Study of Asthma and Nasal Steroids

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

Detailed Description
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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.

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

Conditions
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Asthma, Rhinitis, Sinusitis

Intervention / Treatment
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* Drug: Mometasone Furoate monohydrate
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Nasal Steroid<br>Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day | Drug: Mometasone Furoate monohydrate<br>* Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day for 6 months<br>* Other names: Nasonex;|
| Placebo Comparator: Placebo<br>Intranasal placebo, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day | Other: Placebo<br>* Intranasal placebo spray<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Rhinitis, Sinusitis, Chronic, ACRC, STAN, Nasal steroid, Mometasone, Nasal spray