According to the World Health Organization, each year , people die from asthma worldwide. The disease is characterized by shortness of breath, wheezing, tightness in the chest, and a cough that lasts more than a week. COPD is a common chronic lung disease and a leading cause of mortality worldwide, with 2. Since both asthma and COPD are chronic conditions, the goal of treatment is management and improvement of quality of life, rather than cure.
The effectiveness of Foradil as a treatment for asthma was evaluated in five key trials involving more than 7, subjects, including over 1, mild to moderate asthmatics. In these placebo-controlled trials, Foradil was administered in 12 and 24 mcg twice daily doses. Overall, these studies demonstrated both dosages of Foradil to be significantly better than placebo at improving lung function and quality of life in asthmatic subjects.
Foradil provided subjects with clinically significant bronchodilation for a 12 hour period. Current evidence of, or past physician assessment of, chronic bronchitis, emphysema, or chronic obstructive pulmonary disease. Exercise induced asthma as the only asthma-related diagnosis not requiring daily asthma control medicine. Suspected or documented bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved at randomization.
Any asthma exacerbation requiring systemic corticosteroids within 30 days of randomization or more than 4 separate exacerbations in the 12 months preceding randomization. Two or more hospitalizations for greater than 24 hours duration for treatment of asthma in the 12 months preceding randomization.
History of hypersensitivity to any beta2-agonist, sympathomimetic drug, inhaled corticosteroids, or systemic corticosteroid therapy or any component of the possible study treatments in this trial, including severe milk protein hypersensitivity. Use of anti-IgE e.
Use of a potent CYP3A4 inhibitor within 4 weeks of randomization e. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials. More Information. Asthma formoterol fumarate Foradil inhaled corticosteroid fluticasone propionate safety. National Library of Medicine U. National Institutes of Health U.
Department of Health and Human Services. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Persistent Asthma. Phase 4. I agree to the Terms. I agree to the Privacy Statement. Newsletter Signup.
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The product is manufactured at SkyePharma's Lyon facility in France. SkyePharma is receiving fees, development costs and milestone payments from Novartis.
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