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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%.)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.1mM | Active Comparator |
| |
| 0.01mM | Experimental |
| |
| 0.001mM | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capsaicin | Drug | via nasal spray |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Visual Analogue Scale for Major Nasal Symptoms | 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 | Baseline and week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Visual Analogue Scale for Individual Nasal Symptoms | 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 | Baseline, week 4 |
| Therapeutic Response in All Treatment Regimes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Hellings, Prof. Dr. | UZ Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ORL | Leuven | Vlaams-Brabant | 3000 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32439432 | Derived | Van Gerven L, Steelant B, Cools L, Callebaut I, Backaert W, de Hoon J, Ampe E, Talavera K, Hellings PW. Low-dose capsaicin (0.01 mM) nasal spray is equally effective as the current standard treatment for idiopathic rhinitis: A randomized, double-blind, placebo-controlled trial. J Allergy Clin Immunol. 2021 Jan;147(1):397-400.e4. doi: 10.1016/j.jaci.2020.04.054. Epub 2020 May 19. No abstract available. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 0,1mM | Capsaicin: via nasal spray |
| FG001 | 0,01mM | Capsaicin: via nasal spray |
| FG002 | 0.001mM | Capsaicin: via nasal spray |
| FG003 | Placebo | placebo: via nasal spray |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 0,1mM | Capsaicin: via nasal spray |
| BG001 | 0,01mM | Capsaicin: via nasal spray |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Visual Analogue Scale for Major Nasal Symptoms | 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 | Posted | Mean | Standard Deviation | score on a scale | Baseline and week 4 |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 0,1mM | Capsaicin: via nasal spray | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. Hellings | UZ Leuven | 016336340 | nkogh@uzleuven.be |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 9, 2015 | Apr 7, 2021 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D003139 | Common Cold |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D002211 | Capsaicin |
| ID | Term |
|---|---|
| D053284 | Polyunsaturated Alkamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000475 | Alkenes |
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| placebo |
| Drug |
via nasal spray |
|
Evaluation of the therapeutic response (TRE) on a scale from 1 (= no relief of symptoms) to 5 (= total relief of symptoms). |
| week 4 |
| Change of Nasal Hyperreactivity in All Treatment Modalities. | change in the number of participants with nasal hyperreactivity in all treatment modalities | baseline, week 4 |
| Number of Adverse Events in All Treatment Groups | All reported AEs were entered into the AE section so please see AE table for specifics. | week 4 |
| Number of Patients Without Improvement of Symptoms at the End of the Trial in All Treatment Modalities | week 4, 12 and 26 |
| BG002 |
| 0.001mM |
Capsaicin: via nasal spray |
| BG003 | Placebo | placebo: via nasal spray |
| BG004 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
Capsaicin: via nasal spray
| OG003 | Placebo | placebo: via nasal spray |
|
|
| Secondary | Change in Visual Analogue Scale for Individual Nasal Symptoms | 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 | Posted | Mean | Standard Deviation | score on a scale | Baseline, week 4 |
|
|
|
| Secondary | Therapeutic Response in All Treatment Regimes | Evaluation of the therapeutic response (TRE) on a scale from 1 (= no relief of symptoms) to 5 (= total relief of symptoms). | Posted | Number | percentage of patients with improvement | week 4 |
|
|
|
| Secondary | Change of Nasal Hyperreactivity in All Treatment Modalities. | change in the number of participants with nasal hyperreactivity in all treatment modalities | Posted | Number | participants | baseline, week 4 |
|
|
|
| Secondary | Number of Adverse Events in All Treatment Groups | All reported AEs were entered into the AE section so please see AE table for specifics. | All reported AEs were entered into the AE section so please see AE section for specifics. | Posted | Number | Total number of events | week 4 |
|
|
|
| Secondary | Number of Patients Without Improvement of Symptoms at the End of the Trial in All Treatment Modalities | Posted | Count of Participants | Participants | week 4, 12 and 26 |
|
|
|
| 16 |
| 0 |
| 16 |
| 10 |
| 16 |
| EG001 | 0,01mM | Capsaicin: via nasal spray | 0 | 16 | 0 | 16 | 8 | 16 |
| EG002 | 0.001mM | Capsaicin: via nasal spray | 0 | 18 | 0 | 18 | 14 | 18 |
| EG003 | Placebo | placebo: via nasal spray | 0 | 18 | 0 | 18 | 12 | 18 |
| Arthritis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Cystitis | Infections and infestations | Systematic Assessment |
|
| Ear discomfort | Ear and labyrinth disorders | Systematic Assessment |
|
| Ear Infection | Infections and infestations | Systematic Assessment |
|
| epistaxis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Eye infection | Infections and infestations | Systematic Assessment |
|
| Eye irritation | Eye disorders | Systematic Assessment |
|
| Eye Pruritus | Eye disorders | Systematic Assessment |
|
| Eyelid operation | Surgical and medical procedures | Systematic Assessment |
|
| Food poisoning | Infections and infestations | Systematic Assessment |
|
| Gastroenteritis viral | Infections and infestations | Systematic Assessment |
|
| Gastrointestinal infection | Infections and infestations | Systematic Assessment |
|
| Head discomfort | Nervous system disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Influenza | Infections and infestations | Systematic Assessment |
|
| Influenza like illness | General disorders | Systematic Assessment |
|
| Laryngitis | Infections and infestations | Systematic Assessment |
|
| Loss of consciousness | Nervous system disorders | Systematic Assessment |
|
| Malaise | General disorders | Systematic Assessment |
|
| Mite allergy | Immune system disorders | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Nasal crusting | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| nasal discomfort | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| nasopharyngitis | Infections and infestations | Systematic Assessment |
|
| oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Pneumonia | Infections and infestations | Systematic Assessment |
|
| Pyrexia | General disorders | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| Rhinitis | Infections and infestations | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Sinusitis | Infections and infestations | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Throat clearing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Tonsilitis | Infections and infestations | Systematic Assessment |
|
| Upper-airway cough syndrome | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D014777 |
| Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D006839 |
| Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D005229 | Fatty Acids, Monounsaturated |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| Male |
|
| Rhinorrhea Week 4 |
|
| week 4 |
|