Study of Asthma and Nasal Steroids

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.

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