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Evaluation of Inhaled Treatment in Sinusitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01907204
First Posted: July 24, 2013
Last Update Posted: January 27, 2014
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.
Information provided by (Responsible Party):
G.Reychler, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
  Purpose
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
Sinusitis Drug: methylprednisolone Drug: Budesonide Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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 G.Reychler, 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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Nasal/Sinus polyps

Exclusion Criteria:

  • Previous sinus surgery
  • Age under 18y
  • Use of antibiotics
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01907204


Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
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
ClinicalTrials.gov Identifier: NCT01907204     History of Changes
Other Study ID Numbers: Sinusitis001
First Submitted: July 12, 2013
First Posted: July 24, 2013
Last Update Posted: January 27, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Prednisolone acetate
Methylprednisolone acetate
Budesonide
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
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
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antiemetics
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents