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Pulmicort Respules

Phase 3

Asthma | Small molecule | Respiratory |AstraZeneca PLC|Last Updated: Mar 25, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment54

FDA Designations

No designations recorded

Clinical trial landscape

Pulmicort Respules · 1 trial · 1 indication

Phase 3 1
NCT00232648Long Term Safety & Efficacy of Budesonide Inhalation Suspension in Japanese Children With Bronchial AsthmaAsthma
COMPLETED54 Analytics
PHASE3COMPLETED
Long Term Safety & Efficacy of Budesonide Inhalation Suspension in Japanese Children With Bronchial Asthma
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

The safety profile of long-term use of budesonide inhalation suspension assessed by evaluation of frequency and intensity of adverse events, plasma cortisol, physical examination, height, weight and clinical laboratory values.

Secondary Endpoints

The efficacy of budesonide inhalation suspension assessed by overall evaluation on asthma control by investigator
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Interventions

NameTypeDescription
Pulmicort (budesonide) RespulesDRUG -
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Eligibility Criteria

Age Range13 Months to 65 Months
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: \- 1. Clinical benefit from continued treatment with budesonide inhalation suspension was expected in patients with bronchial asthma participating in study SD-004-0765, as judged by the investigator(s) at the completion of that study (Visit 11, Week 24), and the patient's caregi...

Countries:Japan
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Frequently asked questions about Pulmicort Respules

What is Pulmicort Respules used for?

Pulmicort Respules is used for asthma. It is an investigational small molecule being developed by AstraZeneca PLC for the treatment of asthma, specifically studied in Japanese children with bronchial asthma. The drug is currently in Phase 3 clinical development.

Who makes Pulmicort Respules?

Pulmicort Respules is developed by AstraZeneca PLC, a company listed on the stock exchange under the ticker AZN. The drug is being studied for the treatment of asthma and is currently in Phase 3 clinical development.

What phase is Pulmicort Respules in?

Pulmicort Respules is in Phase 3 clinical development. It is an investigational drug for asthma and has not been approved by regulatory authorities. The Phase 3 trial has been completed, with a total enrollment of 54 participants.

What clinical trials is Pulmicort Respules in?

Pulmicort Respules has one completed Phase 3 clinical trial, identified as NCT00232648. The trial, titled 'Long Term Safety & Efficacy of Budesonide Inhalation Suspension in Japanese Children With Bronchial Asthma,' enrolled 54 participants in Japan and was not randomized or double-blinded.

Is Pulmicort Respules the same as budesonide?

Pulmicort Respules is a budesonide inhalation suspension. The clinical trial for the drug is titled 'Long Term Safety & Efficacy of Budesonide Inhalation Suspension in Japanese Children With Bronchial Asthma,' indicating that budesonide is the active ingredient in Pulmicort Respules.