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Evaluation of Inhaled Treatment in Sinusitis

This study has been completed.
Information provided by (Responsible Party):
G.Reychler, Cliniques universitaires Saint-Luc- Université Catholique de Louvain Identifier:
First received: July 12, 2013
Last updated: January 24, 2014
Last verified: January 2014
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

Condition Intervention Phase
Drug: methylprednisolone
Drug: Budesonide
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Inhaled Corticosteroid Treatment in Sinusitis

Resource links provided by NLM:

Further study details as provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:

Primary Outcome Measures:
  • Sniffin' Sticks Test [ Time Frame: Baseline and day 15 ]

Secondary Outcome Measures:
  • Specific quality of life questionnaire (Snot 20) [ Time Frame: Baseline and day 15 ]
  • Retro Olfaction Test [ Time Frame: Baseline and day 15 ]

Enrollment: 50
Study Start Date: July 2013
Study Completion Date: January 2014
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Oral
Oral drug (methylprednisolone) administration
Drug: methylprednisolone
Oral 32mg/8d-16mg/4d-8mg/4d
Experimental: Metered dose inhaler Drug: Budesonide
Budesonide by metered dose inhaler
Experimental: Nebulized Drug: Budesonide
Budesonide by nebulization


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Nasal/Sinus polyps

Exclusion Criteria:

  • Previous sinus surgery
  • Age under 18y
  • Use of antibiotics
  Contacts and Locations
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Please refer to this study by its identifier: NCT01907204

Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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
  More Information

Responsible Party: G.Reychler, Docteur Gregory Reychler, Cliniques universitaires Saint-Luc- Université Catholique de Louvain Identifier: NCT01907204     History of Changes
Other Study ID Numbers: Sinusitis001
Study First Received: July 12, 2013
Last Updated: January 24, 2014

Additional relevant MeSH terms:
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents processed this record on May 25, 2017