Prednisone in Chronic Rhinosinusitis Without Nasal Polyps

• Register: ClinicalTrials.gov
• Last refreshed on: 29 June 2015
• Main ID: NCT02367118
• Date of registration: 08/02/2015
• Prospective Registration: Yes
• Primary sponsor: University of Chile
• Public title: Prednisone in Chronic Rhinosinusitis Without Nasal Polyps
• Scientific title: Prednisone in Chronic Rhinosinusitis Without Nasal Polyps. A Double-blind, Randomized, Placebo-controlled Trial
• Date of first enrolment: June 2015
• Target sample size: 90
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT02367118
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Chile

Contacts

• Name: Constanza J Valdes, MD

• Name: Marcela A Veloz, MD
• Affiliation: University of Chile

• Name: Constanza J Valdes, MD
• Affiliation: University of Chile

• Name: Constanza J Valdes, MD

Key inclusion & exclusion criteria

Inclusion Criteria:

- Diagnosis of CRSsNP as recommended European Position Paper on Rhinosinusitis and
Nasal Polyps 2012

Exclusion Criteria:

- Treatment with oral corticosteroids or topical corticosteroids the last 4 weeks.

- Previous surgical treatment for CRSsNP

- History of diabetes mellitus and / or glaucoma and / or decompensated hypertension
and / or gastric ulcer.

- Pregnancy.

- History of cystic fibrosis, primary ciliary dyskinesia, immunodeficiency, allergic
fungal sinusitis, nasal polyps, nasal tumors, hepatic or renal dysfunction.

- Hypersensitivity to prednisone



Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Rhinosinusitis

Sinusitis

Intervention(s)

Drug: Prednisone

Drug: Placebo

Primary Outcome(s)

Changes in Symptoms as measured by SNOT 22 questionnaire and visual analogue scale at 6 months [Time Frame: Improvement in symptoms at the end (average of 25 days is expected) of the administration of prednisone (intervention), one month, three months and six months after the end of intervention compared to placebo]

Change in Olfactory function as measured by "Sniffin'Sticks 12 tests" at 6 months [Time Frame: Improvement in Olfactory function at the end (average of 25 days is expected) of the administration of prednisone (intervention), one month, three months and six months after the end of intervention compared to placebo]

Change in Nasal patency as measured by Acoustic rhinometry and Rhinomanometry at 6 months [Time Frame: Improvement in nasal patency at the end (average of 25 days is expected) of the administration of prednisone (intervention), one month, three months and six months after the end of intervention compared to placebo]

Changes in Nasal endoscopy findings as measured by Lund-Kennedy score at 6 months [Time Frame: Changes in nasal endoscopy findings at the end (average of 25 days is expected) of the administration of prednisone (intervention), one month, three months and six months after the end of intervention compared to placebo]

Secondary ID(s)

PRD- CRSsNP-1

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Sociedad Chilena de Otorrinolaringología, Medicina y Cirugía de Cabeza y Cuello