Clinical Study, Non Inferiority Between Noex® 50µg Versus Busonid® 50µg in Treatment of Allergic Rhinitis (RINEX50)

Eurofarma

Status and phase: Withdrawn; Phase 3

Conditions: Rhinitis, Allergic, Perennial

Treatments: Drug: Budesonid 50mcg (Noex); Drug: Budesonid 50mcg (Busonid)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02988778

EF149

Details and patient eligibility

About

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.

Full description

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.

Sex: All

Ages: 12 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

0 participants in 2 patient groups

Budesonid 50mcg (Noex)

Experimental group

Description:

Budesonid 50mcg (Noex), 2 atomizations in each nostril by the morning and during the night, total of 400 mcg per day. Treatment of 28 days.

Treatment:

Drug: Budesonid 50mcg (Noex)

Budesonid 50mcg (Busonid)

Active Comparator group

Description:

Budesonid 50mcg (Busonid), 2 atomizations in each nostril by the morning and during the night, total of 400 mcg per day. Treatment of 28 days.

Treatment:

Drug: Budesonid 50mcg (Busonid)