Steroids In Eosinophil Negative Asthma

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

295 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2018-05-31

Brief Summary

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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.

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Detailed Description

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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

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Mometasone then Tiotropium then Placebo

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

Group Type EXPERIMENTAL

Mometasone 220mcg BID

Intervention Type DRUG

Mometasone is an ICS

Tiotropium Respimat 5mcg QD

Intervention Type DRUG

Tiotropium is a LMA

Placebo

Intervention Type DRUG

Mometasone then Placebo then Tiotropium

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

Group Type EXPERIMENTAL

Mometasone 220mcg BID

Intervention Type DRUG

Mometasone is an ICS

Tiotropium Respimat 5mcg QD

Intervention Type DRUG

Tiotropium is a LMA

Placebo

Intervention Type DRUG

Placebo then Mometasone then Tiotropium

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

Group Type EXPERIMENTAL

Mometasone 220mcg BID

Intervention Type DRUG

Mometasone is an ICS

Tiotropium Respimat 5mcg QD

Intervention Type DRUG

Tiotropium is a LMA

Placebo

Intervention Type DRUG

Placebo then Tiotropium then Mometasone

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

Group Type EXPERIMENTAL

Mometasone 220mcg BID

Intervention Type DRUG

Mometasone is an ICS

Tiotropium Respimat 5mcg QD

Intervention Type DRUG

Tiotropium is a LMA

Placebo

Intervention Type DRUG

Tiotropium then Placebo then Mometasone

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

Group Type EXPERIMENTAL

Mometasone 220mcg BID

Intervention Type DRUG

Mometasone is an ICS

Tiotropium Respimat 5mcg QD

Intervention Type DRUG

Tiotropium is a LMA

Placebo

Intervention Type DRUG

Tiotropium then Mometasone then Placebo

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

Group Type EXPERIMENTAL

Mometasone 220mcg BID

Intervention Type DRUG

Mometasone is an ICS

Tiotropium Respimat 5mcg QD

Intervention Type DRUG

Tiotropium is a LMA

Placebo

Intervention Type DRUG

Interventions

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Mometasone 220mcg BID

Mometasone is an ICS

Intervention Type DRUG

Tiotropium Respimat 5mcg QD

Tiotropium is a LMA

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Asmanex

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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dave mauger

Principal Investigator, AsthmaNet Data Coordinating Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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William Busse, M.D.

Role: STUDY_CHAIR

University of Wisconsin, Madison

Locations

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University of Arizona College of Medicine

Tucson, Arizona, United States

Site Status

UCSF Benioff Children's Hospital

San Francisco, California, United States

Site Status

University of California at San Francisco

San Francisco, California, United States

Site Status

National Jewish Health

Denver, Colorado, United States

Site Status

Nemours Children's Clinic

Jacksonville, Florida, United States

Site Status

Nemours Children's Clinic

Orlando, Florida, United States

Site Status