Demonstration of an Anti-allergic Effect in Subjects Treated With Callergin Nasal Spray in Comparison to Untreated Subjects and Subjects Treated With Vis Alpin® Alpensalz Nasal Spray, All Suffering From Grass Pollen Induced Rhinitis/Rhinoconjunctivitis

NCT04531358 | Completed

• 1 other identifier: CAL_19_01
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Allergic rhinitis (AR) in its seasonal and perennial form is a common allergic condition. The majority of allergic rhinitis sufferers report nasal (congestion, sneezing, itching and rhinorrhea) and ocular (redness, watery eyes, itching and burning) symptoms. The polymer Carragelose® is a unique broadly active anti-viral compound for treating respiratory diseases. Carragelose® is a sulfated polymer from red seaweed also widely used in the food industry and has GRAS status (FDA). The compound has a broad spectrum of anti-viral properties. Sprayed into the nose Carragelose® creates a protective layer in the nasal cavity which could prevent allergic rhinitis symptoms as well. This anti-allergic clinical performance compared to untreated subjects and to subjects treated with Vis Alpin® Alpensalz nasal spray should be demonstrated. No clinical data in humans have been generated with Callergin so far. Callergin nasal spray is a certified Class I medical device. The use of the nasal spray is associated with a very low risk for patients. Callergin is used to moisturize nasal mucosa and to support the treatment of rhinitis of any kind. Allergic subjects could benefit from the moisturizing protective layer on the nasal mucosa, which could prevent allergen attachment to the mucosa surface. This will be a prospective, controlled, double-blinded randomized three-way cross-over single site study in adult subjects (18 to 65 years) who demonstrate a grass pollen specific Immunoglobulin E (IgE) reactivity and have a history of grass pollen induced allergic rhinitis/rhinoconjunctivitis with or without controlled asthma. In the cross-over setting two treatments, namely Callergin and Vis Alpin® Alpensalz will be evaluated compared to untreated subjects. The subjects will be treated with one puff (140 microliter) into each nostril. The primary objective of the trial is to demonstrate an anti-allergic clinical performance of Callergin nasal spray compared to untreated subjects in grass pollen induced rhinitis/rhinoconjunctivitis. The evaluation will be based on the assessment of rhinitis symptoms during grass pollen challenge performed in the Vienna Challenge Chamber (environmental exposure chamber). Secondary objective of the trial is to demonstrate an anti-allergic clinical performance of Callergin nasal spray compared to subjects treated with Vis Alpin® Alpensalz nasal spray.

Conditions

Allergic Rhinitis; Allergic Rhinoconjunctivitis

Keywords

Allergic Rhinoconjunctivitis; Allergic Rhinitis; Callergin; Vienna Challenge Chamber; Total Nasal Symptom Score; Carrageenan; Carragelose; Iota-carrageenan

Outcome Measures

Primary Outcomes (1)

• Total Nasal Symptom Score (TNSS)

  The TNSS is the sum of the four individual symptoms * nasal congestion * rhinorrhoea * itchy nose * sneezing each scored on a 4-point categorical scale from 0-3 with "0"= none "1"=mild "2"=moderate "3"=severe

  0-3 hours of grass pollen allergen exposure challenge

Secondary Outcomes (4)

• Nasal airflow

  0-3 hours of grass pollen allergen exposure challenge

• Nasal secretion

  0-3 hours of grass pollen allergen exposure challenge

• Total ocular symptom score (TOSS)

  0-3 hours of grass pollen allergen exposure challenge

• Total asthma symptom score (TASS)

  0-3 hours of grass pollen allergen exposure challenge

Study Arms (3)

Callergin

ACTIVE COMPARATOR

One puff (140 microliter) into each nostril

Device: nasal spray

Alpin Alpensalz

ACTIVE COMPARATOR

One puff (140 microliter) into each nostril

Device: nasal spray

no treatment

EXPERIMENTAL

Patients do not receive a treatment

Other: no treatment

Interventions

nasal spray DEVICE

application of nasal spray

Alpin Alpensalz; Callergin

no treatment OTHER

no treatment

no treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent obtained before any trial related procedures are performed
• Healthy male or female subjects aged 18 to 65 years
• A documented clinically relevant allergic history of moderate to severe SAR to grass pollen for the previous two years
• Subjects exhibit a moderate to severe response to approximately 1500 grass pollen grains/m3 within the first 2 hours in the Vienna Challenge Chamber, which is defined as total nasal symptom score (TNSS) of at least 6 (out of 12) using standard VCC grass pollen allergen mixture. Nasal symptom score is the sum of "nasal congestion", "rhinorrhea", "itchy nose" and "sneezing", each of which have been scored on a categorical scale from 0 to 3.
• Positive Skin Prick Test (SPT) response (wheal diameter at least 3 mm larger than diluent control) to grass pollen SPT solutions (standard Allergopharma) at screening or within the last 12 months prior to study start.
• Positive serum specific IgE against recombinant major allergen components of the used grass pollen e.g. g6 (specific CAP IgE ≥0.70 kU/L) at screening or within the last 12 months prior to study start.
• Asthma patients only if the asthma condition is mild or intermittent, and if those are not treated with steroids
• Subject has a forced expiratory volume in 1 second (FEV1) of at least 80% of predicted value (ECCS) at the screening.
• Subject is capable of understanding the study procedures and potential risks associated with the study, and voluntarily agrees to participate by giving written informed consent.
• Subject is able to adhere to dose and visit schedules.
• Subject is able to read, understand and

You may not qualify if:

• A clinical history of uncontrolled asthma within 3 months prior to screening
• Subjects with asthma requiring treatment with inhaled corticosteroids on a regular basis judged by the investigator
• Previous successful immunotherapy to grass pollen, a grass pollen allergen or a cross-reacting allergen within the past 3 years
• Ongoing treatment with any allergen-specific immunotherapy product
• Subjects with history of tuberculosis
• Symptoms of or treatment for upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infectious process at randomization
• Clinically relevant nasal polyps, medical history of paranasal sinus surgery and/or medical history of surgery of nasal turbinates judged by the investigator
• Subjects using any ophthalmic steroids during the last 30 days
• Subjects treated with nasal, inhaled or systemic steroids during the last 30 days
• History of anaphylaxis with cardiorespiratory symptoms (immunotherapy, exercise induced, food allergy, drugs or an idiopathic reaction)
• Any clinically relevant chronic disease judged by the investigator
• Systemic disease affecting the immune system judged by the investigator
• Use of an investigational drug within 30 days/5 half-lives of the drug (which ever longest) prior to screening
• History of allergy, hypersensitivity or intolerance to any ingredients of the study medication
• History of alcohol or drug abuse.

Sponsors & Collaborators

• Marinomed Biotech AG: lead

Study Sites (1)

Ordination Dr. Petra Zieglmayer Vienna Challenge Chamber

Vienna, 1140, Austria

Location

Related Publications (1)

• Unger-Manhart N, Morokutti-Kurz M, Zieglmayer PU, Lemell P, Savli M, Zieglmayer R, Prieschl-Grassauer E. Carrageenan-Containing Nasal Spray Alleviates Allergic Symptoms in Participants with Grass Pollen Allergy: A Randomized, Controlled, Crossover Clinical Trial. Int J Gen Med. 2024 Feb 3;17:419-428. doi: 10.2147/IJGM.S447359. eCollection 2024.

  PMID: 38333020 DERIVED

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Eva Prieschl-Grassauer, PhD

  CSO

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, controlled, double-blinded randomized three-way cross-over single site study In the cross-over setting two treatments, namely Callergin and Vis Alpin® Alpensalz will be evaluated compared to untreated subjects.

Study Record Dates

• First Submitted: August 21, 2020
• First Posted: August 28, 2020
• Study Start: August 4, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: February 21, 2021

Record last verified: 2020-10

Locations

AU (1)