SAS115359: A 6-month Study to Assess the Safety and Benefit of Inhaled Fluticasone Propionate/Salmeterol Combination Compared With Inhaled Fluticasone Propionate in the Treatment of Adolescents and Adults (12 Years of Age and Older) With Asthma.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GlaxoSmithKline
With
Parexel
Progress of Enrollment, Updated Annually: This study has been completed and the final clinical study report was submitted to the FDA in January of 2016. This is the final update, as this study is complete.
Age
12–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Provided consent to participate in the study
Male or female, 12 years of age and older
Clinical diagnosis of asthma for at least 1 year prior to the randomization
Clinic PEF of greater than or equal to 50% of predicted normal value
Subject must be appropriately using one of the treatments for asthma listed in the protocol
Subject must be able to complete the asthma control questionnaire, daily questions about asthma, and use a DISKUS inhaler
Subject must have history of at least 1 asthma exacerbation including one of the following in the year prior to randomization:
requiring treatment with systemic corticosteroids
an asthma-related hospitalization
You may not be if
History of life threatening asthma defined for this protocol as asthma episode that required intubation and/or was associated with hypercapnea requiring non-invasive ventilatory support
Concurrent respiratory disease other than asthma
Current evidence of, or ever been told by a physician that they have chronic bronchitis, emphysema, or chronic obstructive pulmonary disease.
Exercise induced asthma (as the only asthma-related diagnosis) not requiring daily asthma control medicine
Presence of a bacterial or viral respiratory infection that is not resolved at randomization
An asthma exacerbation requiring systemic corticosteriods within 4 weeks of randomization or more than 4 separate exacerbations in the 12 months preceding randomization
More than 2 hospitalizations for treatment of asthma in the 12 months preceding randomization
Subject must not meet unstable asthma severity criteria as listed in the protocol
Potent cytochrome P450 3A4 (CYP3A4) inhibitors within the last 4 weeks (e.g., ritonavir, ketoconazole, itraconzole)
Pregnancy, breast-feeding or planned pregnancy during the study
A Child in Care (CiC) is a child who has been placed under the control or protection of an agency, organisation, institution or entity by the courts, the government or a government body, acting in accordance with powers conferred on them by law or regulation.
Clareo Health | SAS115359: A 6-month Study to Assess the Safety and Benefit of Inhaled Fluticasone Propionate/Salmeterol Combination Compared With Inhaled Fluticasone Propionate in the Treatment of Adolescents and Adults (12 Years of Age and Older) With Asthma.
