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corticosteroid therapy

Phase 1

Bronchial Asthma | Small molecule | Respiratory |Novartis AG|Last Updated: Jun 22, 2007

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment26

FDA Designations

No designations recorded

Clinical trial landscape

corticosteroid therapy · 1 trial · 1 indication

Phase 1 1
NCT00411567A Study to Assess the Efficacy of Inhaled Corticosteroid (ICS) Therapy in Moderate-Severe Bronchial AsthmaBronchial Asthma
COMPLETED26 Analytics
PHASE1COMPLETED
A Study to Assess the Efficacy of Inhaled Corticosteroid (ICS) Therapy in Moderate-Severe Bronchial Asthma
Bronchial AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in inflammatory parameters in response to a decrease in ICS compared to no change in therapy after 2 and 4 weeks

Secondary Endpoints

Parameter/combination of parameters most sensitive to the ICS reduction
Collection of relative data to assess sample size calculations for subsequent studies
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
inhaled corticosteroid therapyDRUG -
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male and/or female moderate to severe asthmatic patients, from 18-75 years of age. * Moderate to severe asthma, according to the GINA guidelines, for at least one year with no exacerbations requiring hospitalization and/or oral steroids within the previous three months. * No c...

Countries:Germany
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Frequently asked questions about corticosteroid therapy

What is corticosteroid therapy used for in bronchial asthma?

Corticosteroid therapy is an investigational small molecule being studied for the treatment of moderate to severe bronchial asthma. It is administered via inhalation and is currently in Phase 1 clinical development. The therapy is being evaluated for its efficacy in managing asthma symptoms in adult patients.

What does corticosteroid therapy target?

Corticosteroid therapy works by reducing inflammation in the airways, which is a key component of asthma pathophysiology. As a corticosteroid, it is designed to modulate the inflammatory response that contributes to bronchial constriction and asthma symptoms. This mechanism is being investigated in the context of moderate to severe bronchial asthma.

Who makes corticosteroid therapy?

Corticosteroid therapy is being developed by Novartis AG, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol NVS. Novartis is conducting clinical research to evaluate the safety and efficacy of this inhaled corticosteroid for the treatment of bronchial asthma.

What phase is corticosteroid therapy in?

Corticosteroid therapy is currently in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 1 trial has been completed, and the therapy is being evaluated for its efficacy in patients with moderate to severe bronchial asthma.

What clinical trials is corticosteroid therapy in?

Corticosteroid therapy has been studied in one clinical trial, identified as NCT00411567, titled 'A Study to Assess the Efficacy of Inhaled Corticosteroid (ICS) Therapy in Moderate-Severe Bronchial Asthma.' This Phase 1 trial was completed in Germany and enrolled 26 adult participants with bronchial asthma.

Is corticosteroid therapy the same as inhaled corticosteroid therapy?

Corticosteroid therapy is an inhaled corticosteroid (ICS) therapy, as indicated by the clinical trial title. The drug is administered via inhalation and is being studied for its efficacy in treating moderate to severe bronchial asthma. The trial specifically evaluates the efficacy of this inhaled corticosteroid formulation.