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Rhinitis, Allergic clinical trials

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NCT ID: NCT04541004 Completed - Allergic Rhinitis Clinical Trials

Adolescent Mite Allergy Safety Evaluation

AMASE
Start date: September 23, 2020
Phase: Phase 3
Study type: Interventional

This is a 28-day clinical trial studying the safety of the house dust mite tablet in adolescents with allergic rhinitis/rhinoconjunctivitis. The purpose of this trial is to collect additional safety information about a tablet used to treat house dust mite allergies, when used to treat adolescents who have these allergies. The trial medication used is already approved to treat allergic rhinitis caused by house dust mite in adults and adolescents (12-17 years old) in several countries.

NCT ID: NCT04534452 Completed - Clinical trials for Nasal Congestion Due to Allergic Rhinitis

Study to Find Out Whether Participants With a History of Stuffy Nose Due to Allergic Reactions in the Nose Would Intend to Buy Drug Phenylephrine Hydrochloride Extended Release Tablets After Receiving it Once in This Study

Start date: May 12, 2012
Phase: Phase 3
Study type: Interventional

The researchers in this study want to find out whether participants with a history of stuffy nose due to allergic reactions in the nose would intend to buy drug Phenylephrine Hydrochloride (Phenylephrine HCl) extended release tablet (a pill is formulated so that the drug is released slowly over time) after receiving it once in this study. Phenylephrine HCl is an over-the-counter (OTC) drug (a medicine that can be bought without a prescription) used to provide temporary relief of stuffy nose caused by cold or allergies in mouth, nose and throat. Phenylephrine HCl immediate-release tablet (a pill with drug released rapidly without special rate controlling) was already approved to be used for adults and children and the recommended dose for adults and children 12 years or older is 10mg every 4 hours. Phenylephrine HCl 30mg extended release tablet used in this study is not yet approved but under development with a goal to relieve stuffy nose for every 8 hours. Researchers also want to find out if participants have any medical problems during the trial. Participants in this study will be asked to record their stuffy nose symptoms in a diary before and after drug intake. At 8 hours after drug intake, participants need to assess whether they intends to buy the drug or not and their overall satisfaction of the stuffy nose relief. At the end the participants will complete a questionnaire about their job, learning background, income and medical history of stuffy nose.

NCT ID: NCT04532762 Completed - Allergic Rhinitis Clinical Trials

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

Start date: August 4, 2020
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04532710 Completed - Allergic Rhinitis Clinical Trials

Therapeutic Effect of Tacrosolv in Patients With Allergic Rhinoconjunctivitis

Start date: August 4, 2020
Phase: Phase 2
Study type: Interventional

Allergic conjunctivitis is one of the most common comorbidities of allergic diseases, especially of allergic rhinitis. Rhinoconjunctivitis is an allergic condition of the nasal mucosa and the eyes. Conjunctivitis is triggered by hypersensitivity to certain pollens and other airborne allergens and causes several symptoms such as reddened eyes, itchy eyes and can cause watery eyes and a scratchy feeling in the eye. Tacrolimus is a well-known immunosuppressiv active substance which is hardly soluble in water. Within Tacrosolv, Tacrolimus is completely dissolves in aqueous solution. The effectiveness of Tacrosolv will be tested for treatment of allergic conjunctivitis. Allergic subjects will be treated with aqueous formulation of tacrolimus 'Tacrosolv 50 micrograms per milliliter, eye drops' for 8 days. On day 1 and day 8 allergic patients will be challenged with grass pollen for a period of 4 hours and subjective allergic symptoms will be assessed.

NCT ID: NCT04531358 Completed - Allergic Rhinitis Clinical Trials

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

Start date: August 4, 2020
Phase: N/A
Study type: Interventional

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.

NCT ID: NCT04489121 Completed - Clinical trials for Seasonal Allergic Rhinitis

The Efficacy of Preseasonal Omalizumab Treatment

Start date: July 28, 2020
Phase: N/A
Study type: Interventional

Allergic rhinitis (AR) is induced by an immunoglobulin E (IgE)-mediated reaction in the allergen-sensitized subjects, affecting 10% to 40% of the world population. AR could be divided into two kinds, perennial AR and seasonal AR (SAR). In recent years, biologics have become promising drugs for allergic diseases. The efficacy and safety of Omalizumab in treating SAR have been well proven by previous studies. However, the efficacy in preseasonal treatment for SAR has not yet been studied before.

NCT ID: NCT04479085 Completed - Allergic Rhinitis Clinical Trials

Effect of Home Environment Regulation on Symptom Control and Quality of Life in Children With Allergic Rhinitis

Start date: July 1, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to examine the effect of nursing intervention to regulate the home environment on symptom control and quality of life in children with allergic rhinitis.

NCT ID: NCT04477382 Completed - Allergic Rhinitis Clinical Trials

Impact of a Novel Immune Modulating Dietary Supplement on House Dust Mite Induced Allergic Rhinoconjunctivitis

Start date: January 6, 2020
Phase:
Study type: Observational

A validated mobile Allergen exposure chamber (AEC) is used to expose qualified study participants suffering from house dust mite (HDM) induced allergic rhinoconjunctivitis. A maximum of four individuals are exposed at a time under standardized conditions with a mixture of allergens from Dermatophagoides pteronyssinus and Dermatophagoides farinae (each 50%, faeces and body allergens; doses of 250 μg/m3 air; 21°C, and 55% relative air moisture). After the first exposure, a dietary supplement lozenge, containing beta-lactoglobulin (BLG), iron, retinoic acid, zinc and polyphenols, is taken twice daily for a period of 12 weeks, followed by the second exposure. A minimum of thirty persons are challenged with HDM allergen. After entering the chamber there is an acclimatization phase of 20 minutes with no exposure. Exposure time starts after acclimatization in the chamber and is 120 minutes at each visit. Objective parameters are recorded every 30 minutes, and subjective parameters are recorded every 10 minutes over a period of 120 minutes. During the exposure a plateau (steady-state) of total nasal symptom score with a difference from baseline is measured in all participants for each of the two exposures with HDM.

NCT ID: NCT04435990 Recruiting - Rhinoconjunctivitis Clinical Trials

Efficacy and Safety Evaluation for the Treatment of Allergy Against Mites

MM09-SIT-023
Start date: October 6, 2020
Phase: Phase 3
Study type: Interventional

A double-blinded, placebo-controlled, prospective, multicenter randomized of 2 active treatment groups, compared to 1 placebo group, for the determination of the efficacy and safety of subcutaneous immunotherapy in patients with rhinitis/rhinoconjunctivitis with mild to moderate asthma, sensitised to Dermatophagoides pteronyssinus and /or Dermatophagoides farinae.

NCT ID: NCT04389034 Completed - Allergy Clinical Trials

Influence of Specific Immunotherapy With Pollinex Quattro (Tree-/Grass Pollen) on Allergen-specific Immunoglobulin E (IgE) Levels

Start date: April 22, 2020
Phase:
Study type: Observational

Primary goal of this non-interventional study is to evaluate the change in level of allergen-specific IgE (EAST class) after allergen-specific immunotherapy with Pollinex Quattro with tree and/or grass pollen extracts and their mixtures under medial routine at adults with tree- and/or grass-medicated pollinosis.