Intervention: Elocon
Trial phase: Phase 3
ATC code: D07AC13 | D07XC03 | R01AD09 | R03AK09 | R03BA07
SMILES: CC1CC2C3CCC4=CC(=O)C=CC4(C)C3(Cl)C(O)CC2(C)C1(OC(=O)c1ccco1)C(=O)CCl
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 51
Group description: Mometasone furoate nasal spray (MFNS) 200 mcg once daily (two 50 mcg puffs per nostril) in the morning.
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