Advertisement

Topics

Non-inferiority, Open-label, Multicenter and Randomized Clinical Trial About the Treatment of Mild to Moderate Persistent Allergic Rhinitis

2014-08-27 03:17:39 | BioPortfolio

Summary

To assess the efficacy of the study product Noex in the treatment of allergic rhinitis by means of the Nasal Index Score (NIS) after 4 weeks of treatment with the drug.

Description

Primary objective: To assess the efficacy of the study product Noex in the treatment of allergic rhinitis by means of the Nasal Index Score (NIS) after 4 weeks of treatment with the drug.

Secondary objectives: To determine the total NIS scale score after 12 weeks of treatment and the scores of the same scale individually for the symptoms of nasal obstruction, coryza, sneezing and nasal pruritus after 4 and 12 weeks of treatment, as well as to assess the safety of the study product according to the presence of adverse events.

Some eligibility criteria:

- NIS scale score > 4 points at the randomization visit

- Patients with persistent mild to moderate AR, according to the ARIA criteria with indication for use budesonide;

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Allergic Rhinitis

Intervention

Noex, Budecort Aqua

Location

IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada
São Paulo
Brazil

Status

Recruiting

Source

Eurofarma Laboratorios Ltda

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:17:39-0400

Clinical Trials [618 Associated Clinical Trials listed on BioPortfolio]

Clinical Study, Non Inferiority Between Noex® 32µg Versus Budecort Aqua® 32µg in Treatment of Alergic Rhinitis

This study is to evaluate non inferiority of Eurofarma budesonide nasal spary x referral Astrazeneca budesonide. Half patients will receive Eurofarma medication and half patients will rece...

Clinical Study, Non Inferiority Between Noex® 50µg Versus Busonid® 50µg in Treatment of Allergic Rhinitis

This study is to evaluate non inferiority of Eurofarma budesonide nasal spray x referral Astrazeneca budesonide. Half patients will receive Eurofarma medication and half patients will rece...

Compare CE-Budesonide Nasal Solution & Rhinocort Aqua in an EEC Study of AR

The primary objective of this study was to compare the relative efficacy of Budesonide administered via Captisol-Enabled Budesonide nasal solution and Rhinocort Aqua in patients with seaso...

Compare Captisol-Enabled (CE) Budesonide + Azelastine Nasal Solution and Rhinocort Aqua + Astelin in an Environmental Exposure Chamber (EEC) Study of Allergic Rhinitis

The primary objective of this study was to compare Placebo to Captisol-Enabled Budesonide + Azelastine in a single spray and two separate sprays (Budesonide + Azelastine) in patients with ...

Study In Adults And Adolescents With Seasonal Allergic Rhinitis

Compare the efficacy and safety of an investigational nasal spray compared with placebo nasal spray in the treatment of seasonal allergic rhinitis. Allergic rhinitis is an inflammatory dis...

PubMed Articles [620 Associated PubMed Articles listed on BioPortfolio]

The Allergic Rhinitis Control Test questionnaire is valuable in guiding step-down pharmacotherapy treatment of allergic rhinitis.

Allergic Rhinitis Control Test(ARCT) has been validated in allergic rhinitis(AR) step-up pharmacotherapy management approach.

Allergic rhinitis: the modern aspects of therapy.

The main objectives of the present article were to systematize the modern views of the causes and risk factors of allergic rhinitis, to clarify the manner of its development, to define the leading eti...

Pattern of allergic rhinitis among children in Ekiti, Nigeria.

Allergic rhinitis is a chronic and recurrent nasal condition. It is often neglected in children with late presentation. This study aimed at determining the prevalence, sociodemographic features, comor...

Hypergravity enhances the therapeutic effect of dexamethasone in allergic asthma and rhinitis animal model.

We investigated whether the therapeutic effects of dexamethasone for allergic asthma and rhinitis were enhanced in mice when exposed to hypergravity. Forty mice were divided into 5 groups (n = 8/group...

The association of nasal patency with small airway resistance in children with allergic and nonallergic rhinitis.

Allergic rhinitis (AR) is immunologically and morphologically related to disorders in the lower airway. We investigated the relationship between the anatomy of the intranasal cavity and small airway r...

Medical and Biotech [MESH] Definitions

Allergic rhinitis that occurs at the same time every year. It is characterized by acute CONJUNCTIVITIS with lacrimation and ITCHING, and regarded as an allergic condition triggered by specific ALLERGENS.

A group of symptoms that are two- to three-fold more common in those who work in large, energy-efficient buildings, associated with an increased frequency of headaches, lethargy, and dry skin. Clinical manifestations include hypersensitivity pneumonitis (ALVEOLITIS, EXTRINSIC ALLERGIC); allergic rhinitis (RHINITIS, ALLERGIC, PERENNIAL); ASTHMA; infections, skin eruptions, and mucous membrane irritation syndromes. Current usage tends to be less restrictive with regard to the type of building and delineation of complaints. (From Segen, Dictionary of Modern Medicine, 1992)

A form of non-allergic rhinitis that is characterized by nasal congestion and posterior pharyngeal drainage.

A long-acting, non-sedative antihistaminic used in the treatment of seasonal allergic rhinitis, asthma, allergic conjunctivitis, and chronic idiopathic urticaria. The drug is well tolerated and has no anticholinergic side effects.

Antigens from the house dust mites (DERMATOPHAGOIDES), mainly D. farinae and D. pteronyssinus. They are proteins, found in mite feces or mite extracts, that can cause ASTHMA and other allergic diseases such as perennial rhinitis (RHINITIS, ALLERGIC, PERENNIAL) and atopic dermatitis (DERMATITIS, ATOPIC). More than 11 groups of Dermatophagoides ALLERGENS have been defined. Group I allergens, such as Der f I and Der p I from the above two species, are among the strongest mite immunogens in humans.

More From BioPortfolio on "Non-inferiority, Open-label, Multicenter and Randomized Clinical Trial About the Treatment of Mild to Moderate Persistent Allergic Rhinitis"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Allergies
The term allergy is used to describe a response, within the body, to a substance, which is not necessarily harmful in itself, but results in an immune response and a reaction that causes symptoms and disease in a predisposed person, which in turn can cau...

Drug Discovery
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...

Pharmacy
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...


Searches Linking to this Trial