Evaluation of Inhaled Treatment in Sinusitis

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status and phase: Completed; Phase 3; Phase 2

Conditions: Sinusitis

Treatments: Drug: methylprednisolone; Drug: Budesonide

Study type: Interventional

Funder types: Other

Identifiers

NCT01907204

Sinusitis001

Details and patient eligibility

About

The purpose of this study is to determine whether inhaled corticosteroid (specially nebulized) could be a good alternative to oral corticosteroid and whether they are effective in the treatment of sinusitis

Enrollment: 50 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Nasal/Sinus polyps

Exclusion criteria

• Previous sinus surgery
• Age under 18y
• Use of antibiotics

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 3 patient groups

Oral

Active Comparator group

Description:

Oral drug (methylprednisolone) administration

Treatment:

Drug: methylprednisolone

Metered dose inhaler

Experimental group

Treatment:

Drug: Budesonide

Drug: Budesonide

Nebulized

Experimental group

Treatment:

Drug: Budesonide

Drug: Budesonide