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Intranasal Capsaicin Treatment for Non-Allergic Irritant Rhinitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02493257
Recruitment Status : Completed
First Posted : July 9, 2015
Results First Posted : August 17, 2020
Last Update Posted : August 17, 2020
Sponsor:
Collaborator:
American Academy of Otolaryngic Allergy
Information provided by (Responsible Party):
Denna Awni Zebda, The University of Texas Health Science Center, Houston

Brief Summary:
The proposed study seeks to investigate the effect of intranasal capsaicin treatment in patient with Non-allergic irritant rhinitis (NAIR), as well as evaluate optical rhinometry (ORM) as a means to quantify symptomatic improvement in NAIR patients during and after treatment.

Condition or disease Intervention/treatment Phase
Nonallergic Irritant Rhinitis Drug: Capsaicin Drug: Placebo Phase 2

Detailed Description:

A study by Lambert et. al. (2012) was able to objectively identify patients with NAIR by intranasal capsaicin challenge followed by assessment with optical rhinometry. Studies have shown that capsaicin therapy can improve symptoms of patients historically identified with NAIR via visual analog scale (VAS) rating of symptoms and symptom surveys; however, there has been no study evaluating the capsaicin therapy on patients objectively identified as NAIR patients.

Multiple studies have demonstrated that intranasal capsaicin can improve nasal symptoms of NAIR patients. Regarding the usage of capsaicin, there is a product on the market: Sinus Buster which has capsaicin as the active ingredient. Numerous research papers have evaluated the efficacy and safety of Sinus Buster for the treatment of congestion in non-allergic rhinitis patients. However, the diagnosis of NAIR in these previous studies was based primarily on history. In addition, the primary outcome in these studies was symptomatic without any objective evaluation. The goal of this study will be two-fold: with patients objectively identified as NAIR patients via the optical rhinometer, we will re-evaluate the therapeutic action of intranasal capsaicin on the management of rhinitic symptoms. We expect that the patients will show significant improvement in their symptoms. We will then use optical rhinometry as a means to objectively monitor changes in symptoms in NAIR patients. We expect that post treatment, patients will no longer have the positive response previously seen on intranasal capsaicin challenge before receiving treatment. We hope to be able to establish optical rhinometry as an objective measurement of symptom improvement for NAIR symptoms, along with the subjective patient surveys.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Double-Blinded Randomized Prospective Trial of Intranasal Capsaicin Treatment for Non-Allergic Irritant Rhinitis
Study Start Date : October 2014
Actual Primary Completion Date : August 2, 2019
Actual Study Completion Date : August 2, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Capsaicin

Arm Intervention/treatment
Experimental: intranasal capsaicin
The capsaicin solution will be prepared by using the formula previously reported by Van Rijswijk et al; (0.1mmol/l) diluted in ethanol and 0.9% normal saline (19). Using the mucosal atomizer device (MAD), 0.8 milliliters (mL) will be delivered to each nasal cavity for a total of 24.4 ug per nasal cavity. 5 consecutive applications of capsaicin or placebo will be administered intranasally, with 1 hour between each application.
Drug: Capsaicin
Other Name: intranasal capsaicin

Placebo Comparator: Vehicle solution
100 μL of 1% ethanol in 0.9% saline solution. 5 consecutive applications of capsaicin or placebo will be administered intranasally, with 1 hour between each application.
Drug: Placebo
Other Name: 1% ethanol in 9% saline




Primary Outcome Measures :
  1. Change in Total Symptom Score [ Time Frame: baseline and 4 weeks ]
    The Total Symptom Score (TSS) uses a visual analog scale (VAS) to assess typical nasal symptoms of non-allergic rhinitis (NAR), including sneezing, nasal irritation, nasal obstruction, and nasal congestion. The TSS is based on a commonly used rhinitis rating system recommended by the FDA for clinical trial studies on non-allergic rhinitis. 4 symptoms (sneezing, nasal irritation, nasal obstruction, and nasal congestion) are rated on a VAS ranging from 0 (none, no distress) to 10 (agonizing, unbearable distress). The TSS total score is the sum of the VAS score for each of the 4 symptoms, with the TSS total score ranging from 0 (none, no distress) to 40 (agonizing, unbearable distress).

  2. Change in Total Symptom Score [ Time Frame: baseline and 12 weeks ]
    The Total Symptom Score (TSS) uses a visual analog scale (VAS) to assess typical nasal symptoms of non-allergic rhinitis (NAR), including sneezing, nasal irritation, nasal obstruction, and nasal congestion. The TSS is based on a commonly used rhinitis rating system recommended by the FDA for clinical trial studies on non-allergic rhinitis. 4 symptoms (sneezing, nasal irritation, nasal obstruction, and nasal congestion) are rated on a VAS ranging from 0 (none, no distress) to 10 (agonizing, unbearable distress). The TSS total score is the sum of the VAS score for each of the 4 symptoms, with the TSS total score ranging from 0 (none, no distress) to 40 (agonizing, unbearable distress).

  3. Change in Nasal Blood Flow as Indicated by Change in Maximal Optical Density Assessed by Optical Rhinometry [ Time Frame: baseline and 4 weeks ]
    Optical rhinometry provides continuous measurement of blood flow in nasal vessels (via optical density measurements), which serves as an indirect assessment of nasal congestion. A greater decrease in optical density (OD) from baseline indicates less nasal blood flow and decreased congestion relative to baseline.

  4. Change in Nasal Blood Flow as Indicated by Change in Maximal Optical Density Assessed by Optical Rhinometry [ Time Frame: baseline and 12 weeks ]
    Optical rhinometry provides continuous measurement of blood flow in nasal vessels (via optical density measurements), which serves as an indirect assessment of nasal congestion. A greater decrease in optical density (OD) from baseline indicates less nasal blood flow and decreased congestion relative to baseline.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Non-allergic irritant rhinitis (NAIR) patients as defined by history (symptoms of nasal congestion, rhinorrhea, nasal itching or sneezing upon exposure to nasal irritants)
  • Patients with positive optical rhinometer (ORM) response with intranasal challenge with 0.5 millimolar (mM) capsaicin as described by Lambert et al 2012
  • Confirmed negative skin prick test to common allergens (which rules out allergic rhinitis)

Exclusion Criteria:

  • History of sinonasal surgery
  • Chronic rhinosinusitis
  • Inflammatory or granulomatous diseases
  • Asthma
  • Allergic rhinitis
  • Immunocompromised state
  • Radiation to the head and neck
  • Intranasal steroid use >4 wks
  • Intranasal or systemic antihistamine x 3 days
  • Intranasal or systemic decongestants x 3 days

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): NCT02493257


Locations
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United States, Texas
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
American Academy of Otolaryngic Allergy
Investigators
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Principal Investigator: Amber U Luong, MD, PhD The University of Texas Health Science Center, Houston
  Study Documents (Full-Text)

Documents provided by Denna Awni Zebda, The University of Texas Health Science Center, Houston:
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Responsible Party: Denna Awni Zebda, Associate Professor, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT02493257    
Other Study ID Numbers: HSC-MS-14-0173
First Posted: July 9, 2015    Key Record Dates
Results First Posted: August 17, 2020
Last Update Posted: August 17, 2020
Last Verified: July 2020
Keywords provided by Denna Awni Zebda, The University of Texas Health Science Center, Houston:
nonallergic irritant rhinitis
nasal congestion
rhinorrhea
Additional relevant MeSH terms:
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Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Ethanol
Capsaicin
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Antipruritics
Dermatologic Agents
Sensory System Agents
Peripheral Nervous System Agents