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Evaluation of Inhaled Treatment in Sinusitis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
G.Reychler, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT01907204
First received: July 12, 2013
Last updated: January 24, 2014
Last verified: January 2014
  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
Endpoint Classification: Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Specific quality of life questionnaire (Snot 20) [ Time Frame: Baseline and day 15 ] [ Designated as safety issue: No ]
  • Retro Olfaction Test [ Time Frame: Baseline and day 15 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Nasal/Sinus polyps

Exclusion Criteria:

  • Previous sinus surgery
  • Age under 18y
  • Use of antibiotics
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: July 12, 2013
Last Updated: January 24, 2014
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP
Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Institutional Review Board

Additional relevant MeSH terms:
Sinusitis
Nose Diseases
Otorhinolaryngologic Diseases
Paranasal Sinus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Budesonide
Methylprednisolone
Methylprednisolone Hemisuccinate
Methylprednisolone acetate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Antiemetics
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Autonomic Agents
Bronchodilator Agents
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014