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Rhinitis, Allergic, Seasonal clinical trials

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NCT ID: NCT03861559 Completed - Clinical trials for Rhinitis, Allergic, Seasonal

Onset of Action of Mometasone Furoate (MK-0887/SCH 032088) Nasal Spray Compared With Placebo in Seasonal Allergic Rhinitis (C93-184)

Start date: March 30, 1994
Phase: Phase 3
Study type: Interventional

This study investigated the onset of symptom relief following initiation of treatment with mometasone furoate (MK-0887/SCH 032088) 200 mcg administered once daily compared with placebo for 14 days.

NCT ID: NCT03855228 Completed - Rhinitis, Allergic Clinical Trials

Safety and Efficacy of Mometasone Furoate Nasal Spray With the Addition of Loratadine Versus Placebo in Participants With Seasonal Allergic Rhinitis (C94-145)

Start date: March 1, 1995
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the safety and efficacy of mometasone furoate nasal spray (MFNS) with the addition of loratadine vs MFNS alone, loratadine alone, or placebo, in the treatment of patients with seasonal allergic rhinitis.

NCT ID: NCT03855189 Completed - Clinical trials for Seasonal Allergic Rhinitis

Safety and Efficacy of Mometasone Furoate (SCH 032088) vs Beclomethasone Dipropionate or Placebo in Seasonal Allergic Rhinitis (C93-013)

Start date: August 23, 1993
Phase: Phase 3
Study type: Interventional

The objectives of this study are to determine the safety and efficacy in seasonal allergic rhinitis of a four-week course of mometasone furoate compared to beclomethasone dipropionate or placebo.

NCT ID: NCT03816800 Completed - Healthy Clinical Trials

Iron and Pollen Allergy in Women

Start date: January 28, 2019
Phase: N/A
Study type: Interventional

Iron deficiency and anemia are clearly associated with the onset of allergy and allergic diseases, whereas an improved iron status seems to prevent the onset of allergy in humans. Iron-deficiency can be absolute or functional. Functional iron-deficiency occurs during immune activation and may be reflective for the hyperactive state of atopic subjects. The investigators plan a prophylactic dietary intervention study in atopic/allergic and non-allergic individuals that transport chelated iron to immune cells. Over the course of six months, oral supplementation of placebo or whey protein-bound chelated iron will be given and 1) clinical reactivity 2) iron status and 3) changes in the microflora due to the treatment will be assessed.

NCT ID: NCT03776643 Completed - Clinical trials for With a Positive Skin Prick Test to Birch Pollen

Safety and Efficacy of Low-dose IL-2 in Birch Pollen Allergy

Rhinil-2
Start date: February 1, 2019
Phase: Phase 2
Study type: Interventional

Several studies have reported a deficit and/or a defect in regulatory T cells in allergic subjects, which can be correlated with the allergic responses, especially for respiratory allergies. Low-dose IL-2 (ld-IL2) specifically targets and activates regulatory T cells (Tregs), which are cells that regulate immune responses. Thus by stimulating Tregs, ld-IL2 would control allergic responses. This study is designed to evaluate the efficacy of ILT-101 (ld-IL-2), compared to placebo, on the nasal response assessed by Total Nasal Symptom Score (TNSS) during a controlled birch allergen exposure.

NCT ID: NCT03772405 Completed - Clinical trials for Rhinitis, Allergic, Seasonal

Effect of the Nasal Gel "Nascum®-Plus" on Allergic Symptoms

NAPO
Start date: December 12, 2018
Phase: N/A
Study type: Interventional

The aim of this study is to assess if a physical barrier, created by the nasal gel Nascum®- Plus, is able to prevent or minimize the induction of nasal symptoms during allergen challenge in the Fraunhofer Allergen Challenge Chamber (ACC). Furthermore, the effect on soluble and cellular inflammatory markers induced by the allergic reaction will be assessed. Nascum®-Plus contains no active pharmaceutical ingredient, only monographed pharmaceutical excipients.

NCT ID: NCT03755557 Completed - Allergic Rhinitis Clinical Trials

Demonstration of Equivalence and Early Onset of a Novel Anti-allergic Nasal Spray Compared to Marketed Nasal Spray

Start date: November 19, 2018
Phase: Phase 3
Study type: Interventional

Intranasal corticosteroids are accepted as safe and effective first-line therapy for allergic rhinitis, especially in treatment of persistent symptoms. Budesonide, a non-halogenic glucocorticoid, is widely used in the management of inflammatory mucosal diseases like chronic obstructive pulmonary disease, asthma and allergic rhinitis. It is a highly fat-soluble substance with low water solubility and is presented as dispersion in marketed nasal sprays, like Rhinocort aqua 64. The maximum therapeutic efficacy of Rhinocort aqua is obtained after an application period of 7 to 14 days. In Budesolv, the solubility of budesonide is considerably increased suggesting that the same therapeutic efficacy can be reached with a lower dose. Better bioavailability of the dissolved drug promise an earlier onset of therapeutic efficacy. The current trial is undertaken to demonstrate these two effects. Subjects suffering from grass pollen allergic rhinitis will be challenged with grass pollen in a challenge chamber. Allergic subjects will be treated with two actuations (50 μl) of respective study treatment into each nostril once daily for 8 days. The total daily budesonide dose will be 40 μg per subject for Budesolv 10 and 256 μg per subject for Rhinocort® aqua 64. The primary objective of the study is to show non-inferiority of Budesolv 10 to Rhinocort® aqua 64. On day 8 grass pollen allergic patients will be challenged with grass pollen over a period of 6 hours and subjective nasal symptoms (congestion, sneezing, itching, rhinorrhea) as well as objective symptoms (nasal airflow, nasal secretion) will be assessed every 15 minutes. The second objective of the trial is to demonstrate an early on-set of therapeutic efficacy of Budesolv 10 compared to Rhinocort aqua. On day 1, grass pollen allergic patients will be challenged with grass pollen allergen in the challenge chamber over a period of 6 hours. After 1 hour 45 minutes, patients will receive their first dosage of the respective nasal spray treatment. During the 6 hour grass pollen challenge, subjective and objective endpoints will be measured every 15 minutes. To eliminate an individual bias based on expectations, the effect and onset of action is also compared to the effects of a suitable placebo. The same set of study participants will receive all three interventions in three consecutive treatment periods.

NCT ID: NCT03664882 Completed - Rhinitis Seasonal Clinical Trials

Study Evaluating the Efficacy and Safety of Fexofenadine in Subjects Suffering From Seasonal Allergic Rhinitis in Presence of Pollutants

FEXPOLSAR
Start date: September 17, 2018
Phase: Phase 3
Study type: Interventional

Primary Objectives: - To demonstrate that the aggravation of seasonal allergic rhinitis symptoms in the presence of pollutants is observed using an Environmental Exposure Unit. - To evaluate the efficacy of fexofenadine hydrochloride in subjects suffering from seasonal allergic rhinitis symptoms aggravated in the presence of diesel exhaust particulates. Secondary Objective: To evaluate the safety of a single dose of fexofenadine hydrochloride 180 mg.

NCT ID: NCT03649139 Completed - Clinical trials for Seasonal Allergic Rhinitis

Effect and Underlying Immunological Mechanisms of Sublingual Immunotherapy in Allergic Rhinitis

Start date: April 1, 2017
Phase: Phase 3
Study type: Interventional

Allergic rhinitis (AR) is a common Ig-E mediated disease of nasal mucosa, 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). Allergen specific immunotherapy (AIT) is the only etiological treatment available for AR. Traditionally, AIT is divided into 2 types, subcutaneous immunotherapy (SCIT) and sublingual immunotherapy (SLIT), both of which are effective and safe alternatives. The trial is a randomized, double-blind, placebo-controlled trial. 72 eligible SAR patients, who were sensitized to sweet sagewort (artemisia annua), were enrolled into the trial, followed by either a 32-week SLIT schedule, where the maintenance dose would be reached within 5 weeks, or placebo SLIT schedule. Standardized depot preparations of sweet sagewort (artemisia annua) extract (Zhejiang Wolwo Bio-pharmaceutical Co., Ltd., China ) were administered by means of sublingual drops.

NCT ID: NCT03636919 Completed - Allergic Rhinitis Clinical Trials

Component Resolved Diagnostics (CRD) and mHealth for Pollen Allergy In Southern Europe.

IT-2020-MC
Start date: January 29, 2018
Phase:
Study type: Observational [Patient Registry]

Pollen allergic rhinitis is a very common condition whose symptomatic treatment is not always sufficient or satisfactory. The indication for allergic immunotherapy (IT) therefore often arises. The indication is based on the interrogation of the patient (chronology and severity of symptoms) and skin tests. But the interrogation, necessarily retrospective, brings often vague information and skin tests can be positive for allergens that have no clinical role (cross allergies). The objective of the project is to help the clinician in the indication of the IT, on the one hand by setting up a prospective and computerized collection of symptoms by a computer logbook accessible by the mobile phone of the patient. on the other hand by performing on the patient's serum a molecular diagnosis allow the identification of the major allergens to which the patient is sensitized. The same study will be conducted in 7 centers in southern European countries in patients aged 10 to 60 years with pollinosis. The examinations added by the research will take place during two routine visits: during a first visit, these patients will answer a standardized questionnaire, have a battery of allergological skin tests and a blood sample for molecular diagnosis. An application will then be loaded on their mobile phone and they will record their symptoms and medication during the pollen season. During a second visit, at the end of the pollen season, the allergist, in view of the data collected in the electronic notebook and the results of the molecular diagnosis will be able to prescribe a possible IT.