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ciclesonide

Phase 4FDA approved

Asthma | Small molecule | Respiratory |Takeda Pharmaceutical Company Limited|Trials Updated: Oct 21, 2009

ciclesonide development status

FDA approval on record Nov 21, 2007 as Omnaris
Approval holderNycomed Us Inc
ApplicationNDA022124
Highest phase Phase 4 (NCT01430260)
Phase scored for TAKPhase 3
Registered trials 36 across 5 sponsors since Sep 2005

ciclesonide target and mechanism

Molecular targetNR3C1
Target classAgonist
ModalitySmall molecule

Also known as ciclesonide (Alvesco)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment26

FDA Designations

No designations recorded

ciclesonide clinical trials

ciclesonide · 1 trial · 1 indication

Phase 3 1
NCT00525772Effect of Ciclesonide on Exercise Induced BronchoconstrictionAsthma
COMPLETED26 Analytics
PHASE3COMPLETED
Effect of Ciclesonide on Exercise Induced Bronchoconstriction
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

change in maximum fall in FEV1 induced by dry air exercise challenge after treatment compared to the respective pretreatment value
at 1 week of treatment

Secondary Endpoints

Changes in sputum cell counts,bronchial responsiveness to mannitol and other clinical parameters of asthma control after treatment compared to respective pre-treatment value.
after 1, 2, 3, weeks of treatment
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1ACTIVE_COMPARATORciclesonide 50 and 200ug
2ACTIVE_COMPARATORciclesonide 100ug and 400ug

Interventions

NameTypeDescription
ciclesonideDRUGlow dose- 50ug and 200ug
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Eligibility Criteria

Age Range12 Years to 30 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * stable asthma not on maintenance asthma medications * exercise induced bronchoconstriction on dry air exercise challenge. Exclusion Criteria: * other significant co-morbidity or treatments that might interfere with the conduct or results of the study * fail to return to base...

Countries:Canada
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Frequently asked questions about ciclesonide

What is ciclesonide used for?

Ciclesonide is an inhaled small molecule developed for the treatment of asthma. It is being studied in a Phase 3 clinical program in respiratory medicine, with a completed trial evaluating its effect on exercise induced bronchoconstriction in patients with asthma.

What does ciclesonide target?

Ciclesonide targets NR3C1, the glucocorticoid receptor, and acts as an agonist at this receptor. This target class places ciclesonide among the corticosteroid class of respiratory therapies used to manage airway inflammation in asthma.

Who makes ciclesonide?

Ciclesonide is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is responsible for the clinical development program for the drug in asthma.

What phase is ciclesonide in?

Ciclesonide is in Phase 3 clinical development for asthma. It is an investigational small molecule and is not described as approved; the development program includes one completed Phase 3 trial, with no active trials currently listed.

What clinical trials is ciclesonide in?

Ciclesonide has been studied in the completed Phase 3 trial NCT00525772, titled Effect of Ciclesonide on Exercise Induced Bronchoconstriction. The trial enrolled 26 participants with asthma in Canada, was randomized, double blind, and active controlled, and included participants aged 12 years and older.