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Elaboration of Patient-friendly Treatment Strategy With Capsaicin Nasal Spray in Patients With Idiopathic Rhinitis

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ClinicalTrials.gov Identifier: NCT02288156
Recruitment Status : Completed
First Posted : November 11, 2014
Results First Posted : January 12, 2021
Last Update Posted : January 12, 2021
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Study Description
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Brief Summary:

Chronic rhinitis is affecting more than 200 million people worldwide. Its prevalence is estimated to be as high as 30% of the Western population. Rhinitis is defined as symptomatic inflammation of the inner lining of the nose and is characterized by the following symptoms: rhinorrhea, nasal blockage, nasal itching and/or sneezing. The cut-off point for defining rhinitis as chronic rhinitis is considered to be persisting symptoms for over more than twelve weeks Chronic rhinitis can be divided into three major subgroups; based on the knowledge of the major etiological factor: infectious rhinitis, allergic rhinitis and non-allergic, non-infectious rhinitis, in literature also referred to as nonallergic rhinitis. Non-inferiority in efficacy of the two novel treatment regimes i.e. capsaicin nasal spray 0,01mM (2puffs/nostril/day) during 4 weeks and capsaicin nasal spray 0,001mM (2puffs/nostril/day) during 4 weeks compared to the current treatment of capsaicin nasal spray 0,1mM (5/day administered on a single day) with regard to the change from baseline in VAS for major nasal symptom on week 4.

(Estimated placebo effect is 25%.)


Condition or disease Intervention/treatment Phase
Non-allergic Rhinitis Drug: Capsaicin Drug: placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Elaboration of Patient-friendly Treatment Strategy With Capsaicin Nasal Spray in Patients With Idiopathic Rhinitis
Study Start Date : July 2015
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Capsaicin

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 0,1mM Drug: Capsaicin
via nasal spray
Experimental: 0,01mM Drug: Capsaicin
via nasal spray
Experimental: 0.001mM Drug: Capsaicin
via nasal spray
Placebo Comparator: Placebo Drug: placebo
via nasal spray


Outcome Measures
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Primary Outcome Measures :
  1. Change in Visual Analogue Scale for Major Nasal Symptoms [ Time Frame: week 4 ]
    patients score their main nasal complaints from 0 to 10 on a scale of 10, with 0 meaning no complaints and 10 meaning the worst complaints. This is done at baseline and after 4 weeks of treatment


Secondary Outcome Measures :
  1. Change in Visual Analogue Scale for Individual Nasal Symptoms [ Time Frame: week 4 ]
    patients score all kinds of nasal symptoms from 0 to 10 on a scale of 10, with 0 meaning no complaints and 10 meaning the worst complaints. This is done at baseline and after 4 weeks of treatment

  2. Change in Therapeutic Response in All Treatment Regimes [ Time Frame: week 4 ]
    Evaluation of the therapeutic response (TRE) on a scale from 1 (= no relief of symptoms) to 5 (= total relief of symptoms).

  3. Change of Nasal Hyperreactivity in All Treatment Modalities. [ Time Frame: week 4 ]
  4. Evaluation of Appearance of Adverse Events in All Treatment Groups [ Time Frame: week 4 ]
  5. Evaluation of Recurrence of Symptoms in All Treatment Modalities [ Time Frame: week 4, 12 and 26 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • idiopathic rhinitis patients with at least 2 persistent (> 12w) rhinological symptoms (nasal discharge, sneezing, nasal congestion) for an average of at least 1 h per day,
  • idiopathic rhinitis patients with a total nasal symptoms score (TNS) of 5 or more on a visual analogue scale (VAS).
  • Age > 18 and < 65 years.
  • Written informed consent.
  • Willingness to adhere to visit schedules.
  • Adequate contraceptive precautions in female patients with childbearing potential.

Exclusion Criteria:

  • Patients with concomitant allergic rhinitis, demonstrated by positive skin prick test (Hal reagents) and/or immunoglobins E in blood. *
  • Patients with structural abnormalities: nasal polyps, severe septal deviation (septum reaching concha inferior or lateral nasal wall), septal perforation, hypertrophy of the inferior turbinates.
  • Patients with local allergic rhinitis (LAR) or entopy.
  • Systemic steroid treatment less than 4 weeks before the inclusion in the study, nasal steroid spray less than 4 weeks before the inclusion, oral leukotriene antagonists or long-acting antihistamines less than 2 weeks before the inclusion.
  • Inability of the patient to stop taking medication affecting nasal function like ß-blockers.
  • History of prolonged use or abuse of decongestant nasal spray like xylometazoline spray and/or use or abuse of decongestive oral medication.
  • Evidence of infectious rhinitis/rhinosinusitis or common cold within 4 weeks prior to inclusion.
  • Pregnancy or lactation. **
  • Any disorder of which might compromise the ability of a patient to give truly informed consent for participation in this study.
  • Enrollment in other investigational drug trial(s) or receiving other investigational agent(s) for any other medical condition.
  • Contra-indications for the use of local anesthesia (cocaine 5%).
  • Smoking or occupational exposure to irritants (like hypochlorite, persulfates, isocyanates).
  • Nasal malignancies or severe comorbidity like granulomatosis or vasculitis.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02288156


Locations
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Belgium
ORL
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
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Principal Investigator: Peter Hellings, Prof. Dr. UZ Leuven
  Study Documents (Full-Text)

Documents provided by Universitaire Ziekenhuizen Leuven:
Study Protocol and Statistical Analysis Plan  [PDF] December 9, 2015

More Information
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Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT02288156    
Other Study ID Numbers: TBM
First Posted: November 11, 2014    Key Record Dates
Results First Posted: January 12, 2021
Last Update Posted: January 12, 2021
Last Verified: December 2020
Additional relevant MeSH terms:
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Common Cold
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Picornaviridae Infections
RNA Virus Infections
 Virus Diseases
Capsaicin
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs