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

• Status: Withdrawn
• Trial end date: 2019-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eurofarma Laboratorios S.A.
• Treatments: Budesonide

Criteria

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.