Study of Asthma and Nasal Steroids
Condition: Asthma; Rhinitis; Sinusitis
MeSH terms: Rhinitis; Sinusitis; Asthma
Intervention: Mometasone Furoate monohydrate; Placebo
Intervention description: Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day for 6 months; Intranasal placebo spray
Intervention MeSH terms: Mometasone Furoate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Enrollment: 388.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No
Keywords: Asthma; Rhinitis; Sinusitis; Chronic; ACRC; STAN; Nasal steroid; Mometasone; Nasal spray

Summary:

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

Eligibility criteria:

        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