 2005
  4. Study completionJul 2005

Resources

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
None (open label)
Enrolment
746 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00064389
Sponsor's protocol ID
051-356
Status last verified
Feb 2012
First submitted
8 Jul 2003
Last updated
22 Feb 2012
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing levalbuterol tartrate HFA MDI and racemic albuterol in people with Asthma, run by Sumitomo Pharma America, Inc. at 96 sites in 2 countries.

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 10 inclusion and 16 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 96 sites in United States, Canada. 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?

incidence of post-randomization adverse events (time frame: Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00064389.

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.

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