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Terbutaline sulphate

Phase 3

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

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

Clinical trial landscape

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 in asthma?

Terbutaline sulphate is a small molecule used for the treatment of asthma. It is being developed by AstraZeneca PLC as a bronchodilator to relieve symptoms associated with the condition. The drug is currently in Phase 3 clinical development and is administered via inhalation.

What does Terbutaline sulphate target?

Terbutaline sulphate is a beta-2 adrenergic receptor agonist. It works by stimulating beta-2 receptors in the airways, which leads to relaxation of bronchial smooth muscle and relief of bronchospasm in asthma patients. This mechanism helps to improve airflow and reduce asthma symptoms.

Who makes Terbutaline sulphate?

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

What phase is Terbutaline sulphate in?

Terbutaline sulphate is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 3 trial has been completed, and the results will inform potential regulatory submissions for marketing approval.

What clinical trials is Terbutaline sulphate in?

Terbutaline sulphate has one completed Phase 3 clinical trial registered as NCT02322788. This randomized, double-blind, placebo-controlled study enrolled 95 participants with asthma across Canada, Netherlands, and Sweden. The trial compared the efficacy of Bricanyl M2 and Bricanyl M3 at 0.5 and 1.5 mg dose levels.

Is Terbutaline sulphate the same as Bricanyl?

Terbutaline sulphate is the active ingredient in the product Bricanyl. The clinical trial NCT02322788 specifically evaluated Bricanyl Turbuhaler M2 and M3 formulations, which contain terbutaline sulphate. Thus, Bricanyl is a brand name for terbutaline sulphate.