Steroids In Eosinophil Negative Asthma (SIENA)

Penn State Health

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Tiotropium Respimat 5mcg QD; Drug: Placebo; Drug: Mometasone 220mcg BID

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02066298

1U10HL098115 (U.S. NIH Grant/Contract)

AsthmaNet 007

Details and patient eligibility

About

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.

Full 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).

Enrollment: 295 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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295 participants in 6 patient groups

Mometasone then Tiotropium then Placebo

Experimental group

Description:

Mometasone 220mcg BID, followed by Tiotropium Respimat 5mcg QD, followed by Placebo

Treatment:

Drug: Mometasone 220mcg BID

Drug: Tiotropium Respimat 5mcg QD

Drug: Placebo

Mometasone then Placebo then Tiotropium

Experimental group

Description:

Mometasone 220mcg BID, followed by Placebo, followed by Tiotropium Respimat 5mcg QD

Treatment:

Drug: Mometasone 220mcg BID

Drug: Tiotropium Respimat 5mcg QD

Drug: Placebo

Placebo then Mometasone then Tiotropium

Experimental group

Description:

Placebo, followed by Mometasone 220mcg BID, followed by Tiotropium Respimat 5mcg QD

Treatment:

Drug: Mometasone 220mcg BID

Drug: Tiotropium Respimat 5mcg QD

Drug: Placebo

Placebo then Tiotropium then Mometasone

Experimental group

Description:

Placebo, followed by Tiotropium Respimat 5mcg QD, followed by Mometasone 220mcg BID

Treatment:

Drug: Mometasone 220mcg BID

Drug: Tiotropium Respimat 5mcg QD

Drug: Placebo

Tiotropium then Placebo then Mometasone

Experimental group

Description:

Tiotropium Respimat 5mcg QD, followed by Placebo, followed by Mometasone 220mcg BID

Treatment:

Drug: Mometasone 220mcg BID

Drug: Tiotropium Respimat 5mcg QD

Drug: Placebo

Tiotropium then Mometasone then Placebo

Experimental group

Description:

Tiotropium Respimat 5mcg QD, followed by Mometasone 220mcg BID, followed by Placebo

Treatment:

Drug: Mometasone 220mcg BID

Drug: Tiotropium Respimat 5mcg QD

Drug: Placebo