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Evaluation of Inhaled Treatment in Sinusitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01907204
Recruitment Status : Completed
First Posted : July 24, 2013
Last Update Posted : January 27, 2014
Sponsor:
Information provided by (Responsible Party):
G.Reychler, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Tracking Information
First Submitted Date  ICMJE July 12, 2013
First Posted Date  ICMJE July 24, 2013
Last Update Posted Date January 27, 2014
Study Start Date  ICMJE July 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2013)
Sniffin' Sticks Test [ Time Frame: Baseline and day 15 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 18, 2013)
  • Specific quality of life questionnaire (Snot 20) [ Time Frame: Baseline and day 15 ]
  • Retro Olfaction Test [ Time Frame: Baseline and day 15 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Inhaled Treatment in Sinusitis
Official Title  ICMJE Evaluation of Inhaled Corticosteroid Treatment in Sinusitis
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Sinusitis
Intervention  ICMJE
  • Drug: methylprednisolone
    Oral 32mg/8d-16mg/4d-8mg/4d
  • Drug: Budesonide
    Budesonide by metered dose inhaler
  • Drug: Budesonide
    Budesonide by nebulization
Study Arms  ICMJE
  • Active Comparator: Oral
    Oral drug (methylprednisolone) administration
    Intervention: Drug: methylprednisolone
  • Experimental: Metered dose inhaler
    Intervention: Drug: Budesonide
  • Experimental: Nebulized
    Intervention: Drug: Budesonide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 18, 2013)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Nasal/Sinus polyps

Exclusion Criteria:

  • Previous sinus surgery
  • Age under 18y
  • Use of antibiotics
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01907204
Other Study ID Numbers  ICMJE Sinusitis001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party G.Reychler, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study Sponsor  ICMJE Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gregory Reychler, PhD Cliniques universitaires Saint-Luc
Study Director: Philippe Rombaux, Prof PhD Cliniques universitaires Saint-Luc
Principal Investigator: Coralie Colbrant, PT Cliniques universitaires Saint-Luc
PRS Account Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Verification Date January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP