Clinical Study, Non Inferiority Between Noex® 50µg Versus Busonid® 50µg in Treatment of Allergic Rhinitis

Phase III, Multicenter, Randomized, Simple-blinded, Parallel Groups to Evaluate Non Inferiority of Noex® 50µg Versus Busonid® 50µg in Treatment of Allergic Persistent Rhinitis Moderate to Severe

This study is to evaluate non inferiority of Eurofarma budesonide nasal spray x referral Astrazeneca budesonide. Half patients will receive Eurofarma medication and half patients will receive Astrazeneca medication. There is no placebo group.

Budesonide is a medicine already very used and registered about 20 years. Eurofarma has the intention to collect more data about safety and efficacy and present them to local authority.

This study was draw to treat patients with persistent rhinitis moderate to severe in sites located locally in Brazil.

Inclusion Criteria:

1. Age ≥ 12
2. History of allergic persistent rhinitis moderate to severe at least 2 years
3. Proved allergic using PRICK or RAST test
4. Nasal symptoms (NIS) > 3 and nasal obstruction >1
5. Indication of nasal corticosteroids use
6. Washout of nasal corticosteroids for 14 days
7. ICF

Exclusion Criteria:

1. Other types of rhinitis
2. Asthma non controlled
3. Use of oral/injectable corticoids 30 days before screening
4. patients not eligible to complete diaries
5. patients with allergy to any substance of medicines
6. non controlled disease