Nasonex Compared With Placebo in Participants With Seasonal Allergic Rhinitis (SAR) and Concomitant Asthma (P03280)
Condition: Rhinitis, Allergic, Seasonal; Asthma
MeSH terms: Rhinitis; Asthma; Rhinitis, Allergic, Seasonal; Rhinitis, Allergic
Intervention: Mometasone; Placebo; Albuterol/Salbutamol
Intervention description: Mometasone nasal spray 200 mcg/day administered as 2 sprays (50 mcg/spray) in each nostril.; Matching placebo nasal spray, administered QD as 2 sprays in each nostril.; Albuterol/salbutamol metered dose inhaler (90 mcg/puff) used as needed as asthma rescue medication.
Intervention MeSH terms: Mometasone Furoate; Albuterol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 188.0
Sex: All
Minimum age: 15 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: Seasonal Allergic Rhinitis; Asthma

Summary:

      This study will compare mometasone nasal spray to placebo in treating the nasal and asthma
      symptoms experienced by participants with seasonal allergic rhinitis (SAR) and concomitant
      asthma.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have at least a two-year history of seasonal allergic rhinitis and an increase in
             asthma symptoms associated with the allergy season under study

          -  Demonstrate an increase in absolute FEV 1 less than 12%, with an absolute volume
             increase of at least 200 ml, after reversibility testing within the past 12 months

          -  Is skin test positive (skin prick test with a wheal diameter at least 3 mm larger than
             the diluent control or intradermal testing with the wheal diameter at least 7 mm
             larger than diluent control) at screening, or within 12 months prior to the screening
             visit, to a seasonal allergen (which may include seasonal molds) prevalent during the
             study period.

          -  Female participants of childbearing potential use a medically accepted method of birth
             control and agree to continue its use during the study or be surgically sterilized
             (eg, hysterectomy or tubal ligation). Females who are not sexually active at time of
             study agree and consent to use a medically acceptable method of birth control should
             they become sexually active while participating in the study.

        Exclusion Criteria:

          -  Female participants who are pregnant, intend to become pregnant during the duration of
             the study, or are nursing.

          -  Have asthma symptoms and require chronic use of inhaled or systemic corticosteroids.

          -  Have current or historical frequent (2 or more episodes per year for the past 2
             years), clinically significant sinusitis or chronic purulent postnasal drip.

          -  Have recent nasal septum ulcers, nasal surgery or nasal trauma, which should not be
             included until healing occurs.

          -  Have rhinitis medicamentosa or chronic obstructive pulmonary disease (COPD).

          -  Have an upper or lower respiratory tract or sinus infection that requires antibiotic
             therapy, or have a viral upper or lower respiratory infection.

          -  Have nasal structural abnormalities, including large nasal polyps and marked septum
             deviation, that significantly interferes with nasal air flow.

          -  Are dependent on nasal topical antihistamines, or nasal steroids.

          -  On immunotherapy (desensitization therapy) and will receive an increase in dose during
             the study; participants who will receive desensitization treatment within 24 hours
             prior to a study visit.

          -  Is a participant who smokes, or is an ex-smoker who has smoked within the previous six
             months.

          -  Is an investigator, study staff member, or family member involved with this study.

          -  Has active or quiescent tuberculosis infection of the respiratory tract, untreated
             fungal, bacterial, or systemic viral infections, or herpes simplex.

          -  Is a participant whose ability to provide informed consent is compromised.

          -  Has a history of non-compliance with medications or treatment protocols.

          -  Is morbidly obese (BMI >35).

          -  Is a night-shift worker or does not have a standard asleep at night/awake during the
             day cycle.

          -  Has any history of life-threatening asthma attacks or is treated in the emergency room
             or admitted to the hospital for asthma control within the previous 3 months or more
             than once in the previous 6 months