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Home > "S" Clinical Trials Conditions > Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older with Asthma Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older with Asthma
Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older with Asthma
For Condition: Asthma
Status: No longer recruiting
Sponsor(s): Sepracor, Inc. ,
Synopsis: The primary objective is to investigate the efficacy of levalbuterol 90 ug (2 actuations, 45 ug each) versus placebo (2 actuations) in the treatment and prevention of bronchoconstriction in adolescent and adult subjects with asthma, with all treatments administered 4 times a day (QID).
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 12 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - Give written informed consent (IC) prior to participation. Subjects 12 to 17 years of age, IC must be signed by the subject’s parent or legal guardian. Females sign the Women of Childbearing Potential Addendum - 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 Visit 1. - 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 Visit 1 - At Visit 1, the subject must demonstrate a baseline FEV1 within >45% and <75% of predicted for their height (HT), age, gender, and race - Following abstention from medications used to treat asthma, the subject must demonstrate >12% reversibility of airflow obstruction within 15-30 mins. following inhalation of racemic albuterol MDI - 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 Visit 1 - 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. Exclusion Criteria - Subject who is expected to require any disallowed medications - Female subject who is pregnant or lactating - Have participated in an investigational drug study within 30 days prior to Visit 1, 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 Visit 1, 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 - Subject using any prescription drug with which albuterol sulfate administration 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 - History of substance abuse or drug abuse within 12 months preceding Visit 1 - Subject with greater than 10 pack year history of cigarette smoking or use of any tobacco products within 6 months of Visit 1 - 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 Visit 1 - Subject with any clinically significant abnormal laboratory values - Subject with a clinically significant abnormal 12-lead ECG that would put the subject at risk for experiencing adverse cardiac effects - Subject who is a staff member or relative of a staff member
Total Enrollment: 400
Location and Contact Information:
Aeroallergy Research Laboratories of Savannah, Inc.
Savannah, Georgia, 31406
United States
Allergic Diseases, SC
West Allis, Wisconsin, 53227
United States
National Jewish Medical & Research Center
Denver, Colorado, 80206
United States
Integrated Research Group
Corona, California, 92879
United States
Office of Clinical Research, University of Missouri-Columbia
Columbia, Missouri, 65212
United States
Henry Ford Health System
Detroit, Michigan, 48202
United States
ASTHMA, Inc.
Seattle, Washington, 98105
United States
Allergy & Asthma Medical Group of Diablo Valley, Inc.
Danville, California, 94526
United States
Office of Ronald Saff
Tallahassee, Florida, 32308
United States
PCCS
Albany, New York, 12205
United States
Raleigh Pediatric Associates
Raleigh, North Carolina, 27609
United States
Office of Neil Kao
Greenville, South Carolina, 29607
United States
Princeton Center for Clinical Research
Princeton, New Jersey, 08540
United States
Lung Diagnostics
San Antonio, Texas,
United States
PCHI
Needham, Massachusetts, 02494
United States
The Children's Mercy Hospital
Kansas City, Missouri, 64108
United States
Southern California Research Center
Viejo, California, 92691
United States
Asthma & Allergy Associates, PC
Pueblo, Colorado, 81001
United States
Breath of Life Research Institute
Houston, Texas, 77054
United States
Radiant Research Honolulu
Honolulu, Hawaii, 96814
United States
Regional Allergy & Asthma Consultants
Asheville, North Carolina, 28801
United States
Allergy Associates Research Center, LLC
Portland, Oregon, 97213
United States
Allergy & Asthma Medical Group & Research Center
San Diego, California, 92123
United States
St. Louis University
St. Louis, Missouri, 63110
United States
Allergy & Asthma Research
Eugene, Oregon, 97401
United States
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio, 45231
United States
Allergy Associates Medical Group
San Diego, California, 92120
United States
University of Maryland School of Medicine
Baltimore, Maryland,
United States
Division of Allergy & Immunology, Washington Univ School of Med
St. Louis, Missouri, 63110
United States
Pulmonary and Allergy Associates
Springfield, New Jersey, 07081
United States
Clinical Research Center of Indiana
Indianapolis, Indiana, 46208
United States
The Clinical Research Center, LLC
St. Louis, Missouri, 63141
United States
Alabama Asthma and Allergy Center
Homewood, Alabama, 35209
United States
Allergy, Asthma & Respiratory Care Center
Long Beach, California, 90806
United States
Mississippi Asthma & Allergy Clinic
Jackson, Mississippi,
United States
Children's Hospital of Pittsburgh Division of Allergy, Immunology & Infectious Diseases
Pittsburgh, Pennsylvania, 15213
United States
Center for Clinical Research
Taunton, Massachusetts, 02780
United States
AAIR Research Center
Rochester, New York, 14618
United States
Temple University Hospital
Philadelphia, Pennsylvania, 19140
United States
Clinical Research Centers of Colorado PC
Englewood, Colorado, 80112
United States
Radiant Research, Inc.
Encinitas, California, 92024
United States
Allergy & Asthma Assoc. of Santa Clara Valley Research Center
San Jose, California, 95117
United States
Allergy & Asthma Care Specialists
Metairie, Louisiana, 70006
United States
Cornerstone Research Care
High Point, North Carolina, 27262
United States
Allergy & Asthma Prevention & Treatment Center
San Diego, California, 92131
United States
Allergy & Asthma Center
Waco, Texas,
United States
Bensch Research Associates
Stockton, California, 95207
United States
Northshore Medical Research
Slidell, Louisiana, 70458
United States
Radiant Research
Charleston, South Carolina, 29407
United States
Office of Constantine Saadeh
Amarillo, Texas, 79106
United States
Pulmonary Associates of Richmond, Inc.
Richmond, Virginia, 23225
United States
Clinical Trials of Orange County
Orange, California, 92868
United States
Clinical Research Institute
Minneapolis, Minnesota, 55402
United States
Asthma & Allergy Research Associates
Chester, Pennsylvania, 19013
United States
Allergy Research Foundation, Inc.
Los Angeles, California, 90025
United States
MDC Research
Mobile, Alabama, 36607
United States
Allergy & Asthma Research Associates
Dallas, Texas, 75231
United States
Northeast Medical Research Associates, Inc.
Dartmouth, Massachusetts, 02747
United States
University of Pittsburgh Division of Pulmonary
Pittsburgh, Pennsylvania, 15213
United States
Allergy & Asthma Consultants, LLP
Mt. Pleasant, South Carolina, 29464
United States
Allergy & Asthma Specialists Medical Group
Huntington Beach, California, 92647
United States
Children's Hospital of the Kings Daughters
Norfolk, Virginia, 23507
United States
North Texas Institute for Clinical Trials
Ft. Worth, Texas, 76132
United States
Additional Information:
Study ID Numbers: 051-353;
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00073827
Other Asthma Studies:
1. Asthma Partnership for Minority Children
2. Isocyanate Antigens and T Cells That Cause Asthma
3. Ozone and Rhinovirus-Induced Disease in Asthmatics
4. Community Based Study of Adult Onset Asthma
5. Assessment of Lung Inflammation in Patients with Atopic Asthma Using Positron Emission Tomography
Related Studies:
Other Asthma Clinical Trials
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Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older with Asthma
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