Evaluation of Inhaled Treatment in Sinusitis

Phase 2

Completed

• Conditions: Sinusitis
• Interventions: Drug: methylprednisolone; Drug: Budesonide

• Registration Number: NCT01907204
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-07-12
• Study First Submitted QC: 2013-07-18
• Study First Posted: 2013-07-24
• Primary Completion: 2013-08
• Status Verified: 2014-01
• Study Completion: 2014-01
• Last Update Submitted: 2014-01-24
• Last Update Posted: 2014-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Nasal/Sinus polyps

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral	methylprednisolone	Oral drug (methylprednisolone) administration
Metered dose inhaler	Budesonide	-
Nebulized	Budesonide	-

Primary Outcome Measures

Name	Time	Method
Sniffin' Sticks Test	Baseline and day 15

Secondary Outcome Measures

Name	Time	Method
Specific quality of life questionnaire (Snot 20)	Baseline and day 15
Retro Olfaction Test	Baseline and day 15