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Fluticasone Discus 250 µg

Phase 3

Asthma | Small molecule | Respiratory |AstraZeneca PLC|Last Updated: Mar 17, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedUNCONTROLLED
Total Trials1
Total Enrollment1,600

FDA Designations

No designations recorded

Clinical trial landscape

Fluticasone Discus 250 µg · 1 trial · 1 indication

Phase 3 1
NCT00252863DESOLO - SiT Peri-Launch: A Comparison of Symbicort Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma in AdultsAsthma
COMPLETED1,600 Analytics
PHASE3COMPLETED
DESOLO - SiT Peri-Launch: A Comparison of Symbicort Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma in Adults
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

Time to first severe asthma exacerbation

Secondary Endpoints

Number of severe asthma exacerbations
Mean use of as-needed medication
Change in forced expiratory volume in 1 second (FEV1) from the end of run-in to the end of the study period
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Symbicort, used twice daily (b.i.d) and as needed (prn)DRUG -
Budesonide Turbuhaler 200 µgDRUG -
Fluticasone Discus 250 µgDRUG -
Formoterol Turbuhaler 4.5 µgDRUG -
Terbutaline Turbuhaler 0.5 mgDRUG -
Salbutamol pressurized metered dose inhaler (pMDI) 100 µgDRUG -
Salmeterol Discus 50 µgDRUG -
Budesonide/Formoterol Turbuhaler 160/4.5 µgDRUG -
Fluticasone/Salmeterol Discus 250/50 µgDRUG -
Fluticasone/Salmeterol Discus 500/50 µgDRUG -
Theophylline 200 mgDRUG -
Theophylline 300 mgDRUG -
Singulair 10 mgDRUG -
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites169

Inclusion Criteria: * Patients with asthma, either well-controlled on a regular therapy with a combination of long-acting beta-agonists and inhaled corticosteroids or symptomatic on therapy with inhaled corticosteroids alone. Exclusion Criteria: * Any other significant lung disease other than ast...

Countries:Germany
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Frequently asked questions about Fluticasone Discus 250 µg

What is Fluticasone Discus 250 µg used for?

Fluticasone Discus 250 µg is an inhaled corticosteroid used for the treatment of persistent asthma in adults. It is being developed by AstraZeneca PLC (AZN) and is currently in Phase 3 clinical development. The drug is administered via a dry powder inhaler and is intended to reduce airway inflammation in asthma patients.

Who makes Fluticasone Discus 250 µg?

Fluticasone Discus 250 µg is developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker AZN. The company is conducting clinical trials to evaluate the drug's efficacy and safety in patients with persistent asthma.

What phase is Fluticasone Discus 250 µg in?

Fluticasone Discus 250 µg is currently in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities. The Phase 3 trial, NCT00252863, has been completed, and the drug is being studied for the treatment of persistent asthma in adults.

What clinical trials is Fluticasone Discus 250 µg in?

Fluticasone Discus 250 µg has one completed Phase 3 clinical trial, NCT00252863, titled 'DESOLO - SiT Peri-Launch: A Comparison of Symbicort Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma in Adults.' The trial enrolled 1,600 participants in Germany and was not randomized or double-blinded.

Is Fluticasone Discus 250 µg the same as Fluticasone?

Fluticasone Discus 250 µg is a specific formulation and dosage of fluticasone, an inhaled corticosteroid. The 'Discus' refers to the dry powder inhaler device used to deliver the medication. While fluticasone is the active ingredient, this product is specifically designed for asthma treatment and is being developed by AstraZeneca.