Clinical Research Directory

Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis_MM09-SIT-063.

The goal of this clinical trial is to learn whether EP-088\_MM09 works to treat house dust mite allergy. It will also assess the treatment's safety. EP-088\_MM09 contains modified house dust mite allergens called mannan-conjugated allergoids. The study plans to include 250 participants aged 12 to 65 years. They will have persistent, moderate to severe nasal allergy symptoms, with or without eye symptoms. Participants may also have mild or moderate allergic asthma, provided it is controlled. The main questions are: * Does the treatment lower allergy symptoms and the need for symptom-relief medicines compared with a placebo? * What medical problems or reactions occur during treatment? Researchers will assess how well the treatment works using a score combining symptoms and medication use. The main assessment will cover four weeks after the treatment course. Participants will be assigned by chance to receive either EP-088\_MM09 or a placebo. They will have an equal chance of receiving either treatment. The placebo looks like EP-088\_MM09 but contains no active ingredients. Neither participants nor study doctors will know which treatment each participant receives. Each participant will be in the study for approximately 14 to 21 months. Participants will: * Attend one or two visits before starting treatment to check whether they can take part. * Attend 12 treatment visits, approximately once a month, to receive injections under the skin. They will receive two injections at the first treatment visit and one at each later visit. * Stay at the clinic for at least 30 minutes after each injection. * Record symptoms and medication use daily during specified periods. * Complete questionnaires about their symptoms and quality of life, and provide blood samples. * Attend a final visit about one month after the last treatment visit. Participants who are also sensitive to pollen may need a second visit before starting treatment. This is needed if their first visit falls during the relevant pollen season or within one month before or after it.

Specific Immunotherapy With Mannan-Conjugated Allergoids for HDM-Allergic Rhinitis/Rhinoconjunctivitis. MM09-SIT-063.

The goal of this clinical trial is to learn whether EP-088\_MM09 works to treat house dust mite allergy. It will also assess the treatment's safety. EP-088\_MM09 contains modified house dust mite allergens called mannan-conjugated allergoids. The study plans to include 250 participants aged 12 to 65 years. They will have persistent, moderate to severe nasal allergy symptoms, with or without eye symptoms. Participants may also have mild or moderate allergic asthma, provided it is controlled. The main questions are: * Does the treatment lower allergy symptoms and the need for symptom-relief medicines compared with a placebo? * What medical problems or reactions occur during treatment? Researchers will assess how well the treatment works using a score combining symptoms and medication use. The main assessment will cover four weeks after the treatment course. Participants will be assigned by chance to receive either EP-088\_MM09 or a placebo. They will have an equal chance of receiving either treatment. The placebo looks like EP-088\_MM09 but contains no active ingredients. Neither participants nor study doctors will know which treatment each participant receives. Each participant will be in the study for approximately 14 to 21 months. Participants will: * Attend one or two visits before starting treatment to check whether they can take part. * Attend 12 treatment visits, approximately once a month, to receive injections under the skin. They will receive two injections at the first treatment visit and one at each later visit. * Stay at the clinic for at least 30 minutes after each injection. * Record symptoms and medication use daily during specified periods. * Complete questionnaires about their symptoms and quality of life, and provide blood samples. * Attend a final visit about one month after the last treatment visit. Participants who are also sensitive to pollen may need a second visit before starting treatment. This is needed if their first visit falls during the relevant pollen season or within one month before or after it.

Efficacy and Safety of Xinyi Powder in Patients With Allergic Rhinitis and the Lung Deficiency and Cold Syndrome

By observing the improvement of Xinyi Powder powder and simulated agent on the symptoms, symptom and sign scores, nasal symptom VAS scores, and quality of life of patients with allergic rhinitis due to lung deficiency and cold, the clinical efficacy of Xinyi Powder in the treatment of allergic rhinitis due to lung deficiency and cold is evaluated. It fully embodies the characteristics and advantages of traditional Chinese medicine treatment, provides new treatment methods for the clinical treatment of allergic rhinitis due to lung deficiency and cold, and provides objective basis for the development of new drugs.

Fixed Dose Combination of Desloratadine / Prednisolone in the Treatment of Moderate Severe Allergic Rhinitis in Children

Multicenter, randomized, parallel-group, double-blind, double-dummy, comparative clinical trial of the superiority of the fixed-dose combination of desloratadine 0.5 mg/mL and prednisolone 4 mg/mL from Eurofarma Laboratórios SA versus desloratadine 0.5 mg/mL in the treatment of moderate to severe persistent allergic rhinitis in children aged 6 to 12 years. ⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).

Does Batten Grafting Improve Nasal Outcomes in Septoplasty and Turbinate Reduction?

The objective of this study is to compare the effectiveness of batten grafts plus septoplasty and turbinate reduction (intervention arm) compared to septoplasty and turbinate reduction alone (control arm), both in terms of subjective and objective assessments.

Post-market Clinical Follow-up Study of an Isotonic Saline Solution for the Relief of Nasal Congestion in Infants and Toddlers

The goal of this observational post-market clinical follow-up study is to evaluate the safety and performance of the CE-marked nasal spray for the relief of nasal congestion in infants and toddlers aged 6 to 48 months at day 5 post-enrollment. Enrollment does not require establishing a medical diagnosis; eligibility is based on guardian-reported nasal congestion consistent with lay use of the device. Participants will be: * Evaluated by a healthcare professional for eligibility. * Receive treatment with the CE-marked nasal spray according to its Instructions for Use, for up to 14 days. * Have their legal guardians report symptom severity and improvement using standardized scales (Visual Analog Scale) during follow-up visits on Day 2, Day 5, and Day 14 and device usability on Day 14. This study does not include a comparison group and reflects real-world use of the device in routine pediatric care.

Free Diving Breathing Training in Allergic Rhinitis

The purpose of this study was to investigate the effects of diver-style breathing training on symptoms, pulmonary function, and respiratory muscle, in patients with allergic rhinitis.

A Research Study of House Dust Mite (HDM) SLIT-tablet for the Treatment of HDM Allergy in Chinese Participants Aged 12-65

A research study of house dust mite (HDM) SLIT-tablet for the treatment of HDM allergy in Chinese participants aged 12-65.

Efficacy and Safety of On-demand and Continuous Administration of Nasal Spray in the Treatment of Allergic Rhinitis

WHO recommend to divide AR into 4 subgroups according to the symptom frequency (intermittent or persistent) and severity (mild or moderate-to-severe). For the persistent moderate-to-severe AR subgroup, the guideline suggests to treat with intranasal corticosteroid (INS) plus antihistamines (AH1) for 2-4 weeks. If the symptom is controlled then degrade the treatment (usually with INS) and maintenance for more than 4 weeks. However, up to 70% of patients suffering from AR do not follow treatment recommendation, they stopped medication when they feel better. This behavior always leads to uncontrolled AR, which has been identified as a high-risk factor of induction and exacerbation of asthma and chronic rhinosinusitis. A recent survey showed that AR patients prefer to an on-demand treatment rather than continuous treatment. In general, poor adherence is always a considerable issue for all long-term treatments. Previous studies have shown that as dosing frequency increases, the adherence rate decreases. Thus, less medication frequency is an important factor to optimize the management of chronic diseases including AR. Intranasal AH1 can relieve AR symptoms including sneezing, rhinorrhea and nasal itching in 3 to 5 minutes, while INS can inhibit the underlying mucous allergic inflammation and is recommended as the first-line medication for moderate-to-severe AR. INS combined AH1 have shown a synergic effect on control AR inflammation and provide rapid AR symptom relief. Investigators hypothesis that the on-demand administration of INS combined AH1 can achieve similar AR control level with less dosing frequency as compared to the daily INS maintenance in controlled moderate-to-severe AR patients.

Evaluation of the Efficacy, Safety, and Tolerability of PL-14 Allergy Blocker Compared to Saline Spray in Patients With Seasonal Allergic Rhinitis

This study is designed to evaluate the efficacy, safety, and tolerability of PL-14 Allergy Blocker compared to saline spray in adults with Seasonal Allergic Rhinitis (SAR). PL-14 Allergy Blocker is a non-pharmacological, drug-free intranasal mucoadhesive hydrogel designed to form a mechanical barrier on the nasal mucosa and reduce contact between airborne allergens and the nasal lining. This is a prospective, randomized, single-blind, multi-center clinical investigation in up to 120 participants at up to 8 sites in the United States. Eligible participants with a history of seasonal allergic rhinitis will be randomized in a 1:1 ratio to receive either PL-14 Allergy Blocker or Ayr® Saline Nasal Mist for up to 30 days. The study will evaluate the effect of PL-14 Allergy Blocker on nasal allergy symptoms, quality of life, rescue medication use, and symptom-free days. Safety and local tolerability assessments will also be performed throughout this study period.

Periostin Levels in Children With Adenoid Hypertrophy

This prospective observational study evaluated serum and tissue periostin levels in children with adenoid hypertrophy. Children with grade 3-4 adenoid hypertrophy who were scheduled for adenoidectomy were compared with children with grade 1 adenoid hypertrophy without symptoms attributable to adenoid enlargement. Serum periostin levels were compared between the two groups. In the adenoidectomy group, periostin levels in adenoid tissue were also compared with paired samples of normal nasopharyngeal mucosa obtained from the same patients. The study aimed to investigate whether periostin may be associated with the development of adenoid hypertrophy and to explore its potential role in local tissue remodeling.

Sphenopalatine Ganglion Acupuncture for Allergic Rhinitis

Allergic rhinitis can cause sneezing, a runny or blocked nose, and nasal itching, which may affect daily activities and quality of life. Nasal corticosteroid sprays are commonly used to control these symptoms, but some people may still have bothersome symptoms. The purpose of this study is to find out whether adding sphenopalatine ganglion acupuncture to mometasone furoate nasal spray can improve allergic rhinitis symptoms more than using the nasal spray alone, and to evaluate the safety of this treatment. Adults with moderate-to-severe perennial allergic rhinitis will be randomly assigned to one of two treatment groups. Both groups will use mometasone furoate nasal spray for 4 weeks. Participants in one group will also receive sphenopalatine ganglion acupuncture twice a week for 4 weeks. Researchers will compare changes in nasal symptoms, quality of life, use of rescue medication, clinical examination findings, and adverse events between the two groups. Participants will also be followed after treatment to assess whether the treatment effects are maintained.

Safety and Performance Assessment of the Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils in Patients With Acute Rhinitis Associated With Nasal Obstruction: "DEVALPO"

The purpose of this pre-market clinical investigation is to assess the safety and the performance of decongestant seawater spray pocket valve enriched with essential oils by Gilbert Laboratories. The study will evaluate the results of acute rhinitis associated with nasal obstruction using the decongestant seawaterspray pocket valve enriched with essential oils over a 8 day period.

Performance and Safety Assessment of the Mechanical Decongestant Seawater Spray Enriched With Essential Oils From Laboratoires Gilbert in Patient With Acute Rhinitis Associated With Nasal Obstruction

The purpose of this post-market clinical investigation is to assess the performance and the safety of the mechanical decongestant seawater spray enriched with essential oils from Laboratoires Gilbert. The study will evaluate the results of the spray on the acute rhinitis with nasal obstruction over a 7 days period.

AI-Guided Ultrasound Needling of Xinwu Point for Allergic Rhinitis

This study evaluated a new way to perform acupuncture at a deep point called the Xinwu point (sphenopalatine ganglion) for allergic rhinitis (hay fever-like nasal allergy). The point is hard to reach with the usual blind needling method. Artificial intelligence (AI) with real-time ultrasound images was used to help the acupuncturist see nearby structures and guide the needle. Sixty adults were randomly assigned to AI-guided needling or usual blind needling. Both groups received the same acupuncture schedule: both sides of the face, once a week, for six sessions. The primary aim was to measure how accurately the needle reached the target. Side effects, nasal symptom scores, overall improvement, and how acceptable participants found the procedure were also recorded.

Effect of AI(Artificial Intelligence)-Based Storytelling Video on Anxiety and Fear During Skin Prick Test in Children

This study evaluates the effectiveness of an AI-generated therapeutic storytelling video on pre-procedural anxiety and fear levels in children aged 4 to 10 years undergoing their first Skin Prick Test (SPT). The study aims to determine if watching a cognitive preparation video at home prior to the appointment reduces anxiety compared to standard care. Participants will be randomized into two groups: an intervention group watching the AI-generated video and a control group receiving standard clinic care

Validation of an Allergic Rhinitis Control Test in Children

Allergic rhinitis is a common condition that affects adults as well as children and adolescents, often with impaired quality of life. Patients often report a poor level of satisfaction with the effectiveness of their treatment and are always looking for more drug combinations to improve their symptom. Several tools exist for assessing control of allergic rhinitis, but none has been validated in teenagers or in children. A study conducted in 2008, resulted in the validation of a self-administered control test of allergic rhinitis (ARCT) in patients from 12 years of age. We propose to adapt ARCT adult to pediatric population from 5 to 11 years old.

Study of Yupingfeng Powder Treating Allergic Rhinitis (AR)

Rhinitis is broadly defined as inflammation of the nasal mucosa. It is a common disorder that affects up to 40% of the population. Allergic rhinitis (AR) is the most common type of chronic rhinitis, affecting 10-20% of the population, and evidence suggests that the prevalence of the disorder is increasing. AR is a very common clinical disease that can occur at any age. Severe allergic rhinitis has been associated with significant impairments in quality of life, sleep and work performance. Nowadays, the main treatment for allergic rhinitis is the use of western medicine, such as steroids and antihistamines. However, many clinical studies have found that the curative effect of western medicine is often not ideal. From the perspective of Chinese medicine, this disease is resulted from the deficiency of Qi and Yang Qi in the lungs, spleen and kidneys. Therefore, according to Chinese medicine theory, tonifying lung and spleen qi is the treatment principle for AR patients. Among different Chinese herbal formulae for AR, Yupingfeng Powder is commonly used for allergic diseases and in AR patients, due to its warm nature and able to improve the functions of the lungs and spleen. Yupingfeng Powder can improve symptoms and quality of life, as well as decrease the levels of interleukin and IgE in AR patients. This study will use Yupingfeng Powder with variation to evaluate its effectiveness and safety in treating AR. Hence, a double-blind, randomized, placebo-controlled clinical trial design with strong scientific rigor will be employed in this study, and it would be able to provide robust clinical evidence on the efficacy and safety of Yupingfeng Powder with variation for AR. Recruited subjects will be randomly assigned to receive orally Yupingfeng Powder with variation or placebo twice a day for 8 weeks, with follow-up for another 8 weeks after stopping the treatment to observe the duration of efficacy. In our previous study, it is shown that Yupingfeng Powder can significantly improve the symptoms of AR, and there was no serious adverse event reported by the subjects. And in this project, we modify the design of the trial to further investigate the efficacy of Yupingfeng Powder with variation for AR patients with a larger sample size.

Threshold Concentrations for Ragweed and Birch Pollen in Seasonal Allergic Rhinitis

The ragweed Ambrosia artemisiifolia is spreading in northern Europe due to climate change. The pollen are considered highly allergenic and might trigger allergy symptoms at much lower concentrations than e.g. grass or birch pollen. This study aims to determine threshold concentrations for ragweed and birch pollen in patients with seasonal allergic rhinitis. Participants will be exposed in an allergen challenge chamber that was technically modified to maintain very low and stable pollen concentrations for several hours. The study design is adaptive, where the pollen concentrations are escalated or de-escalated based on interim analysis of resulting allergic symptoms.

Confirmatory Study on the Efficacy and Safety of the Fixed-dose Combination of Desloratadine/Betamethasone Versus Desloratadine

Phase IIIb , longitudinal, multicenter, randomized, double-blind, to evaluate efficacy and safety of the fixed-dose combination of Desloratadine 5 mg / Betamethasone 0.25 mg versus Desloratadine 5 mg monotherapy as treatment for symptoms associated with allergic rhinitis.

Comparative Real World Effectiveness of SQ Sublingual Immunotherapy (SLIT)-Tablets vs. Controls in Allergic Rhinitis and Asthma

To assess the impact of SQ SLIT-tablets (SQ Grass SLIT-tablet and SQ HDM SLIT-tablet) in Danish and Swedish allergic rhinitis (AR) patients, with or without asthma, between 2007-2020.

Evaluation of ALLERgen Specific Vaccination of DOG Allergic Patients in Swedish Practice

STUDY DESIGN A single-center prospective before-and-after study evaluating the effect of Alutard SQ Dog in 40 men and women with moderate-to-severe dog allergy. Participants will serve as their own controls. STUDY OUTLINE The study will begin in the fall of 2026 and will be conducted over a one-year period. At baseline, participants will be asked to record their allergic symptoms, and assessments of lung function and nasal airflow will be performed. Blood samples will also be collected. Following the baseline assessments, participants will undergo allergen provocation by entering a facility containing dogs. After a 30-minute exposure to dogs, participants will again be asked to record their allergic symptoms and will undergo the same assessments performed at baseline. Allergen immunotherapy (AIT) with Alutard SQ Dog will then be initiated according to the standard treatment regimen and continued for one year. At the end of the treatment period, the same provocation procedure and assessments will be repeated. Participants will enter a facility containing dogs, followed by symptom recording and evaluation of lung function, nasal airflow, and relevant laboratory parameters.

Observational Study of RHINOSEDAL in Acute Nasal Obstruction

This prospective, multicenter, national, observational, non-interventional post-market clinical follow-up study evaluates the performance and safety of RHINOSEDAL in children and adults presenting with acute nasal obstruction associated with common cold, allergic or non-allergic rhinitis, or rhinosinusitis. Patients prescribed RHINOSEDAL in routine care will be followed for 6 ±1 days using patient-reported outcome measures including the NOSE score.

The Efficacy Of Rhinophototherapy Compared To Intranasal Corticosteroids On The Nasal Mucosa

The aim of this study to compare the efficacy of Rhinophototherapy to Intranasal Corticosteroids on the the nasal mucosa of allergic rhinitis patients. The main question to answer is: Does intranasal phototherapy reduce inflammation in the tissue biopsy of the inferior turbinate mucosa compared to intranasal steroids? The hypothesis for this study is Intranasal phototherapy will reduce mucosal inflammation without mucosal damage and is comparable to intranasal steroids in allergic rhinitis patients