An Exploratory Study of Nasonex in Patients With Moderate to Severe Persistent Allergic Rhinitis and Intermittent Asthma
Condition: Allergic Rhinitis; Asthma
MeSH terms: Rhinitis; Asthma; Rhinitis, Allergic
Intervention: Mometasone furoate nasal spray (MFNS); Placebo nasal spray
Intervention description: Mometasone furoate nasal spray (MFNS) 200 mcg once daily (two 50 mcg puffs per nostril) in the morning.; Placebo nasal spray once daily (two puffs per nostril) in the morning.
Intervention MeSH terms: Mometasone Furoate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 51.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      The primary objective of this study is to explore the efficacy of Nasonex (mometasone furoate
      nasal spray) in comparison with placebo in improving the quality of life of subjects with
      moderate to severe persistent allergic rhinitis and intermittent asthma. A secondary
      objective is to evaluate the efficacy of Nasonex in relieving the subject's symptoms of
      allergic rhinitis and asthma.
    

Eligibility criteria:

        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