Clinical trial NCT01118312: Study of Asthma and Nasal Steroids
Official title: Study of Asthma and Nasal Steroids for the American Lung Association-Airways Clinical Research Centers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Rhinitis
Sinusitis
Keywords: Asthma
Rhinitis
Sinusitis
Chronic
ACRC
STAN
Nasal steroid
Mometasone
Nasal spray
Lead sponsor: JHSPH Center for Clinical Trials
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2010-05-06
Enrollment: 388
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Asthma Control Test (ACT)
timeFrame: 24 weeks
Secondary outcomes:
measure: Childhood Asthma Control Test
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: San Diego
country: United States
facility: University of California, San Diego
state: California
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Jacksonville
country: United States
facility: Nemours Children's Clinic
state: Florida
city: Miami
country: United States
facility: Univeristy of Miami School of Medicine
state: Florida
city: Tampa
country: United States
facility: University of South Florida College of Medicine
state: Florida
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: New Orleans
country: United States
facility: Louisiana State University Health Sciences Center
state: Louisiana
city: Kansas City
country: United States
facility: University of Missouri, Kansas City School of Medicine
state: Missouri
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: New Hyde Park
country: United States
facility: North Shore-Long Island Jewish Health System
state: New York
city: New York
country: United States
facility: New York University School of Medicine
state: New York
city: Valhalla
country: United States
facility: New York Medical College
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Columbus
country: United States
facility: Davis Heart and Lung Research Institute
state: Ohio
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Burlington
country: United States
facility: Vermont Lung Center at the University of Vermont
state: Vermont
city: Charlottesville
country: United States
facility: Univeristy of Virginia
state: Virginia
Study officials:
affiliation: University of Vermont
name: Anne Dixon, MD
role: PRINCIPAL_INVESTIGATOR
References: