Study of Asthma and Nasal Steroids (STAN)

• Episodes of Poor Asthma Control (EPAC) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
• Methacholine challenge testing [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  Measures bronchial hyper-reactivity
• Sinusitis and rhinitis symptom scores [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  Measured using the Sinus Symptom Score questionnaire.
• Sinusitis and rhinitis quality of life [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  The Sinonasal Outcome Test (SNOT-22) and the Sinus and Nasal Quality of Life Survey (SN-5) questionnaires
• Daily diary cards [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  Diary cards provide accounts of: nocturnal asthma awakenings, asthma treatments, nasal and sinus symptoms, health care use (we will also record medications for sinus disease on these cards) and if a patient thinks they are currently in their allergy season.
• The Asthma Symptom Utility Index (ASUI) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
• Asthma specific quality of life measures [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

  Marks Asthma Quality of Life Questionnaire (Marks AQLQ)for participants 15 and older.

  The Children's Health Survey for Asthma (CHSA) for participants 6-15 years.

• Pulmonary function as measured by FEV1 and forced vital capacity (FVC) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
• Generic health-related quality of life [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

  The Medical Outcomes Study SF-36 (MOS-36)will be administered to participants 18 and older.

  Child Health Questionnaire (CHQ-PF50)will be administered to participants 6 - 17 years.

• Interval History / Health Care usage [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
• Rhinitis/Sinusitis Exacerbations [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Use of additional medication for upper airway symptoms
  • Health Care visit for upper airway symptoms
  • Patient self-report of episode of acute sinusitis or upper respiratory tract infection
• Serum and nasal lavage specimens [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  Collected to evaluate eotaxins and eosinophilic cationic protein (ecp).
• Exhaled nitric oxide (eNO) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
• asthma symptoms and menstruation (Asthma in Females Questionnaire) [ Time Frame: 0 weeks ] [ Designated as safety issue: No ]
• Smoke exposure (Smoke Exposure in Children questionnaire) [ Time Frame: 0 weeks ] [ Designated as safety issue: No ]
• Asthma severity and triggers [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
• Allergy skin testing [ Time Frame: 0 weeks ] [ Designated as safety issue: No ]

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

Previous trials completed by the 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.

• Asthma
• Rhinitis
• Sinusitis

• Drug: Mometasone Furoate monohydrate
  Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day for 6 months
  Other Name: Nasonex
• Other: Placebo
  Intranasal placebo spray

• Active Comparator: Nasal Steroid
  Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day
  Intervention: Drug: Mometasone Furoate monohydrate
• Placebo Comparator: Placebo
  Intranasal placebo, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day
  Intervention: Other: Placebo

Inclusion Criteria:

• Physician diagnosed asthma
• At least 12% increase in 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 > 38.3C 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

• National Institutes of Health (NIH)
• National Heart, Lung, and Blood Institute (NHLBI)