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Study of Asthma and Nasal Steroids | Clinical Trials | Clareo Health

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Study of Asthma and Nasal Steroids

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

NCT01118312•JHSPH Center for Clinical Trials

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.

Eligibility

Age

6 - No limit years

Sex

ALL

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
+10 more criteria

Locations (19)

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

Key Dates

Start Date

September 1, 2010

Primary Completion Date

June 1, 2014

Completion Date

June 1, 2015

Last Updated

November 30, 2015

Enrollment

388

ACTUAL participants

Conditions

AsthmaRhinitisSinusitis

Interventions

Mometasone Furoate monohydrate

DRUG

Placebo

OTHER

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

NCT07486401

Asthma ExacerbationsBiomarkers / Blood+1 more

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RECRUITING

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

NCT02327897

Asthma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 30, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study of Asthma and Nasal Steroids

Inclusion Criteria

Exclusion Criteria

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

Relationship of Airway Microbiota, Endotype and Phenotype in Adult Asthma

To Assess the Management of Patients on Global Initiative of Asthma (GINA) Step 4 and 5 Treatment in Hong Kong

A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma