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Long Term Safety Study of Levalbuterol and Racemic Albuterol in Subjects Twelve Years of Age and Older with Asthma Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on Long Term Safety Study of Levalbuterol and Racemic Albuterol in Subjects Twelve Years of Age and Older with Asthma conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Long Term Safety Study of Levalbuterol and Racemic Albuterol in Subjects Twelve Years of Age and Older with Asthma Clinical research trials and Long Term Safety Study of Levalbuterol and Racemic Albuterol in Subjects Twelve Years of Age and Older with Asthma healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including Long Term Safety Study of Levalbuterol and Racemic Albuterol in Subjects Twelve Years of Age and Older with Asthma. Long Term Safety Study of Levalbuterol and Racemic Albuterol in Subjects Twelve Years of Age and Older with Asthma Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a Long Term Safety Study of Levalbuterol and Racemic Albuterol in Subjects Twelve Years of Age and Older with Asthma clinical trial. Test subjects oftentimes recieve the best healthcare possible for their Long Term Safety Study of Levalbuterol and Racemic Albuterol in Subjects Twelve Years of Age and Older with Asthma condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.

Home > "L" Clinical Trials Conditions > Long Term Safety Study of Levalbuterol and Racemic Albuterol in Subjects Twelve Years of Age and Older with Asthma

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



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

For Condition: Asthma
Status: Recruiting
Sponsor(s): Sepracor, Inc. ,
Synopsis: 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety Study
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - Give written informed consent prior to participation. Females must sign Women of Childbearing Potential Addendum - Willing and able to comply with study procedures and visit schedules - Females 12-60 yrs must have a negative serum pregnancy test at Visit 1 (V1) - Women of child bearing potential must use acceptable method of birth control throughout study - Confirmed diagnosis of asthma minimum of 6 mos. prior to V1 - At V1, must demonstrate baseline FEV1 within >50% & <80% predicted for height/age/gender/race - Following abstinence from asthma meds must demonstrate >12% reversibility of airflow obstruction within 15-30 mins. following inhalation racemic albuterol MDI - 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 V1 - In good health with exception of reversible airways disease and not suffering from any chronic condition that might affect their respiratory function - 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 Exclusion Criteria - Subject who is expected to require any disallowed medications - Female who is pregnant or lactating - Participated in investigational drug study w/in 30 days prior to V1, 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 V1, or scheduled for in-patient hospitalization, including elective surgery during the trial - 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 - Subject with clinically significant abnormalities that may interfere with the metabolism or excretion of the study drug - 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 V1 - 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 V1 - Any clinically significant abnormal laboratory values - Any clinically significant abnormal 12-lead ECG that may jeopardize the subject’s ability to complete the study - Subject who is a staff member or relative of a staff member
Total Enrollment: 

Location and Contact Information:

Orlando Clinical Research Center *Recruiting*
Orlando,  Florida,  32806
United States
Recruiting Patty  Ford 407-240-7878

Carolina MedTrials, LLC *No longer recruiting*
Winston Salem,  North Carolina,  27103
United States
No longer recruiting  

Lung Diagnostics *Recruiting*
San Antonio,  Texas,  78229
United States
Recruiting Jill  Twardowski 210-692-7157

Heartland Research Associates *Recruiting*
Wichita,  Kansas,  67207
United States
Recruiting Holli  Herndon 316-689-6670

Center for Clinical Research *Recruiting*
Taunton,  Massachusetts,  02780
United States
Recruiting Dana  Vieira 508-880-8737

Neem Research Group, Inc. *Recruiting*
Charlotte,  North Carolina,  28262
United States
Recruiting Marilyn  Graham 704-330-8748

Alta Clinical Research, LLC *No longer recruiting*
Tucson,  Arizona,  85745
United States
No longer recruiting  

Cornerstone Research Care *No longer recruiting*
High Point,  North Carolina, 
United States
No longer recruiting  

Pulmonary Associates Research Division *Recruiting*
Mobile,  Alabama,  36608
United States
Recruiting Michele  Hemphill 251-633-8880

The Allergy Associates *Recruiting*
Knoxville,  Tennessee,  37917
United States
Recruiting Laura  Livingston 865-523-0303

Heartland Clinical Research Inc. *Recruiting*
Omaha,  Nebraska,  68134
United States
Recruiting Laurie  Dubois 402-502-9364

The Allergy & Asthma Clinic Research Center *Recruiting*
Conyers,  Georgia,  30013
United States
Recruiting Carrie  Spillers 770-760-8287

Central Texas Health Research *Recruiting*
New Braunfels,  Texas,  78130
United States
Recruiting Shealynn  Korpi 830-609-0900

Asthma & Allergy Associates, PC *Recruiting*
Cortland,  New York,  13045
United States
Recruiting Ann  Lawrence 607-753-9604

Allergy, Asthma & Respiratory Care Center *Recruiting*
Long Beach,  California,  90806
United States
Recruiting Patty  Estudillo 562-997-8850

Charlotte Lung & Health Center *Recruiting*
Charlotte,  North Carolina,  28207
United States
Recruiting Edy  Gary 704-342-8143

South Bend Clinic *Recruiting*
South Bend,  Indiana,  46617
United States
Recruiting Julia  Egan 574-237-9337

Clinical Research Center of Indiana *Recruiting*
Indianapolis,  Indiana,  46208
United States
Recruiting Artie  McBuddy 317-924-8297

Northshore Medical Research *Recruiting*
Covington,  Louisiana,  70433
United States
Recruiting Kelli  Cannon 985-892-9230

Pulmonary Associates of Richmond Inc. *Recruiting*
Richmond,  Virginia,  23225
United States
Recruiting Laura  Lincoln 804-323-7002

Breco Research *Recruiting*
Houston,  Texas,  77024
United States
Recruiting Patricia  Mendoza 713-973-6993

Office of Michael Marcus, MD *Recruiting*
Staten Island,  New York,  10304
United States
Recruiting Arlene  Viviano 718-980-5864

Valley Clinical Research Center *No longer recruiting*
Easton,  Pennsylvania,  18045
United States
No longer recruiting  

Family Allergy & Asthma Center, PC *Recruiting*
Atlanta,  Georgia,  30342
United States
Recruiting Eleanor  Seale 404-255-8080

Regional Allergy & Asthma Consultants *Recruiting*
Asheville,  North Carolina,  28801
United States
Recruiting Carolyn  Gallina 828-253-3382

Clinical Trials of North Houston *Recruiting*
Houston,  Texas,  77070
United States
Recruiting Nelva  Baker 832-912-1188

Lovelace Scientific Resources *Recruiting*
Phoenix,  Arizona,  85016
United States
Recruiting Barbara  Gibbons 602-553-4070

Midwest Chest Consultants, PC *Recruiting*
St. Charles,  Missouri,  63301
United States
Recruiting Marcia  Gaddy 636-946-1650

Clinical Research Institute *Recruiting*
Minneapolis,  Minnesota,  55402
United States
Recruiting Cindy  Quintard 612-349-3760

Medford Medical Clinic, LLP *Recruiting*
Medforo,  Oregon,  97504
United States
Recruiting Flora  Garcia 541-734-3657

Clinical Trials of Orange County, Inc. *Recruiting*
Orange,  California,  92868
United States
Recruiting Alma  Carrasco-Gomez 714-744-2773

New Horizons Clinical Research *Recruiting*
Cincinnati,  Ohio,  45241
United States
Recruiting Wayne  Shupp 513-769-2767

Hurley Child and Adolescent Asthma Center *Recruiting*
Flint,  Michigan,  45832
United States
Recruiting Julie  Campe 810-237-6775

Allergy, Asthma, Immunology Services, LLC *Recruiting*
Jefferson City,  Missouri,  65101
United States
Recruiting Penny  Huston 573-556-7726

Office of Gary Richmond, MD *Recruiting*
Ft. Lauderdale,  Florida,  33316
United States
Recruiting Verne  Appleby 954-524-2250

Delaware Valley Institute for Clinical Research *Recruiting*
Cherry Hill,  New Jersey,  08003
United States
Recruiting Kathi  Ference 609-424-1777

Allergy Sinus Asthma Research Institute *No longer recruiting*
Miami,  Florida,  33173
United States
No longer recruiting  

Neem Research Group Inc. *Recruiting*
Columbia,  South Carolina,  29201
United States
Recruiting Peggy  Johnson 803-254-4295

Jefferson Clinic PC *Recruiting*
Birmington,  Alabama,  35233
United States
Recruiting Chris  Dease 205-930-3292

FPA Clinical Research *Recruiting*
Kissimmee,  Florida,  34741
United States
Recruiting Troy  Koenig 407-846-6625

Consultants in Pulmonary Medicine *Recruiting*
Olathe,  Kansas,  66061
United States
Recruiting Jeanne  Zirkle 913-829-0446

Office of Meera Dewan, MD *Recruiting*
Omaha,  Nebraska,  68144
United States
Recruiting Tara  Walie 402-330-4770

Office of Richard Castaldo *Recruiting*
Tonawanda,  New York,  14150
United States
Recruiting Jamie  Evan 716-743-5454

Westlake Medical Research, Inc. *Recruiting*
Westlake Village,  California,  91361
United States
Recruiting Pam  Brady 805-496-3322

Primary Care Lung Clinic *Recruiting*
Toronto,  Ontario,  M6H 3M2
Canada
Recruiting Vesant  Solanki 416-652-9336

Office of Constantine Saadeh *No longer recruiting*
Amarillo,  Texas,  79106
United States
No longer recruiting  

St. Boniface General Hospital *Recruiting*
Winnipeg,  Manitoba,  R2H 2A6
Canada
Recruiting Shauna  Leeson 204-237-2705

Niagara Clinical Research, Inc. *No longer recruiting*
Niagara Falls,  Ontario,  L2E 7H1
Canada
No longer recruiting  

Neem Research Group of Charleston *Recruiting*
Charleston,  South Carolina,  29407
United States
Recruiting Kristin  Dunn 843-766-5045

Allergic Disease & Asthma Center, PA *Recruiting*
Greenville,  South Carolina,  29607
United States
Recruiting Linda  Gregory 864-627-3800

Florida Center for Alergy & Asthma Research *Recruiting*
Miami,  Florida,  33176
United States
Recruiting Rachel  Hewett 305-273-2988

Breath of Life Research Institute *Recruiting*
Houston,  Texas,  77054
United States
Recruiting Dawn  Fanguy 281-398-7353

Integrated Research Group *Recruiting*
Corona,  California,  92506
United States
Recruiting Sheina  Santos 909-737-1561

Rush Presbyterian - St. Luke's Medical Center *Recruiting*
Chicago,  Illinois,  60612
United States
Recruiting Janet  Renteria 312-563-2647

Allergic Diseases, S.C. *Recruiting*
West Allis,  Wisconsin,  53227
United States
Recruiting Susan  Sowinski 414-545-1111

Allergy, Asthma and Dermatology Research Center *Recruiting*
Lake Oswego,  Oregon,  97035
United States
Recruiting Lisa  Byrd 503-534-2622

The Physician's Clinic of Spokane *Recruiting*
Spokane,  Washington,  99204
United States
Recruiting Melodie  Close 509-353-4269

Bellevue Pediatric Associates *Recruiting*
Bellevue,  Pennsylvania,  15202
United States
Recruiting Jason  Krahnke 412-761-1190

Northern California Research Corp *Recruiting*
Fair Oaks,  California,  95628
United States
Recruiting Laurie  Johnson 916-961-7593

Pulmonary Medical Research of NY *Recruiting*
Bay Shore,  New York,  11706
United States
Recruiting Diana  Mauceri 631-665-7392

Center of Research Excellence, LLC *Recruiting*
Oxford,  Alabama,  36203
United States
Recruiting Amanda  Gregory 256-835-1909

Henry Ford Hospital & Medical Centers *Recruiting*
Detroit,  Michigan,  48202
United States
Recruiting Michelle  Whitican 313-916-3678

Allergy & Asthma Care Center *Recruiting*
Fargo,  North Dakota,  58104
United States
Recruiting Cheri  Welk 701-232-2388

Asthma Institute *Recruiting*
Chattanooga,  Tennessee,  37421
United States
Recruiting Joice  Nash 423-499-4100

Hampton Roads Center for Clinical Research *Recruiting*
Norfolk,  Virginia,  23502
United States
Recruiting Robin  Roth 757-461-3633

Allergy & Asthma of Northern NM *Recruiting*
Los Alamos,  New Mexico,  87544
United States
Recruiting Marlene  Muller 505-662-4351

Trial Management Group *Recruiting*
Vancouver,  British Columbia,  V5K 1Z9
Canada
Recruiting Janet  McKenney 604-253-3166

Allergy, Asthma & Immunology Associates, PC *Recruiting*
Lincoln,  Nebraska,  68505
United States
Recruiting Marge  Abelbeck 402-464-5969

Advanced Clinical Concepts *Recruiting*
Shillington,  Pennsylvania,  19607
United States
Recruiting Stacy  Kohler 610-929-9484

UTX Medical *No longer recruiting*
Galveston,  Texas,  00000
United States
No longer recruiting  

Orlando Clinic for Asthma & Respiratory Diseases *Recruiting*
Longwood,  Florida,  32750
United States
Recruiting Mary  Johnson 407-265-7775

CNS Clinical Trials *No longer recruiting*
Ft. Myers,  Florida,  33907
United States
No longer recruiting  

Washington University School of Medicine, Division of Allergy & Immunology *Recruiting*
St. Louis,  Missouri,  63110
United States
Recruiting Sara  Kukujian 314-454-5981

Allergy, Asthma, and Sinus Center F.C. *Recruiting*
Greenfield,  Wisconsin,  53228
United States
Recruiting Deborah  Rankin 414-529-8500

Temple University Hospital *No longer recruiting*
Philadelphia,  Pennsylvania,  19140
United States
No longer recruiting  

Allergy, Asthma & Clinical Research Center *Recruiting*
Oklahoma City,  Oklahoma,  73120
United States
Recruiting Tammy  Ernst 405-752-0393

Montgomery Pulmonary Consultants *No longer recruiting*
Montgomery,  Alabama,  36111
United States
No longer recruiting  

Institute of Healthcare Assessment, Inc. *Recruiting*
San Diego,  California,  92120
United States
Recruiting Bob  Halterman 619-582-5564

Aeroallergy Research *Recruiting*
Savannah,  Georgia,  31046
United States
Recruiting Susie  Kitchen 912-354-6190

Milwaukee Medical Clinic *Recruiting*
Milwaukee,  Wisconsin,  53209
United States
Recruiting Kris  Kurth 414-351-7835

Optimed Research LLC *No longer recruiting*
Columbus,  Ohio,  43235
United States
No longer recruiting  

Montana Medical Research, LLC *No longer recruiting*
Missoula,  Montana,  59804
United States
No longer recruiting  

Sterling Research Group *Recruiting*
Cincinnati,  Ohio,  45219
United States
Recruiting Cindy  Wright 513-381-4100

Cardinal Respiratory, PC *No longer recruiting*
Springfield,  Illinois, 
United States
No longer recruiting  

Office of Constantine Falliers, MD *No longer recruiting*
Denver,  Colorado,  80209
United States
No longer recruiting  

Virginia Adult & Pediatric Allergy & Asthma PC *Recruiting*
Richmond,  Virginia,  23229
United States
Recruiting Jean  Ellis 804-282-2471

Allergy & Asthma Research of NJ, Inc. *Recruiting*
Philadelphia,  Pennsylvania,  19115
United States
Recruiting Nicole  Blatstein 215-677-4433

Lovelace Scientific Resources *Recruiting*
Albuquerque,  New Mexico,  87108
United States
Recruiting Karen  Seuntjens 505-348-9371

Allergy & Asthma Clinical of Central Texas *No longer recruiting*
Austin,  Texas,  78749
United States
No longer recruiting  

Clinical Research Center of Allergy & Asthma Consultants *No longer recruiting*
Tinton Falls,  New Jersey,  07701
United States
No longer recruiting  

National Clinical Research *Recruiting*
Richmond,  Virginia,  23294
United States
Recruiting Karen  Hojnowski 804-672-2995

Children's Asthma Respiratory & Exercise Specialists *Recruiting*
Glenview,  Illinois,  60025
United States
Recruiting Kathy  Wolf 847-998-3434

Clinical Research Group *Recruiting*
Mississauga,  Ontario,  L5B 1N1
Canada
Recruiting Rupinder  Gogia 905-566-1200

Madera Family Medical Group *Recruiting*
Madera,  California,  93637
United States
Recruiting Rose  Shafi 559-673-3000

Sneeze, Wheeze and Itch, LLC *Recruiting*
Bloomington,  Illinois,  61761
United States
Recruiting Karri  Eimer 309-452-0995

Institute for Asthma & Allergy, PC *No longer recruiting*
Wheaton,  Maryland, 
United States
No longer recruiting  


Additional Information:
Study ID Numbers:
  051-356; 
Study Start Date: 
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00064389

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

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