Study of Asthma and Nasal Steroids (STAN)

October 29, 2015 updated by: JHSPH Center for Clinical Trials

Study of Asthma and Nasal Steroids for the American Lung Association-Airways Clinical Research Centers

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

388

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Asthma Control Test (ACT)
Time Frame: 24 weeks
Asthma Control Test for adults (score range: 5-25); higher score indicates better asthma control
24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Childhood Asthma Control Test
Time Frame: 24 weeks
Childhood Asthma Control Test (score range: 0-27); higher score indicates better asthma control
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

JHSPH Center for Clinical Trials

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Anne Dixon, MD, University of Vermont

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

April 28, 2010

First Submitted That Met QC Criteria

May 5, 2010

First Posted (Estimate)

May 6, 2010

Study Record Updates

Last Update Posted (Estimate)

November 30, 2015

Last Update Submitted That Met QC Criteria

October 29, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ALAACRC-11
  • R01 HL089464-01A2 (Other Identifier: NIH/NHLBI)
  • R01 HL00895101-01A2 (Other Identifier: NIH/NHLBI)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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