Is Pentoxifylline Able to Improve Olfactory Sensitivity?

February 4, 2016 updated by: Technische Universität Dresden

Agapurin Retard Used in Patients With Smell Disorder- A Post-marketing Observational Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

7

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Dresden, Germany, 01307
        • Zentrum für Riechen und Schmecken, Universitäts- HNO- Klinik Dresden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 46 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Other Names:
  • Agapurin retard

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
TDI-score
Time Frame: at day 0 and follow up after 3 weeks
at day 0 and follow up after 3 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
odor threshold odor discrimination odor identification
Time Frame: at day 0 and at follow up after 3 weeks
at day 0 and at follow up after 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technische Universität Dresden

Investigators

  • Principal Investigator: Volker Gudziol, Dr. med., Technische Universität Dresden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

April 16, 2008

First Submitted That Met QC Criteria

April 16, 2008

First Posted (Estimate)

April 17, 2008

Study Record Updates

Last Update Posted (Estimate)

February 5, 2016

Last Update Submitted That Met QC Criteria

February 4, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK157072007

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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