Trials / Completed
CompletedNCT02066298
Steroids In Eosinophil Negative Asthma
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 295 (actual)
- Sponsor
- Milton S. Hershey Medical Center · Academic / Other
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
Because approximately half of all mild-moderately-severe asthma is persistently non-eosinophilic, it is important to determine prospectively if patients who are persistently non-eosinophilic differ in their benefit from inhaled corticosteroid treatment compared to patients who are not persistently non-eosinophilic.
Detailed description
SIENA is a 42-week randomized, stratified, 3-period double-blind placebo-controlled crossover study of patients with symptomatic mild-to-moderate asthma, not already taking an inhaled corticosteroid, in whom the effect of "medium-dose" inhaled corticosteroid (ICS) will be compared with the effect of placebo and with a long-acting muscarinic antagonist (LMA).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Mometasone 220mcg BID | Mometasone is an ICS |
| DRUG | Tiotropium Respimat 5mcg QD | Tiotropium is a LMA |
| DRUG | Placebo |
Timeline
- Start date
- 2014-07-01
- Primary completion
- 2018-05-01
- Completion
- 2018-05-01
- First posted
- 2014-02-19
- Last updated
- 2019-05-29
- Results posted
- 2019-04-18
Locations
25 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02066298. Inclusion in this directory is not an endorsement.