Treatment Trials

305 Clinical Trials for Various Conditions

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ACTIVE_NOT_RECRUITING
Clinical Evaluation of Safety and Efficacy for the NEUROMARK System in Subjects with Chronic Rhinitis (PARAGON)
Description

The PARAGON Study is a prospective, single-arm, multicenter safety and efficacy study of the Neurent Medical NEUROMARK System in subjects with chronic rhinitis.

COMPLETED
Safety and Efficacy Study of the Neurent Medical NEUROMARK™ System in Subjects With Chronic Rhinitis (CLARITY)
Description

The CLARITY Study is a prospective, single-arm, multicenter safety and efficacy study of the Neurent Medical NEUROMARK System in subjects with chronic rhinitis.

COMPLETED
Safety and Efficacy Study of the Neurent Medical NEUROMARK™ System in Subjects With Chronic Rhinitis
Description

A randomized, sham-controlled, double-blind study of the NEUROMARKTM system as a treatment for chronic rhinitis

COMPLETED
Rhinitis in the Elderly: The Role of Vitamin D
Description

A study of the role of vitamin D in elderly subjects with perennial and/or nonallergic rhinitis. The hypothesis is that vitamin D supplementation will improve rhinitis symptoms and rhinitis related quality of life.

Conditions
COMPLETED
A Study Comparing Two Fluticasone Furoate Nasal Sprays in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis
Description

This study compared the safety and efficacy of a generic fluticasone furoate (Lek Pharmaceuticals) nasal spray to the reference listed drug in the treatment of seasonal allergic rhinitis. Additionally both the test and the reference formulations were tested for superiority against a placebo nasal spray.

COMPLETED
A Study Comparing the Clinical Equivalence of Two Mometasone Nasal Sprays in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis
Description

This study compared the efficacy and safety of a generic mometasone nasal spray to the reference listed drug in the treatment of seasonal allergic rhinitis. Additionally both the test and the reference formulations were tested for superiority against a placebo nasal spray.

COMPLETED
Management of Allergic Rhinitis Patients With Nasal Steroids and NeilMed® Sinus Rinse™ System With Isotonic Saline
Description

You are being asked to volunteer for a research study. You are being asked to participate in this study because you have completed at least one month of drug treatment with a nasal steroid and allergy testing and still have symptoms. This research study is sponsored by NeilMed Pharmaceuticals, Inc. The purpose of this study is to compare quality of life outcomes in patients who continue medical treatment plus the use of the NeilMed Sinus Rinse low-pressure pump with saline. Your participation in this study may help to improve the management of patients with allergic rhinitis. Allergic rhinitis is a common health problem, affecting between 10% and 40% of the world's population. Presently, antihistamines and nasal steroids are the standard treatment for allergic rhinitis. To further clarify these findings, we propose a study comparing the differences in quality of life improvements, by using a series of questionnaires, between subjects electing continued medical management and those electing medical treatment plus nasal wash. The investigators in charge of the study are Dr. Rodney J. Schlosser and Dr. Shaun A. Nguyen. Approximately 40 patients will be enrolled in this study at the Medical University of South Carolina (MUSC Hospital). You will have the choice of choosing either to receive only medical treatment or to receive medical treatment with nasal wash.

Conditions
COMPLETED
Comparison of Seasonal Allergic Rhinitis Treatment With 2 Antihistamines Used in Combination With Intranasal Corticosteroid
Description

The purpose of this study is to compare the efficacy of Olopatadine Nasal Spray with Azelastine Nasal Spray when treatments are utilized in conjunction with Fluticasone Nasal Spray for the treatment of seasonal allergic rhinitis.

COMPLETED
Evaluation of the Sensory Attributes of Olopatadine 0.6% and Azelastine 137mcg Nasal Sprays in Patients w/Allergic Rhinitis
Description

To compare patient perceptions of the sensory attributes, including taste and aftertaste, of Olopatadine relative to azelastine when administered as a single dose in patients with allergic rhinitis.

COMPLETED
The Effect of Pseudoephedrine on Rhinitis and Sleep
Description

The hypothesis is that pseudoephedrine, a sympathomimetic amine commonly used as a decongestant, will decrease nasal congestion leading to increased patency of the nose and a decrease in nighttime sleep fragmentation in individuals with year round perennial allergic rhinitis (PAR). This decrease in sleep fragmentation will reduce daytime somnolence and fatigue.

Conditions
COMPLETED
Comparison of Olopatadine 0.6% and Fluticasone Proprionate 50mcg Nasal Sprays in a Two Week Seasonal Allergic Rhinitis Trial
Description

Comparison of two nasal sprays for the treatment of seasonal allergic rhinitis

TERMINATED
Oxymetazoline Hydrochloride in Combination With Nasal Glucocorticosteroid for Perennial Allergic and Non-allergic Rhinitis in Subjects With Persistent Nasal Congestion
Description

Nasal glucocorticosteroids (GCS) are considered first-line therapy for both allergic and non-allergic rhinitis.1-3 Nasal congestion can persist despite maximum treatment with intranasal GCS. No other drugs are superior to intranasal GCS in relieving nasal congestion. For example, antihistamines are not effective in relieving congestion.1 Oral decongestants are somewhat beneficial in relieving nasal congestion but can elevate blood pressure, cause restlessness, and cause urinary retention. Oxymetazoline, however, is a potent decongestant and the addition of it to a nasal GCS should add a considerable decongestant benefit. It may also be beneficial in patients with persistent nighttime congestion despite maximum dosages of nasal GCS. Oxymetazoline is currently recommended for three days use because of the proposed risk of rhinitis medicamentosa,4 which is increased nasal congestion caused by prolonged use of nasal decongestant sprays.5-8 The term RM was coined early in the twentieth century after several case reports described patients developing rebound congestion after using first generation intranasal decongestants such as privine hydrochloride and ephedrine for prolonged periods6,7. The histopathology and mechanism of RM has been based on animal models which may not be pertinent to humans.9-13 Studies using oxymetazoline, a newer intranasal decongestant, in individuals without rhinitis have shown conflicting evidence for the development of RM.14-16 For example, normal individuals without rhinitis using oxymetazoline three times daily for four weeks did not develop RM.17 Also, it is unknown the frequency of administration and dosage of oxymetazoline it takes to induce RM or whether RM is just a return to a patient's baseline nasal congestion as present before beginning oxymetazoline. It is also unknown whether RM is more likely or only occurs with older vasoconstrictors such as privine hydrochloride and ephedrine rather than oxymetazoline. Nasal GCS reduce the amount of rebound congestion in patients with perennial allergic rhinitis who have reportedly developed RM.18 Nasal GCS decrease nasal mucosa edema, recruitment of neutrophils and mononuclear cells, cytokine production, and late-phase nasal mediators.19-21 They may offer a protective benefit from the risk of developing RM. Oxymetazoline may also decrease inferior turbinate hypertrophy thereby permitting better adsorption of the nasal GCS. Hypothesis The addition of oxymetazoline to a nasal GCS for fourteen days will decrease the amount of congestion in subjects with allergic or non-allergic rhinitis with persistent congestion despite maximum recommended dosages of a nasal GCS. It is also hypothesized that nasal GCS protect against the development of RM secondary to oxymetazoline.

UNKNOWN
Singulair Use in Non-Allergic Rhinitis Eosinophil Syndrome (NARES)
Description

The purpose of this trial is to determine if patients with NARES treated with montelukast (Singulair) will have improved nasal symptom scores and reduced nasal eosinophils.

Conditions
WITHDRAWN
Adolescent and Adult Subjects With Asthma and Seasonal Allergic Rhinitis Receiving Advair Diskus or Placebo
Description

The four respiratory drugs being researched in this study have been approved by the US Food and Drug Administration (FDA) and are currently available by prescription at your drug store. One of the drugs is for the treatment of asthma alone, one is for treatment of SAR alone, and one is for treatment of both SAR and asthma. In addition, you will also receive one asthma rescue drug (albuterol) that is to be used for any breakthrough asthma symptoms that you may experience throughout the study. The purpose of this study is to see how well your asthma and SAR are controlled when taking one of the medicine combinations

COMPLETED
Validation of Laser Doppler Flowmetry to Identify Allergic Rhinitis Patients With Pharmacogenetic Alterations in Histamine Metabolism
Description

The hypothesis to be proven is that histamine iontophoresis with measurement of microvascular blood flow by laser Doppler flowmetry can be used as a reliable marker to characterize the normal microvascular cutaneous response to histamine.

TERMINATED
Treatment of Rhinitis With Intranasal Vitamin E
Description

Many beneficial effects of vitamin E have been described, but vitamin E supplementation by mouth has not been effective in the treatment of nasal symptoms and allergic rhinitis. The investigators will evaluate the effect of vitamin E directly applied to the lining of the nose in individuals with moderate to severe rhinitis by symptom questionnaires.

Conditions
RECRUITING
Impact of Help-Seeking Behaviors on Allergic Rhinitis and Mental Health: A Longitudinal Study
Description

This study explores how help-seeking behaviors for both emotional well-being and allergies impact the management of allergic rhinitis, asthma, and mental health symptoms, including anxiety and depression. The research involves a retrospective and longitudinal analysis of patients who sought treatment for allergic rhinitis and mental health concerns. The goal is to highlight the importance of integrating mental health care into allergy treatment plans to improve overall patient outcomes.

NOT_YET_RECRUITING
Harnessing Digital Medicine to Improve Allergic Rhinitis Management in Primary Care (DMAR)
Description

This study aims to evaluate the effectiveness of digital tools in managing allergic rhinitis (AR) in primary care settings. AR is a common condition that affects many people's quality of life. The study will test whether digital tools, such as the QHSLab platform, can help patients better control their symptoms, improve adherence to treatment, and enhance overall well-being. The trial will compare two groups: one using standard care and the other using both standard care and digital tools. Participants will be monitored over 12 months, and the study will measure changes in symptom severity, treatment adherence, quality of life, and healthcare usage. The study will also gather feedback from patients and healthcare providers about their experience with the digital tools. The digital tools used in this study are designed to help patients manage their AR more effectively by providing regular symptom assessments, medication reminders, and personalized feedback based on their health data. This summary ensures the information is clear and straightforward for patients, families, and healthcare providers while maintaining compliance with IRB guidelines.

RECRUITING
A Study of RhinAer Stylus for Treating Chronic Rhinitis
Description

Post-market study to continue to evaluate the effectiveness of the RhinAer Stylus for chronic rhinitis and the effect of treatment on inflammatory biomarkers.

RECRUITING
A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)
Description

The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in adult participants with perennial allergic rhinitis. The study will last about 18 months

COMPLETED
Effects of Radiofrequency Ablation of Posterior Nasal Nerves on Inflammatory Cytokines, Peak Nasal Inspiratory Flow, and Nasal Blood Flow in Patients With Chronic Rhinitis
Description

The purpose of this study is to assess the effectiveness of radiofrequency ablation (RFA) of the posterior nasal nerve (PNN) in chronic rhinitis (CR) patients by comparing patient reflective total nasal symptom score (rTNSS) and nasal obstruction symptom evaluation (NOSE) , peak nasal inspiratory flow (PNIF) , and levels of Type 2 cytokines pre- and post-procedure.

RECRUITING
Efficacy of Azelastine and Mometasone Irrigation in Comparison to Nasal Sprays in Patients With Chronic Rhinitis
Description

The goal of this clinical trial is to determine the best combination of drugs and drug delivery routes to treat surgically naive chronic rhinitis patients. The main question it aims to answer is: Do high volume, high pressure delivery mechanisms in nasal irrigation improve the efficacy of azelastine combined with nasal steroid mometasone as compared to the standard low pressure, low volume delivery mechanisms in nasal sprays? Subjects will complete six months of one of three medication regimens: 1. Saline irrigation followed by azelastine spray and mometasone spray 2. Mometasone saline irrigation 3. Azelastine saline irrigation combined with mometasone saline irrigation.

COMPLETED
Efficacy and Safety of PQ Grass in Subjects With Seasonal Allergic Rhinitis and/or Rhinoconjunctivitis Induced by Grass Pollen
Description

The PQGrass306 (G306) clinical trial is the pivotal Phase III efficacy clinical trial of PQ Grass. The aim of the G306 pivotal clinical trial is to confirm the efficacy and safety of the optimal effective dose of PQ Grass 27600 SU. This will be determined through the measurements of the effect of PQ Grass on the symptoms of seasonal allergic rhinitis (SAR)/rhinoconjunctivitis and the use of relief medications to control these symptoms during the peak grass pollen season (GPS).

RECRUITING
The Prevalence of Local Immunoglobulin E (IgE) Elevation and Its Effect on Intranasal Capsaicin Therapy in the Non-allergic Rhinitis Population
Description

The purpose of this study to determine the therapeutic response of non-allergic rhinitis patients that have been subtyped as non-allergic rhinitis with local IgE elevation or non-allergic rhinopathy to intranasal capsaicin based on visual analog scale and optical rhinometry, to determine the prevalence of non-allergic rhinitis with local IgE elevation in this study's cohort of patients with non-allergic rhinitis identified by rhinitis history and negative skin testing for allergic rhinitis, and to determine the change, if any, in intranasal IgE levels after capsaicin treatment.

TERMINATED
A Study to Examine the Efficacy and Safety of Anti-Fel d 1 Antibodies Injections in Cat-allergic Adolescent and Adult Patients With Allergic Rhinitis Who Live With a Cat
Description

The primary objective of the study is to determine the efficacy of REGN1908-1909, as compared to placebo, to reduce allergic rhinitis/conjunctivitis symptoms and allergy rescue medication use during natural cat exposure. The Secondary Objectives are: * To assess the reduction of allergic symptoms and use of allergy rescue medications after treatment with REGN1908-1909 versus placebo, as measured by the individual components of the CSMS * To assess health-related quality of life (HRQoL) as measured by the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ\[S\]) * To determine the efficacy of REGN1908-1909, as compared to placebo, to inhibit a wheal-and-flare response to a skin prick test with cat allergen * To assess the durability of effect in allergic rhinitis and conjunctivitis symptom and medication scores after multiple doses of REGN1908-1909 compared to placebo given every 12 weeks (Q12W) * To determine the efficacy following multiple doses of REGN1908-1909 compared to placebo at inhibiting a wheal-and-flare response to a skin prick test with cat allergen * To estimate the effect of REGN1908-1909 on lung function, as compared to placebo, in patients with asthma * To determine the efficacy of REGN1908-1909 as compared to placebo to reduce asthma symptoms in patients with asthma * To assess whether there is a difference in asthma rescue medication use in patients with asthma who are treated with REGN1908-1909 compared to placebo * To assess whether there is a difference in nighttime awakenings in patients with asthma treated with REGN1908-1909 compared to placebo * To evaluate the short-term and long-term safety and tolerability of REGN1908-1909, including the incidence of hypersensitivity reactions, local injection site reactions, and asthma exacerbations * To determine systemic exposure of total (free and antigen-bound) antibodies as measured by concentration of REGN1908 and REGN1909 * To assess the immunogenicity of REGN1908 and REGN1909

ACTIVE_NOT_RECRUITING
Repurposed Use of Allergic Rhinitis and Allergic Asthma Drug to Reduce Vertigo and Hearing Loss in Meniere's Disease
Description

The purpose of this study is to evaluate a previously FDA-approved medication that is known to help with allergy symptoms to see if it can decrease symptoms in patients with Meniere's Disease.

WITHDRAWN
Chlorpheniramine Maleate Nasal Spray for Chronic Rhinitis
Description

Allergic rhinitis is defined as the symptoms of sneezing, nasal itching, airflow obstruction, and, mostly, clear nasal discharge caused by IgE-mediated reactions against inhaled allergens and involving mucosal inflammation driven by T cells (Th2) auxiliary type 2. pollens and molds, as well as allergens from perennial interiors, such as dust mites, pets, pests, and some molds. The pattern of dominant allergens depends on the geographic region and degree of urbanization, but the general prevalence of sensitization to allergens does not vary among census districts in the United States. This research proposes to study a separate antihistamine in a nasal spray. It is important to note that this antihistamine is available without prescription (OTC) and has been studied intranasal since the 1950s1

COMPLETED
Study to Assess the Efficacy of Anti-Bet v 1 Monoclonal Antibodies in Adults to Reduce Symptoms of Seasonal Allergic Rhinitis
Description

The primary objective is to assess the reduction of allergic symptoms as measured by combined symptom and medication score (CSMS) during birch pollen season after a single dose of REGN5713-5714-5715 versus placebo.

COMPLETED
Quality of Life Impact of Chronic Rhinitis Treatment With Aerin Medical Device
Description

Evaluation of long-term (2-year) quality of life and symptoms after chronic rhinitis treatment with the Aerin InSeca/RhinAer Stylus

ACTIVE_NOT_RECRUITING
A Study of RhinAer ARC Stylus for Treating Chronic Rhinitis (RELIEF)
Description

Post-market study to continue to evaluate the effectiveness of the RhinAer ARC Stylus for chronic rhinitis.