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

• Status: Withdrawn
• Trial end date: 2019-10-08
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Eurofarma Laboratorios S.A.

Criteria

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