Clinical Study, Non Inferiority Between Noex® 32µg Versus Budecort Aqua® 32µg in Treatment of Alergic Rhinitis

Phase III, Multicenter, Randomized, Simple-blinded, Paralel Groups to Evaluate Non Inferiority of Noex® 32µg Versus Budecort Aqua® 32µg in Treatment of Alergic Persistent Rhinitis Moderate to Severe

This study is to evaluate non inferiority of Eurofarma budesonide nasal spary 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 persisntent rhinits moderate to severe in sites localted locally in Brasil.

Inclusion Criteria:

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

Exclusion Criteria:

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