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NCT01907204 Clinical Trial

Evaluation of Inhaled Treatment in Sinusitis

Sinusitis Clinical Trial

Official title:
Evaluation of Inhaled Corticosteroid Treatment in Sinusitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01907204
Other study ID # Sinusitis001
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received July 12, 2013
Last updated January 24, 2014
Start date July 2013
Est. completion date January 2014

Study information
Verified date January 2014
Source Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicines and Health Products, FAMHPBelgium: Federal Agency for Medicinal Products and Health ProductsBelgium: Institutional Review Board
Study type Interventional

Clinical Trial 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

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date January 2014
Est. primary completion date August 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- Nasal/Sinus polyps

Exclusion Criteria:

- Previous sinus surgery

- Age under 18y

- Use of antibiotics

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• methylprednisolone
Oral 32mg/8d-16mg/4d-8mg/4d
• Budesonide
Budesonide by metered dose inhaler
• Budesonide
Budesonide by nebulization

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Outcome
Type Measure Description Time frame Safety issue
Primary Sniffin' Sticks Test Baseline and day 15 No
Secondary Specific quality of life questionnaire (Snot 20) Baseline and day 15 No
Secondary Retro Olfaction Test Baseline and day 15 No
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