Mechanisms of Capsaicin Treatment in Idiopathic Rhinitis Patients and Controls

NCT01862523 | Completed Phase 4 DMC

• 1 other identifier: mucosal potentials in the nose
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

Capsaicin nasal spray is used in daily practice against IR without knowledge about the exact mechanisms involved in this treatment. Therefore, this study aims to address this issue by studying the functional (electrophysiologic) changes after specific stimulations in IR patients and healthy controls before and after capsaicin/placebo treatment.

Conditions

Rhinitis

Outcome Measures

Primary Outcomes (1)

• negative mucosa potentials

  change in negative mucosa potentials (baseline vs 1, 3 and 6 months after treatment)by measurement of AUC, delay-time and amplitude

  baseline, 1, 3 and 6 months

Secondary Outcomes (1)

• visual analogue scale

  baseline, 1, 3 and 6 months

Study Arms (3)

diluent

PLACEBO COMPARATOR

diluent

Biological: diluent

capsaicin

EXPERIMENTAL

capsaicin

Biological: Capsaicin

control healthy volunteers

NO INTERVENTION

control healthy volunteers

Interventions

Capsaicin BIOLOGICAL

Thirty-three\* well-characterized IR patients will be recruited and screened for participation in this study with nasal capsaicin spray (0,1 mmol/l ) using the treatment regimen described by van Rijswijk et al. (1 x 5 applications in one day, with 1 hour between each application)

capsaicin

diluent BIOLOGICAL

diluent

diluent

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with persistent (\> 52w) rhinological symptoms: nasal discharge, sneezing, congestion for an average of at least 1 h per day for at least 5 days during a period of 14 days, negative skin prick test or negative RAST, and without structural abnormalities explaining nasal obstruction will be proposed to participate in the trial.
• Age \> 18 and \< 60 years
• Written informed consent
• Willingness to adhere to visit schedules
• Adequate contraceptive precautions in female patients with childbearing potential
• Unresponsiveness to nasal steroid spray (4 weeks of use)

You may not qualify if:

• Age \< 18 and \> 60 years
• Patients with AR, demonstrated by either positive skin prick test or RAST
• Asthma
• Structural abnormalities: nasal polyps, severe septal deviation (septum reaching concha inferior or lateral nasal wall.
• Inability of the patient to stop taking medication affecting nasal function.
• Evidence of infectious rhinitis/rhinosinusitis.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

UZ Leuven

Leuven, Vlaams-Brabant, 8000, Belgium

Location

MeSH Terms

Conditions

Rhinitis

Interventions

Capsaicin

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids

Study Officials

• Laura Van Gerven, Doctor

  UZ Leuven

  PRINCIPAL INVESTIGATOR

• Peter Hellings, Doctor

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2012
• First Posted: May 24, 2013
• Study Start: February 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 5, 2014

Record last verified: 2014-12

Locations

BE (1)