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Pulmicort Turbuhaler

Phase 3

Asthma | Small molecule | Respiratory |AstraZeneca PLC|Last Updated: Mar 11, 2011

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment108

FDA Designations

No designations recorded

Clinical trial landscape

Pulmicort Turbuhaler · 1 trial · 1 indication

Phase 3 1
NCT00855959Study to Evaluate Efficacy and Safety of Pulmicort Respules in Japanese Adult Asthmatic PatientsAsthma
COMPLETED108 Analytics
PHASE3COMPLETED
Study to Evaluate Efficacy and Safety of Pulmicort Respules in Japanese Adult Asthmatic Patients
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

Morning Peak Expiratory Flow (mPEF)
6 weeks

Change in morning peak expiratory flow (mPEF) from baseline (mean of the last 14 days of the period on Pulmicort Turbuhaler) to Week 6 (mean of the last 14 days of the period on Pulmicort Respules)

Secondary Endpoints

Evening Peak Expiratory Flow (ePEF)
6 weeks
Asthma Symptom Score (Daytime); Score of 0-3 (0 = no Asthma Symptoms - 3 = Severe Symptoms)
6 weeks
Asthma Symptom Score (Night-time); Score of 0-3 (0 = no Asthma Symptoms - 3 = Severe Symptoms)
6 weeks
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALFour weeks treatment with either Pulmicort Turbuhaler at a dose of 400 μg or 200 ug twice daily, followed by 6 weeks treatment with Pulmicort Respules at a dose of 1.0 mg twice daily or 0.5 mg twice daily/1.0 mg once daily
2EXPERIMENTALPulmicort Turbuhaler at a dose of 200 μg twice daily and Pulmicort Respules at a dose of 0.5 mg twice daily or 1.0 mg once daily (low dose)

Interventions

NameTypeDescription
BudesonideDRUGInhalation powder, inhalation, twice daily, 4 weeks followed by Suspension for nebulisation, inhalation, once or twice daily, 6 weeks
Pulmicort TurbuhalerDRUGPulmicort Turbuhaler 200 µg, Dry powder inhaler, budesonide 200 µg/dose, 112 doses/Turbuhaler
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Eligibility Criteria

Age Range16 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites6

Inclusion Criteria: * Provision of informed consent prior to any study specific procedures. * A minimum of 6 months documented history of asthma according to the JGL 2006 definition * Asthma patients under prescribed treatment with ICS at least 3 months before Visit 2. Exclusion Criteria: * Curre...

Countries:Japan
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Frequently asked questions about Pulmicort Turbuhaler

What is Pulmicort Turbuhaler used for?

Pulmicort Turbuhaler is used for the treatment of asthma. It is an inhaled corticosteroid that helps reduce inflammation in the airways, improving asthma control. The drug is being developed by AstraZeneca PLC (ticker: AZN) and is currently in Phase 3 clinical development for this indication.

How does Pulmicort Turbuhaler work?

Pulmicort Turbuhaler contains budesonide, a corticosteroid that works by reducing inflammation in the airways. It is a small molecule that acts locally in the lungs to decrease swelling and mucus production, helping to prevent asthma symptoms and improve lung function.

Who makes Pulmicort Turbuhaler?

Pulmicort Turbuhaler is developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker AZN. AstraZeneca is conducting clinical trials to evaluate the efficacy and safety of this drug for the treatment of asthma.

What phase is Pulmicort Turbuhaler in?

Pulmicort Turbuhaler is in Phase 3 clinical development for asthma. It is an investigational drug and has not yet been approved by regulatory authorities. One Phase 3 trial has been completed, and the drug is not currently in active clinical trials.

What clinical trials is Pulmicort Turbuhaler in?

Pulmicort Turbuhaler has been studied in one completed Phase 3 clinical trial, identified as NCT00855959. This trial, titled 'Study to Evaluate Efficacy and Safety of Pulmicort Respules in Japanese Adult Asthmatic Patients,' enrolled 108 participants aged 16 years and older in Japan.

Is Pulmicort Turbuhaler the same as Pulmicort Respules?

Pulmicort Turbuhaler and Pulmicort Respules are both formulations of budesonide, but they are different delivery devices. The Turbuhaler is a dry powder inhaler, while Respules are nebulized suspension. The clinical trial NCT00855959 evaluated Pulmicort Respules in Japanese adult asthmatic patients.