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Is Pentoxifylline Able to Improve Olfactory Sensitivity?

This study is currently recruiting participants.
Verified by Dresden University of Technology, April 2008

Sponsored by: Dresden University of Technology
Information provided by: Dresden University of Technology
ClinicalTrials.gov Identifier: NCT00660868
  Purpose

Signal processing in the olfactory neuron could be influenced by inhibition of enzymes like phosphodiesterase. Pentoxifylline is a unspecific phosphodiesterase inhibitor. The hypothesis is that pentoxifylline could lead to increased sensitivity to odors.


Condition Intervention
Olfaction Disorders
Drug: Pentoxifylline retard 400mg

MedlinePlus related topics:   Taste and Smell Disorders   

ChemIDplus related topics:   Pentoxifylline    Pentoxyl   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Other, Prospective
Official Title:   Agapurin Retard Used in Patients With Smell Disorder- A Post-Marketing Observational Study

Further study details as provided by Dresden University of Technology:

Primary Outcome Measures:
  • TDI-score [ Time Frame: at day 0 and follow up after 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • odor threshold odor discrimination odor identification [ Time Frame: at day 0 and at follow up after 3 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment:   30
Study Start Date:   November 2007
Estimated Study Completion Date:   November 2009
Estimated Primary Completion Date:   November 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts Assigned Interventions
1
Patients with posttraumatic, idiopathic, and postinflammatory cause of smell loss; patients age between 18 and 50 years. Odor threshold better than 1.
Drug: Pentoxifylline retard 400mg
Agapurin retard 400mg 3/day per os for 3 weeks

Detailed Description:

Olfactory signal processing is conducted by a G-protein linked increase of intracellular concentration of adenosine 3´,5´-cyclic monophosphate (cAMP). In the cilia of olfactory sensory neurons (OSN) cAMP is degraded by phosphodiesterase 1C2 (PDE1C2). Inhibition of PDE1C2 could result in an increased response of OSN to chemical stimuli. Aim of the present prospective post-marketing surveillance study was to investigate the impact of pentoxifylline, an unspecific phosphodieasterase inhibitor, on olfactory function.

  Eligibility
Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample

Study Population

hyposmic or functionally anosmic patients TDI-score <31; age: 18-50 years; odor threshold: better than 1; cause of smell loss: post traumatic, postinflammatory, idiopathic


Criteria

Inclusion Criteria:

  • hyposmic or functionally anosmic patients TDI-score <31
  • age: 18-50 years
  • odor threshold: better than 1
  • cause of smell loss: post traumatic, postinflammatory, idiopathic

Exclusion Criteria:

  • normosmic patients,
  • patients with contraindications for application of pentoxifylline
  • patients that cannot give written agreement to the study
  • patients under 18 years and over 50 years of age
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00660868

Contacts
Contact: Volker Gudziol, Dr. med.     49-351-458-4420     volker.gudziol@uniklinikum-dresden.de    
Contact: Thomas Hummel, Prof. Dr.     49-351-458-4189     thummel@mail.zih.tu-dresden.de    

Locations
Germany
Zentrum für Riechen und Schmecken, Universitäts- HNO- Klinik Dresden     Recruiting
      Dresden, Germany, 01307
      Contact: Thomas Hummel, Prof. Dr.     49-351-458-4189     thummel@mail.zih.tu-dresden.de    
      Principal Investigator: Volker Gudziol, Dr. med.            
      Sub-Investigator: Thomas Hummel, Prof. Dr.            

Sponsors and Collaborators
Dresden University of Technology

Investigators
Principal Investigator:     Volker Gudziol, Dr. med.     Technische Universität Dresden    
  More Information

Responsible Party:   Smell and Taste clinic, Klinik für HNO- Heilkunde, Universitätsklinikum Dresden ( Gudziol, Dr. med. )
Study ID Numbers:   EK157072007
First Received:   April 16, 2008
Last Updated:   April 16, 2008
ClinicalTrials.gov Identifier:   NCT00660868
Health Authority:   Germany: Ethics Commission

Keywords provided by Dresden University of Technology:
smell  
olfaction  
olfactory sensitivity  
smell loss  
chemoreception  

Study placed in the following topic categories:
Signs and Symptoms
Sensation Disorders
Olfaction Disorders
Neurologic Manifestations
Pentoxifylline

Additional relevant MeSH terms:
Vasodilator Agents
Radiation-Protective Agents
Antioxidants
Disease
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Hematologic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Cardiovascular Agents
Protective Agents
Pharmacologic Actions
Pathologic Processes
Phosphodiesterase Inhibitors
Therapeutic Uses
Free Radical Scavengers
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on August 29, 2008




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