Clinical trial NCT00599027 (phase 3, status: completed)
Conditions: allergic rhinitis, asthma
ICD codes: J30.89, J30.9, J30.2, J30.1, J30.5, J30.81, J45.998, J82.83, J45.909, J45.991, J45.20, J45.30, J45.40
Drugs: mometasone furoate nasal spray (mfns), placebo nasal spray
SMILES: [H][C@@]12C[C@@H](C)[C@](O)(C(=O)CCl)[C@@]1(C)C[C@H](O)[C@@]1(Cl)[C@@]2([H])CCC2=CC(=O)C=C[C@]12C, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
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