|
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
Other Asthma Studies:
1. Intervention to Improve Asthma Management/Prevention
2. Outdoor Allergen Exposure, Sensitivity, and Acute Asthma
3. The Genetics of Environmental Asthma
4. Prospective Evaluation of Airways Reactivity
5. Longitudinal Study of Asthma From Birth to Adulthood
Related Studies:
Other Asthma Clinical Trials
Other California Clinical Trials
Other Westlake Village Clinical Trials
Long Term Safety Study of Levalbuterol and Racemic Albuterol in Subjects Twelve Years of Age and Older with Asthma
|
|
|
|
|
|
|
|