Study of Asthma and Nasal Steroids
STAN
3 other identifiers
interventional
388
1 country
19
Brief Summary
The trial will study the effectiveness of nasal steroids for the treatment of chronic rhinitis and/or sinusitis on asthma control.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4 asthma
Started Sep 2010
Longer than P75 for phase_4 asthma
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2010
CompletedFirst Posted
Study publicly available on registry
May 6, 2010
CompletedStudy Start
First participant enrolled
September 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedResults Posted
Study results publicly available
November 30, 2015
CompletedNovember 30, 2015
October 1, 2015
3.8 years
April 28, 2010
September 24, 2015
October 29, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Asthma Control Test (ACT)
Asthma Control Test for adults (score range: 5-25); higher score indicates better asthma control
24 weeks
Secondary Outcomes (1)
Childhood Asthma Control Test
24 weeks
Study Arms (2)
Nasal Steroid
ACTIVE COMPARATORIntranasal mometasone, 1 spray (age \< 12 yr) or 2 sprays (age \>= 12 yrs) each nostril once a day
Placebo
PLACEBO COMPARATORIntranasal placebo, 1 spray (age \< 12 yr) or 2 sprays (age \>= 12 yrs) each nostril once a day
Interventions
Intranasal mometasone, 1 spray (age \< 12 yr) or 2 sprays (age \>= 12 yrs) each nostril once a day for 6 months
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
University of Arizona
Tucson, Arizona, 85724, United States
University of California, San Diego
San Diego, California, 92103, United States
National Jewish Health
Denver, Colorado, 80206, United States
Nemours Children's Clinic
Jacksonville, Florida, 32207, United States
Univeristy of Miami School of Medicine
Miami, Florida, 33136, United States
University of South Florida College of Medicine
Tampa, Florida, 33613, United States
Northwestern Memorial Hospital
Chicago, Illinois, 60612, United States
Indiana University
Indianapolis, Indiana, 46202, United States
Louisiana State University Health Sciences Center
New Orleans, Louisiana, 70112, United States
University of Missouri, Kansas City School of Medicine
Kansas City, Missouri, 64108, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
North Shore-Long Island Jewish Health System
New Hyde Park, New York, 11040, United States
New York University School of Medicine
New York, New York, 10016, United States
New York Medical College
Valhalla, New York, 10595, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Davis Heart and Lung Research Institute
Columbus, Ohio, 43210, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Vermont Lung Center at the University of Vermont
Burlington, Vermont, 05405, United States
Univeristy of Virginia
Charlottesville, Virginia, 22908, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Razan Yasin
- Organization
- Johns Hopkins University
Study Officials
- PRINCIPAL INVESTIGATOR
Anne Dixon, MD
University of Vermont
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2010
First Posted
May 6, 2010
Study Start
September 1, 2010
Primary Completion
June 1, 2014
Study Completion
June 1, 2015
Last Updated
November 30, 2015
Results First Posted
November 30, 2015
Record last verified: 2015-10