Is Pentoxifylline Able to Improve Olfactory Sensitivity? - Full Text View

Sponsor:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Taste and Smell Disorders

Drug Information available for: Pentoxyl Pentoxifylline

U.S. FDA Resources

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

No publications provided

Responsible Party:	Smell and Taste clinic, Klinik für HNO- Heilkunde, Universitätsklinikum Dresden ( Gudziol, Dr. med. )
Study ID Numbers:	EK157072007
Study First Received:	April 16, 2008
Last Updated:	January 29, 2009
ClinicalTrials.gov Identifier:	NCT00660868 History of Changes
Health Authority:	Germany: Ethics Commission

Keywords provided by Dresden University of Technology:

smell
olfaction
olfactory sensitivity
smell loss
chemoreception

Additional relevant MeSH terms:

Sensation Disorders
Vasodilator Agents
Radiation-Protective Agents
Antioxidants
Disease
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Hematologic Agents
Nervous System Diseases
Enzyme Inhibitors
Cardiovascular Agents

Protective Agents
Pentoxifylline
Pharmacologic Actions
Signs and Symptoms
Olfaction Disorders
Pathologic Processes
Phosphodiesterase Inhibitors
Therapeutic Uses
Free Radical Scavengers
Neurologic Manifestations
Platelet Aggregation Inhibitors

ClinicalTrials.gov processed this record on November 30, 2009