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Study of Asthma and Nasal Steroids (STAN)

Primary Purpose

Asthma, Rhinitis, Sinusitis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Mometasone Furoate monohydrate
Placebo
Sponsored by
JHSPH Center for Clinical Trials
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Rhinitis, Sinusitis, Chronic, ACRC, STAN, Nasal steroid, Mometasone, Nasal spray

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Arizona
  • University of California, San Diego
  • National Jewish Health
  • Nemours Children's Clinic
  • Univeristy of Miami School of Medicine
  • University of South Florida College of Medicine
  • Northwestern Memorial Hospital
  • Indiana University
  • Louisiana State University Health Sciences Center
  • University of Missouri, Kansas City School of Medicine
  • Washington University School of Medicine
  • North Shore-Long Island Jewish Health System
  • New York University School of Medicine
  • New York Medical College
  • Duke University Medical Center
  • Davis Heart and Lung Research Institute
  • Baylor College of Medicine
  • Vermont Lung Center at the University of Vermont
  • Univeristy of Virginia

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Nasal Steroid

Placebo

Arm Description

Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Childhood Asthma Control Test
Childhood Asthma Control Test (score range: 0-27); higher score indicates better asthma control

Full Information

First Posted
April 28, 2010
Last Updated
October 29, 2015
Sponsor
JHSPH Center for Clinical Trials
Collaborators
National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT01118312
Brief Title
Study of Asthma and Nasal Steroids
Acronym
STAN
Official Title
Study of Asthma and Nasal Steroids for the American Lung Association-Airways Clinical Research Centers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
JHSPH Center for Clinical Trials
Collaborators
National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Rhinitis, Sinusitis
Keywords
Asthma, Rhinitis, Sinusitis, Chronic, ACRC, STAN, Nasal steroid, Mometasone, Nasal spray

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
388 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nasal Steroid
Arm Type
Active Comparator
Arm Description
Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Intranasal placebo, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day
Intervention Type
Drug
Intervention Name(s)
Mometasone Furoate monohydrate
Other Intervention Name(s)
Nasonex
Intervention Description
Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day for 6 months
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Intranasal placebo spray
Primary Outcome Measure Information:
Title
Asthma Control Test (ACT)
Description
Asthma Control Test for adults (score range: 5-25); higher score indicates better asthma control
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Childhood Asthma Control Test
Description
Childhood Asthma Control Test (score range: 0-27); higher score indicates better asthma control
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Dixon, MD
Organizational Affiliation
University of Vermont
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
University of California, San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
Nemours Children's Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Univeristy of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University of South Florida College of Medicine
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Northwestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Louisiana State University Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
University of Missouri, Kansas City School of Medicine
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
North Shore-Long Island Jewish Health System
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Davis Heart and Lung Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Vermont Lung Center at the University of Vermont
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States
Facility Name
Univeristy of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.cctrials.org/alaacrc
Description
ALA-ACRC Webpage

Learn more about this trial

Study of Asthma and Nasal Steroids

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