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Symbicort TBH- Turbuhaler

Phase 3

Asthma | Small molecule | Respiratory |AstraZeneca PLC|Last Updated: Aug 14, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment430

FDA Designations

No designations recorded

Clinical trial landscape

Symbicort TBH- Turbuhaler · 1 trial · 1 indication

Phase 3 1
NCT00628758A Comparison of Symbicort® Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent AsthmaAsthma
COMPLETED430 Analytics
PHASE3COMPLETED
A Comparison of Symbicort® Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

Time to First Severe Asthma Exacerbation
26 weeks

Time to severe exacerbation among patients

Secondary Endpoints

Number of Severe Asthma Exacerbations
26 weeks
Change in Standardised Asthma Quality of Life Questionnaire (AQLQ(S)) Score
Baseline and 26 weeks
Mean Use of As-needed Medication Per Day During Treatment Period
Daily recording during the treatment period of 26 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SymbicortEXPERIMENTALSymbicort Single Inhaler Therapy ( Turbuhaler 160/4.5 microgram, 1 inhalation bid + as needed)
Conventional BPEXPERIMENTALConventional Best Practice for Treatment of Asthma

Interventions

NameTypeDescription
Symbicort TBH - TurbuhalerDRUGSymbicort Single Inhaler Therapy ( Turbuhaler 160/4.5 microgram, 1 inhalation bid + as needed)
beta-II-agonist, inhale steroidDRUGSalbulin inh. 200-400 dosage 100 microgram (mcg)/dosage Salbutamol Sustained Release(SR)capsule 4 mg/8 mg Salbutol tablet (tb) 2 mg Salbutol forte syrup 2 mg/5 ml Ventolin tb, syrup, intravenous(IV),5mgx10 ampule(amp) Ventolin inhaler (inh) 200 dosage, 100 mcg/dosage Ventolin nebul 2.5 mg Volmax tb 4 mg/8 mg Vent-o-sal inh 100 mcg/200 dosage Combivent inh 100 mcg/dosage Combivent neb 2.5 mg/dosage Bricanyl tb 2.5 mg Bricanyl durules ret tb 5 mg Bricanyl syrup 30mg Bricanyl inhaler 0.25 mg/dosage, 400 dosage Bricanyl turbuhaler 0.5 mg/dosage, 200dosage
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: * Signed informed consent form. If the patient cannot read and write, verbal consent from the patient is required. * Ability to read and write in Turkish * Female or male outpatients aged 18 years * Minimum of 3 months history of asthma, diagnosed according to the American Thora...

Countries:Turkey (Türkiye)
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Frequently asked questions about Symbicort TBH- Turbuhaler

What is Symbicort TBH-Turbuhaler used for?

Symbicort TBH-Turbuhaler is used for the treatment of persistent asthma in adults. It is a small molecule respiratory therapy developed by AstraZeneca PLC. The drug is administered via a Turbuhaler device and is intended for patients aged 18 years and older.

Who makes Symbicort TBH-Turbuhaler?

Symbicort TBH-Turbuhaler is developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker AZN. AstraZeneca is responsible for the research, development, and commercialization of this asthma treatment.

What phase is Symbicort TBH-Turbuhaler in?

Symbicort TBH-Turbuhaler is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the drug remains under evaluation for the treatment of persistent asthma.

What clinical trials is Symbicort TBH-Turbuhaler in?

Symbicort TBH-Turbuhaler has one completed Phase 3 clinical trial, identified by the NCT number NCT00628758. The trial, titled 'A Comparison of Symbicort® Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma,' enrolled 430 participants in Turkey and was a randomized, controlled study.

Is Symbicort TBH-Turbuhaler the same as Symbicort?

Symbicort TBH-Turbuhaler is a specific formulation of Symbicort, delivered via a Turbuhaler device. The drug is developed by AstraZeneca and is being studied for asthma. The trial NCT00628758 compares this single inhaler therapy with conventional best practice for persistent asthma.