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Rhinitis clinical trials

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NCT ID: NCT02446613 Completed - Asthma and Rhinitis Clinical Trials

Follow-up Study to Investigate the Effect of GSK2245035 on Nasal Allergic Reactivity in Subjects Completing Treatment in Study TL7116958

Start date: June 22, 2015
Phase: Phase 2
Study type: Interventional

This study will evaluate the duration of effect of GSK2245035 on allergic reactivity by repeating a nasal allergen challenge (NAC) approximately one year after treatment in subjects from TL7116958. This is a single centre, single period study in subjects with respiratory allergy/allergies who completed the study TL7116958 in 2014 to investigate the long term effect of previous treatment with GSK2245035 compared with placebo on total nasal symptoms elicited by nasal allergen challenge. Subjects and staff will remain blinded to the treatment received in the TL7116958 study (GSK2245035 or placebo). The study will consist of a screening visit to assess eligibility criteria, a study period consisting of a single visit when the nasal allergen challenge will be performed, and follow up by phone or a clinic visit at the discretion of the investigator 4-7 days following the allergen challenge. Eligible subjects will participate in this study for approximately70 days total from screening to follow up.

NCT ID: NCT02443805 Completed - Clinical trials for Rhinitis, Allergic, Perennial

Efficacy & Safety of STG320 Sublingual Tablets of HDM Allergen Extracts in Adults and Adolescents With HDM-associated AR

Start date: September 29, 2015
Phase: Phase 3
Study type: Interventional

The objective of this study was to assess the efficacy and safety of 12 months of treatment with 300 IR of STG320 sublingual tablets compared with placebo in adults and adolescents with HDM-associated allergic rhinitis.

NCT ID: NCT02437786 Completed - Clinical trials for Allergic Rhinoconjunctivitis

Molecular and Cellular Mechanism in Rhinitis Allergic Patients Treated With GRAZAX®

GT-20
Start date: September 2009
Phase: Phase 4
Study type: Interventional

The specific clinical trial is a part in which ALK- Abelló will directly work to explore human immunological mechanisms of SIT (observed after GRAZAX treatment).

NCT ID: NCT02424539 Completed - Rhinitis, Allergic Clinical Trials

A Study to Compare the Efficacy and Safety of Fluticasone Furoate Nasal Sprays (FFNS) 55 Microgram (mcg) and 110 mcg in Chinese Pediatric Subjects With Allergic Rhinitis (AR)

Start date: September 30, 2015
Phase: Phase 4
Study type: Interventional

This Phase IV interventional study is a multi-center, randomized, double-blind, placebo-controlled parallel study to evaluate the efficacy and safety of FFNS110 mcg and 55 mcg once daily versus vehicle placebo aqueous nasal spray in chinese pediatric subjects ages 2 to 12 years with AR. This study comprises screening and run-in period (4 to14 days), double-blind treatment period (28 days) and follows up period (3 to7 days). Subjects entering the study will participate for maximum of 50 days, including five clinical visits and a follow-up contact. The study is planned to enroll approximately 360 subjects.

NCT ID: NCT02423707 Completed - Allergic Rhinitis Clinical Trials

Safety and Efficacy Study of Intralymphatic Allergen-specific Immunotherapy

Start date: August 2010
Phase: Phase 2/Phase 3
Study type: Interventional

Allergen-specific immunotherapy (ASIT) is commonly used to treat patients with allergic rhino-conjunctivitis and asthma, and it is the only proven treatment that affects the long-term development of allergic rhinitis and asthma. The current treatment regime of ASIT requires numerous subcutaneous allergen injections and takes several years to complete. Hence, there is a need to develop more convenient protocols for induction of allergen tolerance. Emerging evidence suggest that by targeting of antigen presenting cells within the lymph nodes the immunogenicity of the allergen can be enhanced and the number of injections can be reduced. The purpose of this study is to evaluate whether intralymphatic administration of ASIT is a safe and effective treatment for patients with pollen-induced allergic rhinitis. The long term goal is to provide a base for a more efficient administration of ASIT, which will reduce both the dose necessary and the number of clinic visits associated with the conventional subcutaneous ASIT. The investigators will make an attempt to reproduce the results of a recent human study of intralymphatic ASIT (clinicaltrials.gov; NCT00470457) in a Swedish clinical setting. The first part of the study is completed and published (PMID: 23374268)

NCT ID: NCT02409563 Completed - Allergic Rhinitis Clinical Trials

Nasal Budesonide Efficacy on Nasal FeNO in Children With Allergic Rhinitis

Start date: January 2014
Phase: Phase 4
Study type: Interventional

In clinical trials for treatment of allergic rhinitis a significant reduction of the total symptom score compared to baseline has been demonstrated by using nasal budesonide.Previous results in adults show that the assessment and monitoring del nasal fractional exhaled nitric oxide (nFeNO) is useful in controlling inflammation of nasal allergic rhinitis. Primary objective of this study is to evaluate efficacy of nasal budesonide (aqueous solution) on the nasal inflammation marker (nFeNO). Secondary outcomes are the evaluation of: changes in total nasal symptom score (Total Symptom Score, T5SS), changes in cell counts in nasal lavage (LN) and the changes reported sleep quality (Pittsburgh Sleep Quality Index, PSQI).

NCT ID: NCT02409550 Completed - Asthma Clinical Trials

CARATKids: Italian Validation of Asthma and Allergic Rhinitis Control Test in Children

Start date: April 2015
Phase: N/A
Study type: Observational

This project is an observational study for the Italian language validation of the CARATKids questionnaire investigating the asthma and coexisting allergic rhinitis control in children. 113 patients with concomitant asthma and allergic rhinitis followed up from at least 3 months will be enrolled for the validation process at outpatient clinic of Pediatric Allergology & Pulmonology (PAP) of Respiratory Disease Research Center (RDRC) within the Institute of Biomedicine and Molecular Immunology (IBIM) of the National Research Council (CNR) of Palermo (RDRC-IBIM CNR), Italy. The study will be completed in two medical examination, within 3-6 weeks of each other. CARATKids questionnaire, VAS (Visual Analogic Scale) and C-ACT (Children Asthma Control Test) will be filled by each patient. The main outcome is the Italian language validation of the CARATKids questionnaire investigating the coexisting asthma and allergic rhinitis control in children.

NCT ID: NCT02402465 Recruiting - Allergic Rhinitis Clinical Trials

Evaluating Factors Involved in Dymista's Superior Clinical Efficacy to Fluticasone Propionate in the Treatment of Seasonal Allergic Rhinitis

Start date: February 2015
Phase: Phase 4
Study type: Interventional

Dymista, a combined product containing the antihistamine azelastine and the intranasal steroid fluticasone, provides superior clinical efficacy to both fluticasone propionate and azelastine hydrochloride in the treatment of seasonal allergic rhinitis. The superiority of efficacy not only occurs at the initiation of treatment, but persists for its duration. The mechanism underlying the superior efficacy of Dymista is not known. This trial focuses on examining the effects of Dymista on the dynamics of the allergic response in man using nasal provocation with antigen. The investigators will study the relationship between symptoms, physiology, cells and mediators.

NCT ID: NCT02401191 Completed - Rhinitis Allergic Clinical Trials

A Study Assessing the Safety and Effectiveness of FEX60/PE10 Fixed Combination Tablet in Patients With Allergic Rhinitis

Start date: March 2015
Phase: Phase 3
Study type: Interventional

Primary Objective: To assess the safety of twice-daily fexofenadine 60 mg/phenylephrine 10 mg (FEX60/PE10) combination tablet in patients with allergic rhinitis. Secondary Objective: To evaluate the effectiveness of a twice-daily FEX60/PE10 combination tablet on nasal symptoms (sneezing, rhinorrhea, and nasal congestion), and daily activity impairment.

NCT ID: NCT02397915 Completed - Clinical trials for Rhinitis, Allergic, Perennial and Seasonal

Patient Preference Study of Fluticasone Furoate and Mometasone Furoate Nasal Sprays

Start date: March 26, 2015
Phase: Phase 4
Study type: Interventional

The purpose of this study is to provide information on whether subjects with allergic rhinitis (AR) prefer the administration of fluticasone furoate (FF) nasal spray or mometasone furoate (MF) nasal spray based on how the products feel to the subjects when administered. This Phase IV interventional study is a multi-center, randomized, double-blind, single-dose, cross-over subject preference study to evaluate and compare patient preference for FF [(total dose of 110 microgram (mcg)] and MF (total dose of 200 mcg) nasal sprays in subjects with allergic rhinitis. These two commonly used nasal sprays use different actuation systems (FF nasal spray is side-actuated; MF nasal spray is top-actuated) and this study will evaluate whether this difference is reflected in the patient-assessed attributes of the two nasal sprays. The attributes or properties which are being assessed by the subjects for these nasal sprays include smell, taste & aftertaste, drip down the throat, run out of the nose, urge to sneeze, and irritation. The single-day study per subject comprises screening and all treatments and procedures. Eligible subjects will be randomized 1:1 to a cross-over treatment schedule so that all subjects receive both products. One group of subjects will have two sprays of FF administered in each nostril whilst a second group will have two sprays of MF administered into each nostril. At 30 (± 5) minutes after the first study medication treatment, the two groups will switch. The first group will then have two sprays of MF administered into each nostril and the second group will then have two sprays of FF administered into each nostril. After each treatment the subject will complete two sets of attributes questionnaires ('immediate' and 'delayed'). A subject-rated 'immediate' attributes questionnaire will be completed immediately following each treatment and a subject-rated 'delayed' attributes questionnaire will be completed approximately 2 minutes after each treatment. Upon completion of the second set of these two attributes questionnaires (immediate and delayed), a preference questionnaire will be completed by the subject. In the preference questionnaire, the subject states their preferred treatment, if any, for each of the product attributes, and finally states their overall preferred treatment, if any. There will be follow-up contact with the subject 24 (± 4) and 96 (± 4) hours after administration of the last treatment. The study is planned to enroll about 300 subjects.