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Is Pentoxifylline Able to Improve Olfactory Sensitivity?

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. Identifier: NCT00660868
Recruitment Status : Completed
First Posted : April 17, 2008
Last Update Posted : February 5, 2016
Information provided by (Responsible Party):
Technische Universität Dresden

Brief Summary:
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 or disease Intervention/treatment
Olfaction Disorders Drug: Pentoxifylline retard 400mg

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.

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Study Type : Observational
Actual Enrollment : 7 participants
Time Perspective: Prospective
Official Title: Agapurin Retard Used in Patients With Smell Disorder- A Post-marketing Observational Study
Study Start Date : November 2009
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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
Other Name: Agapurin retard

Primary Outcome Measures :
  1. TDI-score [ Time Frame: at day 0 and follow up after 3 weeks ]

Secondary Outcome Measures :
  1. odor threshold odor discrimination odor identification [ Time Frame: at day 0 and at follow up after 3 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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

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

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 identifier (NCT number): NCT00660868

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Zentrum für Riechen und Schmecken, Universitäts- HNO- Klinik Dresden
Dresden, Germany, 01307
Sponsors and Collaborators
Technische Universität Dresden
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Principal Investigator: Volker Gudziol, Dr. med. Technische Universität Dresden
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Responsible Party: Technische Universität Dresden Identifier: NCT00660868    
Other Study ID Numbers: EK157072007
First Posted: April 17, 2008    Key Record Dates
Last Update Posted: February 5, 2016
Last Verified: February 2016
Keywords provided by Technische Universität Dresden:
olfactory sensitivity
smell loss
Additional relevant MeSH terms:
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Olfaction Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Vasodilator Agents
Free Radical Scavengers