Back to resultsEvaluation of Inhaled Treatment in Sinusitis
Primary Purpose
Sinusitis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
methylprednisolone
Budesonide
Budesonide
Sponsored by
About this trial
This is an interventional treatment trial for Sinusitis
Eligibility Criteria
Inclusion Criteria:
- Nasal/Sinus polyps
Exclusion Criteria:
- Previous sinus surgery
- Age under 18y
- Use of antibiotics
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Oral
Metered dose inhaler
Nebulized
Arm Description
Oral drug (methylprednisolone) administration
Outcomes
Primary Outcome Measures
Sniffin' Sticks Test
Secondary Outcome Measures
Specific quality of life questionnaire (Snot 20)
Retro Olfaction Test
Full Information
NCT ID
NCT01907204
First Posted
July 12, 2013
Last Updated
January 24, 2014
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
1. Study Identification
Unique Protocol Identification Number
NCT01907204
Brief Title
Evaluation of Inhaled Treatment in Sinusitis
Official Title
Evaluation of Inhaled Corticosteroid Treatment in Sinusitis
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sinusitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oral
Arm Type
Active Comparator
Arm Description
Oral drug (methylprednisolone) administration
Arm Title
Metered dose inhaler
Arm Type
Experimental
Arm Title
Nebulized
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
methylprednisolone
Intervention Description
Oral 32mg/8d-16mg/4d-8mg/4d
Intervention Type
Drug
Intervention Name(s)
Budesonide
Intervention Description
Budesonide by metered dose inhaler
Intervention Type
Drug
Intervention Name(s)
Budesonide
Intervention Description
Budesonide by nebulization
Primary Outcome Measure Information:
Title
Sniffin' Sticks Test
Time Frame
Baseline and day 15
Secondary Outcome Measure Information:
Title
Specific quality of life questionnaire (Snot 20)
Time Frame
Baseline and day 15
Title
Retro Olfaction Test
Time Frame
Baseline and day 15
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Nasal/Sinus polyps
Exclusion Criteria:
Previous sinus surgery
Age under 18y
Use of antibiotics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gregory Reychler, PhD
Organizational Affiliation
Cliniques universitaires Saint-Luc
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Philippe Rombaux, Prof PhD
Organizational Affiliation
Cliniques universitaires Saint-Luc
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Coralie Colbrant, PT
Organizational Affiliation
Cliniques universitaires Saint-Luc
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Inhaled Treatment in Sinusitis
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