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| 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 |
| 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
|
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 |
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
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| 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 |
| 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. | |
| 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 |
| Study First Received: | April 16, 2008 |
| Last Updated: | January 29, 2009 |
| ClinicalTrials.gov Identifier: | NCT00660868 History of Changes |
| Health Authority: | Germany: Ethics Commission |
|
smell olfaction olfactory sensitivity smell loss chemoreception |
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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 |