Is Pentoxifylline Able to Improve Olfactory Sensitivity?

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Technische Universität Dresden.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Technische Universität Dresden
ClinicalTrials.gov Identifier:
NCT00660868
First received: April 16, 2008
Last updated: June 22, 2011
Last verified: June 2011
  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: Time Perspective: Prospective
Official Title: Agapurin Retard Used in Patients With Smell Disorder- A Post-marketing Observational Study

Resource links provided by NLM:


Further study details as provided by Technische Universität Dresden:

Primary Outcome Measures:
  • TDI-score [ Time Frame: at day 0 and follow up after 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • odor threshold odor discrimination odor identification [ Time Frame: at day 0 and at follow up after 3 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2009
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2011 (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
Other Name: Agapurin retard

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00660868

Contacts
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

Locations
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.         
Sponsors and Collaborators
Technische Universität Dresden
Investigators
Principal Investigator: Volker Gudziol, Dr. med. Technische Universität Dresden
  More Information

No publications provided

Responsible Party: Gudziol, Dr. med., Smell and Taste clinic, Klinik für HNO- Heilkunde, Universitätsklinikum Dresden
ClinicalTrials.gov Identifier: NCT00660868     History of Changes
Other Study ID Numbers: EK157072007
Study First Received: April 16, 2008
Last Updated: June 22, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Technische Universität Dresden:
smell
olfaction
olfactory sensitivity
smell loss
chemoreception

Additional relevant MeSH terms:
Olfaction Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Pentoxifylline
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Platelet Aggregation Inhibitors
Hematologic Agents
Therapeutic Uses
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs
Vasodilator Agents
Cardiovascular Agents
Free Radical Scavengers
Antioxidants

ClinicalTrials.gov processed this record on July 22, 2014