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Conventional Asthma Therapy

Phase 3

Asthma | Small molecule | Respiratory |AstraZeneca PLC|Last Updated: Aug 27, 2012

Success Probability

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Market & Valuation

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Trial Design

ACTIVE_CONTROLLED
Total Trials1
Total Enrollment241

FDA Designations

No designations recorded

Clinical trial landscape

Conventional Asthma Therapy · 1 trial · 1 indication

Phase 3 1
NCT00509028Safety and Efficacy Study of Budesonide (Pulmicort®) Turbuhaler® in Japanese Children With Bronchial AsthmaAsthma
COMPLETED241 Analytics
PHASE3COMPLETED
Safety and Efficacy Study of Budesonide (Pulmicort®) Turbuhaler® in Japanese Children With Bronchial Asthma
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Study Endpoints

Primary Endpoints

Number of Patients With Adverse Events (AEs).
54 weeks

AEs were defined as undesirable medical conditions or deteriorations of a pre-existing medical condition following/during exposure. All Serious AEs, AEs leading to withdrawal, Other relevant AE were recorded.

Secondary Endpoints

Number of Patients With Abnormal Clinical Laboratory Test Values.
54 weeks
Number of Patients With Abnormal Vital Sign Values for the Following Variables: Blood Pressure (Sitting) and Pulse Rate (Sitting), as Judged by the Investigator
54 weeks
Number of Patients With Abnormal Plasma Cortisol Values.
54 weeks
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
BUD - BudesonideEXPERIMENTALBudesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily
CONV - Conventional Asthma TherapyACTIVE_COMPARATORConventional Asthma Therapy - according to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.

Interventions

NameTypeDescription
BudesonideDRUGBudesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily
Conventional Asthma TherapyDRUGAccording to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
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Eligibility Criteria

Age Range5 Years to 15 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Patient who complete preceding the Phase III study and provide a signed written informed consent by patient's legal representative at Visit 1 or 4 weeks prior to Visit 1 of the study. A signed written informed assent should also be obtained from the patients themselves as much...

Countries:Japan
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Frequently asked questions about Conventional Asthma Therapy

What is Conventional Asthma Therapy used for?

Conventional Asthma Therapy is used for the treatment of asthma. It is being developed by AstraZeneca PLC as a small molecule therapy for respiratory conditions. The therapy is currently in Phase 3 clinical development, with one completed trial in Japanese children with bronchial asthma.

Who makes Conventional Asthma Therapy?

Conventional Asthma Therapy is developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. The company is conducting clinical trials to evaluate the therapy's safety and efficacy in patients with asthma.

What phase is Conventional Asthma Therapy in?

Conventional Asthma Therapy is in Phase 3 clinical development. It is an investigational therapy, meaning it has not yet been approved by regulatory authorities. One Phase 3 trial has been completed, and the therapy is still undergoing clinical evaluation for the treatment of asthma.

What clinical trials is Conventional Asthma Therapy in?

Conventional Asthma Therapy has one completed clinical trial, NCT00509028, titled 'Safety and Efficacy Study of Budesonide (Pulmicort®) Turbuhaler® in Japanese Children With Bronchial Asthma.' This Phase 3 trial enrolled 241 participants with asthma in Japan and was completed.

Is Conventional Asthma Therapy the same as Budesonide?

Conventional Asthma Therapy is associated with the drug budesonide, as indicated by the clinical trial NCT00509028, which studied budesonide (Pulmicort®) Turbuhaler®. The therapy is being developed by AstraZeneca PLC for the treatment of asthma.