Demonstration of a Decongestant Effect of "Coldamaris Akut" Compared to Saline Nasal Spray.

NCT04532762 | Completed

• 1 other identifier: COA_19_03
• 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. Coldamaris akut nasal spray is a Carragelose® containing hyperosmolar solution that is indicated for supportive treatment in case of blocked nose due to rhinitis of any kind. Carragelose® is a sulfated polymer from red seaweed also widely used in the food industry and has GRAS status (FDA). The increased osmolality is based on the addition of sorbitol. This clinical study has the aim to show that Coldamaris akut has a mild decongestant effect. This will be a prospective, controlled, double-blinded randomized two-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 Coldamaris Akut and Coldamaris sine will be evaluated. The objective of the trial is to demonstrate a decongestant effect on the nasal mucosa of patients treated with Coldamaris akut nasal spray compared to subjects treated with Coldamaris sine nasal spray in grass pollen induced rhinitis/rhinoconjunctivitis. The evaluation will be based on the assessment of nasal congestion symptom during grass pollen challenge performed in the Vienna Challenge Chamber (environmental exposure chamber). Secondary objective of the trial is to demonstrate the clinical performance of Coldamaris akut nasal spray on nasal symptoms compared to subjects treated with saline nasal spray.

Conditions

Allergic Rhinitis; Allergic Rhinoconjunctivitis

Keywords

Allergic Rhinoconjunctivitis; Allergic Rhinitis; Coldamaris akut; Vienna Challenge Chamber; Nasal Congestion Symptom; Carrageenan; Carragelose; Iota-carrageenan

Outcome Measures

Primary Outcomes (1)

• Nasal Congestion Symptom Score (NCSS)

  calculated as the baseline adjusted mean of NCSS measured every 15 minutes during the grass pollen allergen exposure challenge from time-point 0 to 6 hours. The NCSS is scored on a 4-point scale from 0-3 with "0"= none "1"=mild "2"=moderate "3"=severe

  0-6 hourse of allergen exposure challenge

Secondary Outcomes (5)

• Nasal airflow

  0-6 hourse of allergen exposure challenge

• Total nasal symptom score (TNSS)

  0-6 hourse of allergen exposure challenge

• Total ocular symptom score (TOSS)

  0-3 hourse of allergen exposure challenge

• Total asthma symptom score (TASS)

  0-3 hourse of allergen exposure challenge

• Nasal secretion

  0-6 hourse of allergen exposure challenge

Study Arms (2)

Coldamaris akut

EXPERIMENTAL

One puff (140µl) into each nostril

Device: nasal spray

Placebo

PLACEBO COMPARATOR

One puff (140µl) into each nostril

Device: nasal spray

Interventions

nasal spray DEVICE

Application of a nasal spray

Coldamaris akut; Placebo

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) with the necessity to score at least "moderate = 2" for the single symptom "nasal congestion" 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 complete questionnaires and diaries.

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
• Symptoms of or treatment for upper respiratory tract infection, acute sinusitis, acute otitis media or other
• relevant infectious process at randomisation
• 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

Sponsors & Collaborators

• Marinomed Biotech AG: lead

Study Sites (1)

Vienna Challenge Chamber

Vienna, 1140, Austria

Location

Related Publications (1)

• Unger-Manhart N, Morokutti-Kurz M, Zieglmayer P, Russo A, Siegl C, Konig-Schuster M, Koller C, Graf P, Graf C, Lemell P, Savli M, Zieglmayer R, Dellago H, Prieschl-Grassauer E. Decongestant Effect of "Coldamaris Akut", a Carrageenan- and Sorbitol-Containing Nasal Spray in Seasonal Allergic Rhinitis. Int J Gen Med. 2024 Nov 8;17:5105-5121. doi: 10.2147/IJGM.S476707. eCollection 2024.

  PMID: 39534593 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: This is a prospective, placebo-controlled, double-blinded randomized two-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 Coldamaris akut nasal spray will be evaluated compared to Coldamaris sine 0.5% nasal spray.

Study Record Dates

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

Record last verified: 2020-08

Locations

AU (1)