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fluticasone/salmeterol

Phase 3

Asthma | Small molecule | Respiratory |AstraZeneca PLC|Last Updated: Aug 24, 2011

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials4
Total Enrollment1,536

FDA Designations

No designations recorded

Clinical trial landscape

fluticasone/salmeterol · 4 trials · 1 indication

Phase 3 4
NCT00504062Open-label, Safety and Efficacy Study of Pulmicort® Turbuhaler® in Japanese Children With Bronchial AsthmaAsthma
COMPLETED240 Analytics
NCT00646594Atlantis SymbicortAsthma
COMPLETED1,200 Analytics
NCT00646620Symbicort Onset of Action 1Asthma
COMPLETED48 Analytics
NCT00646009Symbicort Onset of Action 2Asthma
COMPLETED48 Analytics
PHASE3COMPLETED
Open-label, Safety and Efficacy Study of Pulmicort® Turbuhaler® in Japanese Children With Bronchial Asthma
AsthmaUnlock trial analytics
PHASE3COMPLETED
Atlantis Symbicort
AsthmaUnlock trial analytics
PHASE3COMPLETED
Symbicort Onset of Action 1
AsthmaUnlock trial analytics
PHASE3COMPLETED
Symbicort Onset of Action 2
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

To investigate the effect of budesonide Turbuhaler® 100 μg/dose twice daily and 200 μg/dose twice daily for 6 weeks in Japanese children with bronchial asthma aged 5 years to 15 years old in need for inhaled glucocorticosteroid treatment
6 weeks
Asthma control assessed by asthma exacerbations
Continuosly throughout the treatment period
FEV1 3 minutes post dose
4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart)

Secondary Endpoints

To investigate the safety of budesonide Turbuhaler 100 μg/dose twice daily and 200 μg/dose twice daily for 6 weeks in Japanese children with bronchial asthma aged 5 years to 15 years old in need for inhaled glucocorticosteroid treatment
6 weeks
To compare the efficacy of budesonide Turbuhaler 100 μg/dose twice daily and 200 μg/dose twice daily for 6 weeks to that of fluticasone Diskus® 50 μg/dose twice daily and 100 μg/dose twice daily for 6 weeks
6 weeks
Efficacy of Symbicort compared with Advair as assessed by use of rescue medication, asthma symptoms, lung function tests, quality of life reports, patient reported asthma control and patient satisfaction of Symbicort.
Daily and at 1, 3 and 6 months after start of treatmen
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALbudesonide/formoterol
2ACTIVE_COMPARATORfluticasone/salmeterol
3ACTIVE_COMPARATORalbuterol

Interventions

NameTypeDescription
budesonideDRUG -
fluticasoneDRUG -
budesonide/formoterol (Symbicort)DRUG -
fluticasone/salmeterol (Advair)DRUG -
fluticasone/salmeterol (Advair Diskus)DRUG -
albuterol (Ventolin)DRUG -
budesonide/formoterolDRUG -
fluticasone/salmeterolDRUG -
albuterolDRUG -
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Eligibility Criteria

Age Range5 Years to 15 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Provision of signed written informed consent by patient's legal representative; when possible a signed written informed consent should be obtained from the patient themselves * Patients diagnosed as having bronchial asthma regardless of type of asthma i.e. perennial or seasona...

Countries:Japan
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Frequently asked questions about fluticasone/salmeterol

What is fluticasone/salmeterol used for?

Fluticasone/salmeterol is used for the treatment of asthma. It is a combination therapy being developed by AstraZeneca PLC (AZN) and is currently in Phase 3 clinical development. The drug is a small molecule administered as an inhaled treatment for respiratory conditions.

Who makes fluticasone/salmeterol?

Fluticasone/salmeterol is developed by AstraZeneca PLC, a multinational pharmaceutical company traded under the ticker AZN. The drug is being investigated for the treatment of asthma and is currently in Phase 3 clinical trials.

What phase is fluticasone/salmeterol in?

Fluticasone/salmeterol is in Phase 3 clinical development. It is an investigational drug for asthma and has not been approved by regulatory authorities. All four clinical trials for this drug have been completed, with no active trials currently ongoing.

What clinical trials is fluticasone/salmeterol in?

Fluticasone/salmeterol has been studied in four completed Phase 3 clinical trials: NCT00504062, NCT00646009, NCT00646594, and NCT00646620. These trials enrolled a total of 1,536 participants with asthma, including studies in Japanese children and assessments of onset of action.

Is fluticasone/salmeterol the same as Symbicort?

Fluticasone/salmeterol is associated with the brand name Symbicort in clinical trial records. Trials NCT00646009, NCT00646594, and NCT00646620 reference Symbicort in their titles, indicating that fluticasone/salmeterol is the active ingredient in this product.