Step-up Yellow Zone Inhaled Corticosteroids to Prevent Exacerbations



Status:Completed
Conditions:Asthma
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:5 - 11
Updated:7/13/2018
Start Date:July 2014
End Date:April 21, 2017

Use our guide to learn which trials are right for you!

The objective of this study is to determine whether, in children receiving low-dose inhaled
corticosteroids (ICS), quintupling the dose of inhaled corticosteroids at the onset of
symptoms previously associated with upper respiratory illnesses and subsequent asthma
exacerbations reduces the rate of severe asthma exacerbations treated with oral
corticosteroids.

The study design is a double-blind, parallel-group trial, including a total of 250
participants, ages 5-11 years, with a diagnosis of asthma and a history of at least 1 asthma
exacerbation treated with oral corticosteroids in the prior year. All participants will be
treated for 48 weeks with open-label fluticasone 44 mcg 2 puffs twice daily. During the
48-week treatment period, participants will receive randomized blinded therapy for 7 days
each time they enter the "yellow zone" (at the onset of symptoms previously associated with
upper respiratory illnesses and subsequent asthma exacerbations). Yellow zone therapy will be
fluticasone 44 or 220 mcg 2 puffs twice daily.

Inclusion Criteria:

- Physician-diagnosed asthma

- At least 1 exacerbation treated with systemic (oral or injectable) corticosteroids in
the past 12 months

- Able to perform reproducible spirometry

- Current treatment with step 2 controller therapy [low-dose ICS, leukotriene receptor
antagonist (LTRA)] OR current treatment with step 3 controller therapy [low-dose ICS +
long-acting beta agonist (LABA), low-dose ICS + LTRA, or medium dose ICS] with a
childhood Asthma Control Test (c-ACT) score of >19, no more than 2 prednisone treated
exacerbations in the past 6 months, prebronchodilator Forced Expiratory Volume at 1
second (FEV1) ≥ 80% predicted and willing to step down therapy OR controller naïve and
qualifying for step 2 controller therapy [asthma symptoms or short acting beta agonist
(SABA) use > 2 days per week or night-time awakenings due to asthma > 2 nights per
month]

- Prebronchodilator FEV1 ≥ 60% predicted

- Ability and willingness to provide informed assent

- For females of childbearing potential: not pregnant, non-lactating, and agree to
practice an adequate birth control method.

- History of clinical varicella or varicella vaccine

Exclusion Criteria:

- Systemic (oral or injectable) corticosteroids within previous 2-week period

- Current or recent (previous 2-weeks) use of medications known to significantly
interact with corticosteroid disposition, including but not limited to carbamazepine,
erythromycin, phenobarbital, phenytoin, rifampin, and ketoconazole

- Presence of chronic or active lung disease other than asthma

- Significant medical illness other than asthma, including thyroid disease, diabetes
mellitus, Cushing's disease, Addison's disease, hepatic disease, or concurrent medical
problems that could require oral corticosteroids during the study

- A history of cataracts, glaucoma, or any other medical disorder associated with an
adverse effect to corticosteroids

- History of a life-threatening asthma exacerbation requiring intubation, mechanical
ventilation, or resulting in a hypoxic seizure

- More than 5 prednisone treated exacerbations in the past 12 months

- More than 1 hospitalizations lasting >24 hours for asthma in the past 12 months

- History of adverse reactions to ICS preparations or any of their ingredients

- Receiving hyposensitization therapy other than an established maintenance regimen (On
maintenance regimen for ≥ 3 months)

- History of premature birth before 35 weeks gestation
We found this trial at
18
sites
Madison, Wisconsin 53792
(608) 263-2400
University of Wisconsin In achievement and prestige, the University of Wisconsin–Madison has long been recognized...
?
mi
from
Madison, WI
Click here to add this to my saved trials
201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
807 Childrens Way
Jacksonville, Florida 32207
(904) 697-3600
Nemours Children's Clinic At Nemours Children’s Clinic, Jacksonville, we've treated every child as we would...
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
747 52nd St
Oakland, California 94609
(510) 428-3000
Children's Hospital and Research Center Oakland For nearly 100 years, Children's Hospital & Research Center...
?
mi
from
Oakland, CA
Click here to add this to my saved trials
4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
412-692-5325
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Boston, Massachusetts 02115
?
mi
from
Boston, MA
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Chicago, IL
Click here to add this to my saved trials
2035 W Taylor St
Chicago, Illinois
(312) 996-4350
University of Illinois at Chicago A major research university in the heart of one of...
?
mi
from
Chicago, IL
Click here to add this to my saved trials
1400 Jackson St
Denver, Colorado 80206
(303) 388-4461
National Jewish Health National Jewish Health is known worldwide for treatment of patients with respiratory,...
?
mi
from
Denver, CO
Click here to add this to my saved trials
Orlando, Florida 32806
?
mi
from
Orlando, FL
Click here to add this to my saved trials
320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Saint Louis, Missouri 63110
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Saint Louis, Missouri 63110
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
San Francisco, California 94143
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials