Official Title: “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 Type: Observational

Study Design: Other, Prospective

Study Primary Completion Date: November 2009

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.

Intervention(s) in this Clinical Trial

• Drug: Pentoxifylline retard 400mg
  • Agapurin retard 400mg 3/day per os for 3 weeks

Arms, Groups and Cohorts in this Clinical Trial

• : 1
  • Patients with posttraumatic, idiopathic, and postinflammatory cause of smell loss; patients age between 18 and 50 years. Odor threshold better than 1.

Primary Measures

• TDI-score
  • Time Frame: at day 0 and follow up after 3 weeks
    Safety Issue?: No

Secondary Measures

• odor threshold odor discrimination odor identification
  • Time Frame: at day 0 and at follow up after 3 weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Dresden University of Technology

Overall Clinical Trial Officials and Contacts

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

Overall Contact: Volker Gudziol, Dr. med. 49-351-458-4420 volker.gudziol@uniklinikum-dresden.de

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00660868

Study ID Number: EK157072007

ClinicalTrials.gov Identifier: NCT00660868

Health Authority: Germany: Ethics Commission