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Efficacy and Safety of Fexofenadine in Mild to Moderate Persistent Asthma Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Efficacy and Safety of Fexofenadine in Mild to Moderate Persistent Asthma conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Efficacy and Safety of Fexofenadine in Mild to Moderate Persistent Asthma Clinical research trials and Efficacy and Safety of Fexofenadine in Mild to Moderate Persistent Asthma medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Efficacy and Safety of Fexofenadine in Mild to Moderate Persistent Asthma. Efficacy and Safety of Fexofenadine in Mild to Moderate Persistent Asthma Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Efficacy and Safety of Fexofenadine in Mild to Moderate Persistent Asthma clinical trial. Participants oftentimes recieve the finest healthcare available for their Efficacy and Safety of Fexofenadine in Mild to Moderate Persistent Asthma condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "E" Clinical Trials Conditions > Efficacy and Safety of Fexofenadine in Mild to Moderate Persistent Asthma  Efficacy and Safety of Fexofenadine in Mild to Moderate Persistent Asthma
Efficacy and Safety of Fexofenadine in Mild to Moderate Persistent Asthma
For Condition: Asthma
Status: No longer recruiting
Sponsor(s): Aventis Pharmaceuticals ,
Synopsis: The purpose of this study is to investigate the efficacy and safety of fexofenadine 120mg BID compared to placebo in the treatment of subjects with mild to moderate persistent asthma
Details: The incidence of respiratory allergy in the US has increased gradually over the past several years, and current estimates suggest that allergic rhinitis and bronchial asthma affect approximately 20% and 5% of the population, respectively. Rhinitis and asthma frequently coexist, and large-scale population surveys indicate that up to 38% of subjects with rhinitis have asthma, and up to 78% of subjects with asthma have chronic nasal symptoms. Safety concerns with the increased use of inhaled corticosterioids, the heterogeneity of the disease, and poor compliance with asthma medication regimens, point to the need for the development of safe and convenient oral therapies for asthma. Histamine is an important chemical mediator of inflammation in asthma. The benefits of antihistamine treatment in patients with mild to moderate asthma have been well documented, however their clinical use has been previously limited due to the high doses required for efficacy and their associated side effects including sedation and cognitive impairment.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 12 Years/80 Years
Genders: Both
Protocol Entry Criteria: Inclusion criteria: - Males and non-pregnant, non-breastfeeding females 12 through 80 years of age - FEV1 in the context of this study is greater than 60% and not less or equal to 87% of predicted values at Visit 1 or Visit 2 (and no short-acting agent beta-agonist use within 6 hours prior to spirometry) - Improvement in FEV1 of at least 12% of predicted value and at least 200ml within 15 to 30 minutes of inhaling 2 puffs of albuterol 90mcg/actuation demonstrated at study entry OR documented during the previous 12 months at the study site. - Use of a short-acting, beta-agonist inhaler to treat asthma symptoms on an average of at least 2 days per week during the previous 2 weeks (greater than or equal to 4 days total during the previous 2 weeks, excluding prophylactic use) Exclusion criteria: - Otherwise healthy
Total Enrollment: 1000
Location and Contact Information:
Aventis Pharmaceuticals Inc.
Bridgewater, New Jersey, 08807
United States
Additional Information:
Study ID Numbers: M016455P/3001;
Study Start Date: January 2002
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00044811
Other Asthma Studies:
1. Efficacy and Safety of Fexofenadine in Mild to Moderate Persistent Asthma
2. Honolulu Heart Program
3. Isocyanate Antigens and T Cells That Cause Asthma
4. Magnesium and Asthma - Clinical Trials
5. Epidemiology of Airway Responsiveness
Related Studies:
Other Asthma Clinical Trials
Other New Jersey Clinical Trials
Other Bridgewater Clinical Trials
Efficacy and Safety of Fexofenadine in Mild to Moderate Persistent Asthma
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