An Exploratory Study of Nasonex in Patients With Moderate to Severe Persistent Allergic Rhinitis and Intermittent Asthma

Inclusion Criteria:

• Outpatients (≥18 and ≤ 75 years of age) of either sex

• Willingness to participate and comply with procedures by signing a written informedconsent

• Moderate/severe persistent allergic rhinitis with a history of intermittent asthmafrom at least 2 years and actual asthma (symptoms in the last 4 weeks)

• To qualify at the randomization visit the daily average of the T5SS [(Morning-timeT5SS + Evening-time T5SS)/2] had to be ≥ 6 in at least 4 days during the 1 weekrun-in period

• Positive (weal diameter >3 mm) skin prick test (SPT) and/or CAP-RAST (class II orhigher) performed in the 6 months prior to the start of the trial were required forat least house dust mite and 1 pollen allergen (grass or Parietaria, IgE level >3.5U/mL)

• All prior medication washout times had been observed

• Female volunteers of childbearing potential had to agree to use a medically acceptedmethod of contraception or be surgically sterilized prior to screening, whilereceiving protocol-specified medication, and for 30 days after stopping themedication

• Negative urine pregnancy test

• Free of any clinically relevant disease that would have interfered with studyevaluations

• Able to adhere to the dosing and visit schedules, and agree to record symptomseverity scores and use of IMP and rescue medications in a daily diary

Exclusion Criteria:

• Female who was or intended to become pregnant during the study or within 12 weeksafter study completion

• Nursing, or intended to be nursing during the study or within 12 months after studycompletion

• Taking medications prohibited during the study or had not complied with therequirements for the designated washout periods for any of the prohibitedmedications

• Anatomical abnormalities of the nose (turbinate hypertrophy, septal deviation,polyps)

• Acute or chronic sinusitis currently being treated with antibiotics and/or topicalor oral decongestants

• Rhinitis medicamentosa

• Evidence of persistent asthma, or asthma with daytime and nighttime symptoms notcontrolled by short-acting beta2-adrenoceptor agonists

• Asthma requiring chronic use of inhaled or systemic corticosteroids

• Upper respiratory tract or sinus infection that required antibiotic therapy and hadnot had at least a 14-day wash-out period prior to the run-in period, or had a viralupper respiratory infection within 7 days prior to screening

• Dependence on nasal, oral or ocular decongestants, nasal topical antihistamines, ornasal steroids

• Undergoing a progressive course of immunotherapy (hyposensitization). Subjects on aregular maintenance schedule prior to the screening visit were eligible for studyinclusion; however, subject could not receive hyposensitization treatment within 24hours prior to any study visit

• Diagnosed of cancer within the past 5 years (except for successfully treated basaland squamous cell carcinomas)

• Concomitant medical problem

• Had any of the following clinical conditions: active or quiescent tuberculosisinfection of the respiratory tract, untreated fungal, bacterial, systemic viralinfections or ocular herpes simplex

• Smoked or had smoked within the previous 6 months

• Member of the staff, affiliated with, or family member of the staff personneldirectly involved with this study

• Previously randomized into this study

• Any other clinically significant deviation from normal in the physical examinationor medical history that could interfere with the study evaluation or affect subjectsafety

• In a situation or condition that could interfere with participation in the study

• Used any drug or device in an investigational protocol in the 30 days prior to visit 1

• Participating in other clinical studies

• Allergic or has sensitivity to the study drug or its excipients

• Compromised ability to provide informed consent

• History of non-compliance with medication or treatment protocols