Study of Asthma and Nasal Steroids

Completed · Phase 4 · Has a placebo group

Conditions studied: Asthma, Rhinitis, Sinusitis

In brief

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

Key facts

Study ID

NCT01118312

Run by

JHSPH Center for Clinical Trials

People needed

388

Starts

2010-09-01

Expected to finish

2015-06-01

Last updated by the study team

2015-11-30

Who can join

Age: 6 and older. Sex: any. Healthy volunteers: not accepted.

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)
• 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

Where it is running

• University of Arizona — Tucson, Arizona, United States
• University of California, San Diego — San Diego, California, United States
• National Jewish Health — Denver, Colorado, United States
• Nemours Children's Clinic — Jacksonville, Florida, United States
• Univeristy of Miami School of Medicine — Miami, Florida, United States
• University of South Florida College of Medicine — Tampa, Florida, United States
• Northwestern Memorial Hospital — Chicago, Illinois, United States
• Indiana University — Indianapolis, Indiana, United States
• Louisiana State University Health Sciences Center — New Orleans, Louisiana, United States
• University of Missouri, Kansas City School of Medicine — Kansas City, Missouri, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• North Shore-Long Island Jewish Health System — New Hyde Park, New York, United States
• New York University School of Medicine — New York, New York, United States
• New York Medical College — Valhalla, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Davis Heart and Lung Research Institute — Columbus, Ohio, United States
• Baylor College of Medicine — Houston, Texas, United States
• Vermont Lung Center at the University of Vermont — Burlington, Vermont, United States
• Univeristy of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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