A copmarison of beclomethasone aqueous spray and aerosol delivery system in nasal polyps: A randomized control trial

Determination and comparison of the efficacy of aqueous and aerosol beclomethasone sprays in patients with nasal inflammatory polyps

A three phase clinical trial with two intervention groups, in parallel, double-blind, randomized with simple method, with sample size of 70

The present study is a double-blind randomized clinical trial. The target population are the patients referring to Alzahra and Kashani Hospital's clinic with a diagnosis of nasal polyposis during the year 1397-98. Patients are randomly divided into two groups. Patients in the first group are treated with beclomethasone nasal spray 50 µg/dose 2 puff in each nose per day and the second group with oral aerosol spray 50 µg/dose 2 puff in each nose per day. Duration of treatment is 2 months. For the purpose of blinding neither patients nor researcher are aware of the type of treatment each group receives.

Inclusion criteria: Patients from the age of 18-55 years who suffer from inflammatory nasal polyps، Obtaining written consent to participate in the study Exclusion criteria: Previous sensitivity to beclomethasone، Pregnancy or breast-feeding، Severe kidney, heart, liver, neurologic, collagen-vascular, malignancy disease, untreated bacterial or fungal infection ، History of trauma and facial fractures، Use of systemic or topical steroids 30 days before study, nasal decongestant, antihistamines, sodium cromolyn, anticholinergics for 7 previous days, use of cardiovascular drugs, neuroleptics, hormones or any drug that causes allergic rhinitis، Tobacco consumption

Patients in the first group are treated with beclomethasone nasal spray 50 µg/dose 2 puff in each nose per day and the second group with oral aerosol spray 50 µg/dose 2 puff in each nose per day.

The sino-nasal outcomes test-22 score, Lund–Mackay score

The sample was randomly divided into two groups of 35 patients. Each envelope containing one of the two labels A and B represented one of the intervention groups.

For the purpose of blinding, neither the patients nor the researchers were aware of the type of treatment each group received until the completion of the study. The treatments were divided into two groups as closed packages with codes A and B that were assigned to group A packages containing code A and group B packages containing code B.