The trial will study the effectiveness of nasal steroids for the treatment of chronic rhinitis and/or sinusitis on asthma control.
Previous trials completed by the American Lung Association-Airways Clinical Research Centers (ALA-ACRC) network have identified rhinitis and/or sinusitis as a significant co-morbidity in people with asthma that affects asthma symptoms and control. The objective of this clinical trial is to determine if treatment of chronic rhinitis and/or sinusitis with nasal steroids improves control of asthma in children and adults. Although chronic rhinitis and/or sinusitis have been associated with poor asthma control and increased health care utilization, the effect of treating these diseases on asthma control is not known. This will be a six-month randomized, double-blinded, placebo-controlled trial enrolling 380 participants, 190 children and 190 adults, with poorly controlled asthma and chronic rhinitis/sinusitis. Participants will be randomized to receive nasal steroid or a matching placebo in addition to their regular asthma treatments. The primary objective of the trial will be to evaluate whether the addition of treatment with nasal steroids improves asthma control. We will perform allergy skin testing on all participants and keep a record of pollen counts at all centers, to determine if allergy is an important factor in the response to nasal steroid in participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
388
Intranasal mometasone, 1 spray (age \< 12 yr) or 2 sprays (age \>= 12 yrs) each nostril once a day for 6 months
Intranasal placebo spray
University of Arizona
Tucson, Arizona, United States
University of California, San Diego
Asthma Control Test (ACT)
Asthma Control Test for adults (score range: 5-25); higher score indicates better asthma control
Time frame: 24 weeks
Childhood Asthma Control Test
Childhood Asthma Control Test (score range: 0-27); higher score indicates better asthma control
Time frame: 24 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
San Diego, California, United States
National Jewish Health
Denver, Colorado, United States
Nemours Children's Clinic
Jacksonville, Florida, United States
Univeristy of Miami School of Medicine
Miami, Florida, United States
University of South Florida College of Medicine
Tampa, Florida, United States
Northwestern Memorial Hospital
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
Louisiana State University Health Sciences Center
New Orleans, Louisiana, United States
University of Missouri, Kansas City School of Medicine
Kansas City, Missouri, United States
...and 9 more locations