Comparing the efficacy of a combination of Mometasone and Olopatadine sprays versus Mometasone spray in children with allergic rhinitis

Comparing the effectiveness of the combination of mometasone and olopatadine sprays with mometasone spray in children with allergic rhinitis

Phase 3, two arms parallel group randomized trial, triple blinded, 80 children aged 6-12, using a block randomization method to allocate the patients into two groups. Randomization process will be conducted using random allocation software.

Children referred to allergy clinics of Urmia University of Medical Sciences. The first group will receive two mometasone sprays and Allanthin, administered twice daily at doses of 25 and 665 micrograms, respectively. The second group will receive mometasone spray alone at a dose of 25 micrograms every 12 hours. The sprays will be provided off-label and in identical containers to blind the patients. assess the patients on the 7th, 1st, and 14th days after the study begins through a phone call.

Inclusion criteria: diagnosis of allergic rhinitis by a clinical allergist; age 6-12 years old and written consent from parents. Exclusion criteria: a known history of nasal polyps, other significant abnormalities in the respiratory system; structural abnormalities of the nose; septum deviation; chronic, acute, or severe sinusitis or postpharyngeal discharge and drug-induced rhinitis and active pulmonary disorder or infection or upper respiratory tract or sinus infection within the past 14 days.

The first group consisted of patients who received two sprays of mometasone and allanthin, with doses of 25 and 665 micrograms, respectively, twice daily. The second group included patients who received mometasone spray alone at a dose of 25 micrograms every 12 hours.

Rhinoconjunictivits quality of life and TNSS Questionnaire (Nasal congestion, nasal secretions, nasal itching, sneezing and sleep problems)

The block randomization method will be utilized to assign participants to two groups. The block size will be set at 8, initially listing all possible combinations of AAAABBBBB with a unique code for each. Subsequently, 10 blocks will be randomly selected based on a sample size of n=80, and participants will be allocated according to the order of these chosen blocks. The complete randomization procedure will be conducted using random allocation software overseen by an epidemiology expert.

Blinding will be three-way. The drugs (spray) will be prepared and given to the patients in uniform and identical containers without labels. The list of patients will be listed based on secret codes, which will be available to the researcher, evaluator, and statistical analyzer. Only one nurse outside of the research team will have access to the list to take action on complications.

According to the ethical considerations and policies of the institution (University of Medical Sciences), there will be no sharing of data and it is subject to obtaining the necessary permits.