Study of Asthma and Nasal Steroids (STAN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01118312
Recruitment Status : Completed
First Posted : May 6, 2010
Results First Posted : November 30, 2015
Last Update Posted : November 30, 2015
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Asthma Rhinitis Sinusitis Drug: Mometasone Furoate monohydrate Other: Placebo Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 388 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Study of Asthma and Nasal Steroids for the American Lung Association-Airways Clinical Research Centers
Study Start Date : September 2010
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Sinusitis

Arm Intervention/treatment
Active Comparator: Nasal Steroid
Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day
Drug: Mometasone Furoate monohydrate
Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day for 6 months
Other Name: Nasonex

Placebo Comparator: Placebo
Intranasal placebo, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day
Other: Placebo
Intranasal placebo spray

Primary Outcome Measures :
  1. Asthma Control Test (ACT) [ Time Frame: 24 weeks ]
    Asthma Control Test for adults (score range: 5-25); higher score indicates better asthma control

Secondary Outcome Measures :
  1. Childhood Asthma Control Test [ Time Frame: 24 weeks ]
    Childhood Asthma Control Test (score range: 0-27); higher score indicates better asthma control

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01118312

United States, Arizona
University of Arizona
Tucson, Arizona, United States, 85724
United States, California
University of California, San Diego
San Diego, California, United States, 92103
United States, Colorado
National Jewish Health
Denver, Colorado, United States, 80206
United States, Florida
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
Univeristy of Miami School of Medicine
Miami, Florida, United States, 33136
University of South Florida College of Medicine
Tampa, Florida, United States, 33613
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60612
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Louisiana
Louisiana State University Health Sciences Center
New Orleans, Louisiana, United States, 70112
United States, Missouri
University of Missouri, Kansas City School of Medicine
Kansas City, Missouri, United States, 64108
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, New York
North Shore-Long Island Jewish Health System
New Hyde Park, New York, United States, 11040
New York University School of Medicine
New York, New York, United States, 10016
New York Medical College
Valhalla, New York, United States, 10595
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
Davis Heart and Lung Research Institute
Columbus, Ohio, United States, 43210
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Vermont
Vermont Lung Center at the University of Vermont
Burlington, Vermont, United States, 05405
United States, Virginia
Univeristy of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
JHSPH Center for Clinical Trials
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Anne Dixon, MD University of Vermont

Additional Information:
Responsible Party: JHSPH Center for Clinical Trials Identifier: NCT01118312     History of Changes
Other Study ID Numbers: ALAACRC-11
R01 HL089464-01A2 ( Other Identifier: NIH/NHLBI )
R01 HL00895101-01A2 ( Other Identifier: NIH/NHLBI )
First Posted: May 6, 2010    Key Record Dates
Results First Posted: November 30, 2015
Last Update Posted: November 30, 2015
Last Verified: October 2015

Keywords provided by JHSPH Center for Clinical Trials:
Nasal steroid
Nasal spray

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Paranasal Sinus Diseases
Mometasone Furoate
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents