Steroids In Eosinophil Negative Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Mometasone 220mcg BID; Tiotropium Respimat 5mcg QD; Placebo
Intervention description: Mometasone is an ICS; Tiotropium is a LMA
Intervention MeSH terms: Mometasone Furoate; Tiotropium Bromide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 295.0
Sex: All
Minimum age: 12 Years
Healthy volunteers: No
Keywords: Asthma; Mometasone; Tiotropium

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.
    

Eligibility criteria:

        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.