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Terbutaline sulphate

Phase 3FDA approved

Asthma | Small molecule | Respiratory |AstraZeneca PLC|Trials Updated: Jan 13, 2017

Terbutaline sulphate development status

FDA approval on record Dec 7, 2007 as Bricanyl
Approval holderSanofi Aventis Us
ApplicationNDA017466
Highest phase Phase 3
Registered trials 1 across 1 sponsor since Dec 2014

Terbutaline sulphate target and mechanism

Molecular targetADRB2
Target classAgonist
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment95

FDA Designations

No designations recorded

Terbutaline sulphate clinical trials

Terbutaline sulphate · 1 trial · 1 indication

Phase 3 1
NCT02322788Comparing the Efficacy of Bricanyl M2 and Bricanyl M3 at 0.5 and 1.5 mg Dose Levels, to Allow for a Switch From Bricanyl Turbuhaler M2 to Bricanyl Turbuhaler M3Asthma
COMPLETED95 Analytics
PHASE3COMPLETED
Comparing the Efficacy of Bricanyl M2 and Bricanyl M3 at 0.5 and 1.5 mg Dose Levels, to Allow for a Switch From Bricanyl Turbuhaler M2 to Bricanyl Turbuhaler M3
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

Provocative Concentration of Methacholine Which Produces a 20% Fall in FEV1 (PC20)
4 cross-over treatments (<1 day each) with 2-10 days between treatment washout periods
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Study Design & Arms

AllocationRANDOMIZED
MaskingTRIPLE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Bricanyl Turbuhaler M2, ActiveACTIVE_COMPARATORTerbutaline sulphate powder for inhalation, 0.5 mg terbutaline per inhalation
Bricanyl Turbuhaler M3, ActiveACTIVE_COMPARATORTerbutaline sulphate powder for inhalation, 0.4 mg terbutaline per inhalation
Turbuhaler M2, PlaceboPLACEBO_COMPARATORPlacebo powder for inhalation
Turbuhaler M3, PlaceboPLACEBO_COMPARATORPlacebo powder for inhalation

Interventions

NameTypeDescription
Terbutaline sulphateDRUGBricanyl Turbuhaler M2
Placebo for terbutaline sulphateDRUGPlacebo Turbuhaler M2
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: - Female and male aged 18 and 65 years. * At least 6 months of documented clinical diagnosis of asthma as defined by GINA 2012 or American Thoracic Society (Expert Panel Report 3 2007) prior to visit 1 * Stable asthmatics on SABA alone, on low dose ICS (200-400 µg budesonide cor...

Countries:CanadaNetherlandsSweden
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Frequently asked questions about Terbutaline sulphate

What is terbutaline sulphate used for?

Terbutaline sulphate is used for the treatment of asthma. It is a small molecule bronchodilator developed by AstraZeneca PLC. The drug has been studied in a Phase 3 clinical trial in adults with asthma, and it is delivered via inhalation using the Bricanyl Turbuhaler device.

How does terbutaline sulphate work?

Terbutaline sulphate works as an agonist at the beta-2 adrenergic receptor, also known as ADRB2. By activating this receptor, it relaxes the smooth muscle in the airways, which helps to open them and relieve asthma symptoms. This makes it a bronchodilator.

Who makes terbutaline sulphate?

Terbutaline sulphate is made by AstraZeneca PLC, which trades under the ticker symbol AZN. AstraZeneca is the developer of the drug and the Bricanyl Turbuhaler delivery device.

What phase is terbutaline sulphate in?

Terbutaline sulphate is in Phase 3 clinical development for asthma. It is an investigational product and has not been approved by the FDA for this specific use. The Phase 3 trial has been completed.

What clinical trials is terbutaline sulphate in?

Terbutaline sulphate has been studied in a completed Phase 3 trial, NCT02322788. This trial compared Bricanyl M2 and Bricanyl M3 at 0.5 and 1.5 mg dose levels in 95 adults with asthma. It was randomized, double-blind, and placebo-controlled, and took place in Canada, the Netherlands, and Sweden.

Is terbutaline sulphate the same as Bricanyl?

Yes, terbutaline sulphate is the active ingredient in Bricanyl, a brand name for the drug. Bricanyl is available in a Turbuhaler device, and the clinical trial NCT02322788 compared different versions of the Bricanyl Turbuhaler.