Is Pentoxifylline Able to Improve Olfactory Sensitivity?

Olfaction Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00660868
• Other study ID #: EK157072007
• Status: Completed
• Phase: N/A
• First received: April 16, 2008
• Last updated: February 4, 2016
• Start date: November 2009
• Est. completion date: January 2016

Study information

• Verified date: February 2016
• Source: Technische Universität Dresden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Olfaction Disorders

Intervention

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

Locations

Country	Name	City	State
Germany	Zentrum für Riechen und Schmecken, Universitäts- HNO- Klinik Dresden	Dresden

Sponsors (1)

Lead Sponsor	Collaborator
Technische Universität Dresden

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TDI-score		at day 0 and follow up after 3 weeks	No
Secondary	odor threshold odor discrimination odor identification		at day 0 and at follow up after 3 weeks	No