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Symbicort TBH- Turbuhaler

Phase 3

Asthma | Small molecule | Respiratory |AstraZeneca PLC|Trials 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

Symbicort TBH- Turbuhaler clinical trials

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?

Symbicort TBH - Turbuhaler is an investigational small molecule therapy being developed by AstraZeneca PLC for the treatment of asthma. It is a Phase 3 candidate in the respiratory therapeutic area. The product is also written as Symbicort TBH- Turbuhaler, and both names refer to the same asset.

What is Symbicort TBH - Turbuhaler used for in asthma?

Symbicort TBH - Turbuhaler is being studied for the treatment of persistent asthma in adults. The single Phase 3 trial enrolled patients aged 18 years and older with persistent asthma, comparing single inhaler therapy against conventional best practice. It is not described as approved and remains in clinical development.

Who makes Symbicort TBH - Turbuhaler?

Symbicort TBH - Turbuhaler is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor behind the clinical program for this asthma candidate.

What phase is Symbicort TBH - Turbuhaler in?

Symbicort TBH - Turbuhaler is in Phase 3 development. One Phase 3 trial has been completed, and no trials are currently active. The program is investigational and has not been described as approved for any indication.

What clinical trials is Symbicort TBH - Turbuhaler in?

Symbicort TBH - Turbuhaler has been evaluated in one completed Phase 3 trial, NCT00628758, titled A Comparison of Symbicort Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma. The trial enrolled 430 adults in Turkey, was randomized and controlled, and included both male and female participants.

Is Symbicort TBH - Turbuhaler the same as Symbicort TBH- Turbuhaler?

Yes, Symbicort TBH - Turbuhaler and Symbicort TBH- Turbuhaler are the same asset, with only minor punctuation differences in the name. Both refer to the AstraZeneca PLC Phase 3 asthma candidate evaluated in trial NCT00628758.