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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):

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

Condition or disease Intervention/treatment Phase
Sinusitis Drug: methylprednisolone Drug: Budesonide Phase 2 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Inhaled Corticosteroid Treatment in Sinusitis
Study Start Date : July 2013
Primary Completion Date : August 2013
Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sinusitis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: July 24, 2013    Key Record Dates
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
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Budesonide
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Bronchodilator Agents
Anti-Asthmatic Agents
Respiratory System Agents