Asthma Treatment with Steroids: The SIENA Study – Phase III

Steroids in Eosinophil-Negative Asthma (SIENA)

Protocol Description

This AsthmaNet multi-center research study aims to determine if some patients benefit differently from inhaled corticosteroid treatment compared to others. Several types of cells can cause airway inflammation, yet inhaled corticosteroids mostly target eosinophil cells. In this study, the effect of a medium-dose of the inhaled corticosteroid mometasone (known by the trade name Asmanex®) will be compared with the effect of the muscarinic antagonist tiotropium bromide (known by the trade name Spiriva®), and the effects when only a placebo is used.

Study Level: Phase III

Eligibility Criteria

Subject to certain exclusion criteria, the study is accepting patients of both genders, ages 12 and older, who have asthma.
Males and Females: Ages 12 years and older


Participants who join this study will be included in the AsthmaNet Registry. Following initial screening, the first stage of the study is a 4 to 6 week “run-in” period, in which participants will have 3 study visits for exams and testing. Those who are eligible to continue in the study will have 6 additional study visits for exams and testing over the next 36 weeks. During this period, they will use a provided inhaler each morning and evening, using an assigned study drug or the placebo for 12-week intervals. Participants or their parent/guardians will maintain diaries to track asthma control over the course of the study.
Visits: 9 plus telephone follow up with research team
Duration: 42 weeks

Status: Open to Enrollment

Source(s) of Support

National Heart, Lung, and Blood Institute, National Institutes of Health

Primary Investigator

Fernando Holguin, MD

Contact Information

For more information about the study or enrollment, please contact:
Rose Lanzo, Research Coordinator