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

This is an interventional treatment trial for Allergic Rhinitis Read More

Inclusion Criteria:

• Outpatients (≥18 and ≤ 75 years of age) of either sex
• Willingness to participate and comply with procedures by signing a written informed consent
• Moderate/severe persistent allergic rhinitis with a history of intermittent asthma from 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-time T5SS + Evening-time T5SS)/2] had to be ≥ 6 in at least 4 days during the 1 week run-in period
• Positive (weal diameter >3 mm) skin prick test (SPT) and/or CAP-RAST (class II or higher) performed in the 6 months prior to the start of the trial were required for at least house dust mite and 1 pollen allergen (grass or Parietaria, IgE level >3.5 U/mL)
• All prior medication washout times had been observed
• Female volunteers of childbearing potential had to agree to use a medically accepted method of contraception or be surgically sterilized prior to screening, while receiving protocol-specified medication, and for 30 days after stopping the medication
• Negative urine pregnancy test
• Free of any clinically relevant disease that would have interfered with study evaluations
• Able to adhere to the dosing and visit schedules, and agree to record symptom severity 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 weeks after study completion
• Nursing, or intended to be nursing during the study or within 12 months after study completion
• Taking medications prohibited during the study or had not complied with the requirements for the designated washout periods for any of the prohibited medications
• Anatomical abnormalities of the nose (turbinate hypertrophy, septal deviation, polyps)
• Acute or chronic sinusitis currently being treated with antibiotics and/or topical or oral decongestants
• Rhinitis medicamentosa
• Evidence of persistent asthma, or asthma with daytime and nighttime symptoms not controlled 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 had not had at least a 14-day wash-out period prior to the run-in period, or had a viral upper respiratory infection within 7 days prior to screening
• Dependence on nasal, oral or ocular decongestants, nasal topical antihistamines, or nasal steroids
• Undergoing a progressive course of immunotherapy (hyposensitization). Subjects on a regular maintenance schedule prior to the screening visit were eligible for study inclusion; however, subject could not receive hyposensitization treatment within 24 hours prior to any study visit
• Diagnosed of cancer within the past 5 years (except for successfully treated basal and squamous cell carcinomas)
• Concomitant medical problem
• Had any of the following clinical conditions: active or quiescent tuberculosis infection of the respiratory tract, untreated fungal, bacterial, systemic viral infections 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 personnel directly involved with this study
• Previously randomized into this study
• Any other clinically significant deviation from normal in the physical examination or medical history that could interfere with the study evaluation or affect subject safety
• 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