Study of Asthma and Nasal Steroids

Phase 4

Completed

Conditions: Sinusitis
Asthma
Rhinitis

Interventions: Drug: Mometasone Furoate monohydrate
Other: Placebo

Registration Number: NCT01118312

Lead Sponsor: JHSPH Center for Clinical Trials

Brief Summary: The trial will study the effectiveness of nasal steroids for the treatment of chronic rhinitis and/or sinusitis on asthma control.

Detailed Description: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 388

Inclusion Criteria

Physician diagnosed asthma
At least 12% increase in forced expiratory volume at one second (FEV1) after 2-4 puffs of albuterol or positive methacholine challenge (20% fall in FEV1 at less than 16 mg/ml methacholine); either of these can be available from the last 2 years before enrollment
Poorly controlled asthma as documented by a score of 19 or less on the Asthma Control Test (ACT) for participants 12 and older, and a Childhood Asthma Control Test (C-ACT) for 6-11 years(both V1 and V2).
Chronic symptoms of rhinitis and sinusitis as measured by a mean score of 1 on the Sino-nasal questionnaire
Males and females, age 6 and older

Exclusion Criteria

Co-morbidity that predisposes to complicated rhino-sinusitis (e.g., cystic fibrosis, insulin dependent diabetes mellitus, immunodeficiency disorder)
Chronic diseases (other than asthma) that in the opinion of the investigator would prevent participation in the trial or put the participant at risk by participation, e.g. chronic diseases of the lung (other than asthma), heart, liver, kidney or nervous system.
History of sinus surgery in last 6 months
Systemic/nasal steroids within last 4 weeks
Anti-leukotriene medication
History of upper airway symptoms for less than 8 weeks at the time of enrollment
Fever > 38.3 degrees Celsius or patient history of fever in last 10 days
Greater than 10 pack year smoking history or active smoking within the last 6 months
FEV1 < 50% predicted
Females of childbearing potential that are pregnant or lactating, or unwilling to practice an adequate birth control method
Allergy or intolerance to nasal mometasone
Cataracts, history of glaucoma, or other conditions resulting in increased intraocular pressure
Any investigational drug in the last 6 weeks
Inability to comply with study procedures, including:
- Inability or unwillingness to provide informed consent (or assent in the case of a minor)
- Inability to take study medication
- Inability to perform baseline measurements
- Completion of less than 10 of the 14 days of screening period diary entry
- Inability to be contacted by phone
- Intention to move out of the area within 6 months

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nasal Steroid	Mometasone Furoate monohydrate	Intranasal mometasone, 1 spray (age \< 12 yr) or 2 sprays (age \>= 12 yrs) each nostril once a day
Placebo	Placebo	Intranasal placebo, 1 spray (age \< 12 yr) or 2 sprays (age \>= 12 yrs) each nostril once a day

Primary Outcome Measures

Name	Time	Method
Asthma Control Test (ACT)	24 weeks	Asthma Control Test for adults (score range: 5-25); higher score indicates better asthma control

Secondary Outcome Measures

Name	Time	Method
Childhood Asthma Control Test	24 weeks	Childhood Asthma Control Test (score range: 0-27); higher score indicates better asthma control

Trial Locations

Locations (19): New York Medical College
🇺🇸
Valhalla, New York, United States
Baylor College of Medicine
🇺🇸
Houston, Texas, United States
National Jewish Health
🇺🇸
Denver, Colorado, United States
Univeristy of Miami School of Medicine
🇺🇸
Miami, Florida, United States
University of Arizona
🇺🇸
Tucson, Arizona, United States
Nemours Children's Clinic
🇺🇸
Jacksonville, Florida, United States
Vermont Lung Center at the University of Vermont
🇺🇸
Burlington, Vermont, United States
University of South Florida College of Medicine
🇺🇸
Tampa, Florida, United States
New York University School of Medicine
🇺🇸
New York, New York, United States
Davis Heart and Lung Research Institute
🇺🇸
Columbus, Ohio, United States
University of California, San Diego
🇺🇸
San Diego, California, United States
Univeristy of Virginia
🇺🇸
Charlottesville, Virginia, United States
North Shore-Long Island Jewish Health System
🇺🇸
New Hyde Park, New York, United States
Northwestern Memorial Hospital
🇺🇸
Chicago, Illinois, United States
University of Missouri, Kansas City School of Medicine
🇺🇸
Kansas City, Missouri, United States
Washington University School of Medicine
🇺🇸
St. Louis, Missouri, United States
Indiana University
🇺🇸
Indianapolis, Indiana, United States
Duke University Medical Center
🇺🇸
Durham, North Carolina, United States
Louisiana State University Health Sciences Center
🇺🇸
New Orleans, Louisiana, United States