Steroids In Eosinophil Negative Asthma

  • Interventional
  • Recruiting
  • NCT02066298
Eligibility Details Visit Clinicaltrials.gov

Steroids In Eosinophil Negative Asthma

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.

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).

Gender
All

Age Group
12 Years and up

Accepting Healthy Volunteers?
No

Inclusion Criteria:

         - Physician-diagnosed asthma for at least previous 12 months.

         - Able to perform reproducible spirometry.

         - Baseline FEV1≥70% of predicted.

         - Asthma confirmed either by:

             - Beta-agonist reversibility to 4 puffs albuterol ≥ 12% OR

             - Methacholine PC20 ≤ 16 mg/ml

         - At least 1 of the following indications for chronic controller therapy:

             - Asthma Symptoms > 2 days/week OR

             - Nocturnal Asthma Symptoms > 2 nights/month OR

             - Short-acting beta-agonist use for symptom control > 2 days/week

         - For participants ≥18 years of age: Ability to provide informed consent. For participants under 18 years of age: Ability to provide verbal or written assent and ability of parent to provide informed consent.

         - Willingness, if female and able to conceive, to utilize one medically-acceptable form of contraception.

        Exclusion Criteria:

         - Chronic inhaled or oral corticosteroid therapy.

         - Use of inhaled or oral corticosteroid therapy within 6 weeks.

         - New allergen immunotherapy within the past 3 months or anticipated changes to an ongoing immunotherapy regimen.

         - Use of omalizumab within 3 months.

         - History of:

             - bladder-neck obstruction, urinary retention or benign prostatic hyperplasia

             - narrow angle glaucoma

             - significant cardiovascular disorders and arrhythmias

             - life-threatening asthma requiring treatment with intubation or mechanical ventilation within the past 5 years

         - Respiratory tract infection within past 6 weeks.

         - History of smoking within the past 1 year, or > 10 pack-years total if ≥ 18 years of age, or > 5 pack-years total if < 18 years of age.

         - Chronic diseases or medical conditions (other than asthma) that could put the participant at risk by participation, e.g. chronic diseases of the lung (other than asthma), heart, liver, kidney, endocrine or nervous system, or immunodeficiency.

At a Glance

National Government IDNCT02066298

IRB#IRB14-0445

Lead SponsorMilton S. Hershey Medical Center

Lead PhysicianEdward Naureckas

Collaborator(s)N/A

EligibilityAll
12 Years and up
Recruiting