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terbutaline

Phase 3

Chronic Obstructive Pulmonary Disease | Small molecule | Respiratory |AstraZeneca PLC|Last Updated: Aug 14, 2012

Success Probability

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLED
Total Trials1
Total Enrollment315

FDA Designations

No designations recorded

Clinical trial landscape

terbutaline · 2 trials · 2 indications

Phase 3 1Phase 2 1
NCT00421122Efficacy and Safety Study of Symbicort Turbuhaler in Chinese Patients With COPDChronic Obstructive Pulmonary Disease
COMPLETED315 Analytics
PHASE3COMPLETED
Efficacy and Safety Study of Symbicort Turbuhaler in Chinese Patients With COPD
Chronic Obstructive Pulmonary DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Post-study medication FEV1
1 hour after medication
Percent Change in Maximum Post-exercise Forced Expiratory Volume in One Second (FEV1) Fall After 6 Weeks
Baseline and Visit 6

FEV1

Secondary Endpoints

FVC
Pre dose and 1 hour post dose
FEV1
Pre-dose and 15 minutes post dose
SGRQ symptom scores
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1ACTIVE_COMPARATORBricasol®
2EXPERIMENTALBricasol® + Pulmicort®
3EXPERIMENTALBricasol® + Symbicort®
AACTIVE_COMPARATORbudesonide 400yg + terbutaline 0.4 mg as-needed
BACTIVE_COMPARATORplacebo + terbutaline 0.4 mg as-needed
CACTIVE_COMPARATORplacebo + budesonide/formoterol 160/4.5 yg as-needed

Interventions

NameTypeDescription
budesonide/formoterol (Symbicort)DRUGinhalation therapy
budesonide (Pulmicort)DRUGinhalation
terbutaline sulfate (Bricasol)DRUGinhalation therapy
budesonideDRUG400 yg x 1
terbutalineDRUG0.4 mg as-needed
budesonide/formoterolDRUG160/4.5 yg as-needed
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Eligibility Criteria

Age Range40 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites8

Inclusion Criteria: * Signed and dated inform consent * Out-patient, clinical diagnosis of COPD * Men or women at the age of 40 or over Exclusion Criteria: * A history of asthma * Seasonal allergic rhinitis before 40 years of age * Patients with significant or unstable ischemic heart disease, arr...

Countries:ChinaNorwaySweden
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Frequently asked questions about terbutaline

What is terbutaline used for?

Terbutaline is used for exercise induced asthma and chronic obstructive pulmonary disease (COPD). It is a small molecule respiratory therapy being developed by AstraZeneca PLC (AZN). In clinical studies, terbutaline has been evaluated as a bronchodilator for patients with these conditions.

Who makes terbutaline?

Terbutaline is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the company behind the clinical development of terbutaline for respiratory indications including exercise induced asthma and chronic obstructive pulmonary disease.

What phase is terbutaline in?

Terbutaline has been studied in Phase 3 clinical trials for chronic obstructive pulmonary disease and in Phase 2 trials for exercise induced asthma. It remains an investigational drug in clinical development, with completed trials but no approved status indicated in the available data.

What clinical trials is terbutaline in?

Terbutaline has been studied in two completed clinical trials. NCT00421122 was a Phase 3 study in 315 Chinese patients with COPD, and NCT00989833 was a Phase 2 study in 66 patients with exercise induced asthma. Both trials were randomized, double blind, and active controlled.

Is terbutaline the same as Bricanyl?

Yes, terbutaline is the same as Bricanyl. In clinical trial NCT00989833, Bricanyl is referenced as a brand name for terbutaline used as-needed in asthma patients. This trial compared Bricanyl as-needed against other treatments for exercise induced asthma.