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Terbutaline Turbuhaler

Phase 3

Asthma | Small molecule | Respiratory |AstraZeneca PLC|Trials Updated: Aug 31, 2012

Terbutaline Turbuhaler development status

Highest phase Phase 3
Registered trials 4 across 1 sponsor since Oct 2005

Terbutaline Turbuhaler target and mechanism

Molecular targetADRB2
Target classAgonist
ModalitySmall molecule

Also known as Bricanyl Turbuhaler

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Terbutaline Turbuhaler clinical trials

Terbutaline Turbuhaler · 1 trial · 1 indication

Phase 3 1
NCT01096017To Investigate the Relative Efficacy of Terbutaline Turbuhaler® and Salbutamol Pressurized Metered Dose Inhaler (pMDI) a Single Blind StudyAsthma
COMPLETED24 Analytics
PHASE3COMPLETED
To Investigate the Relative Efficacy of Terbutaline Turbuhaler® and Salbutamol Pressurized Metered Dose Inhaler (pMDI) a Single Blind Study
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

FEV1 (Forced Expiratory Volume in 1 Second) Area Under Curve (AUC) 0-4 Hours After Drug Inhalation
At two visits during a maximum of 15 days. FEV1 timepoints: all time points t=5, 15, 30, 60, 120, 180 and 240 minutes.

FEV1 (Forced Expiratory Volume in 1 second) AUC 0-4 hours after drug inhalation

Secondary Endpoints

FEV1 (Forced Expiratory Volume in 1 Second) at 5 Minutes After Inhalations of Study Drug as Percentage of Pre-dose
At two visits during a maximum of 15 days
FEV1 (Forced Expiratory Volume in 1 Second) at 15 Minutes After Inhalations of Study Drug as Percentage of Pre-dose
At two visits during a maximum of 15 days
FEV1 (Forced Expiratory Volume in 1 Second) at 30 Minutes After Inhalations of Study Drug as Percentage of Pre-dose
At two visits during a maximum of 15 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALTerbutaline Turbuhaler® 0.4mg + pMDI placebo pMDI ⇒salbutamol pMDI 200 μg +placebo Turbuhaler®
2EXPERIMENTALsalbutamol pMDI 200 μg +placebo Turbuhaler® ⇒Terbutaline Turbuhaler® 0.4mg + pMDI placebo pMDI

Interventions

NameTypeDescription
Terbutaline Turbuhaler®DRUG0.4 mg, inhalation, single dose
Salbutamol pMDIDRUG200 μg, inhalation, single dose
pMDI placebo pMDIOTHERPlacebo pMDI 2 inhalations
Placebo Turbuhaler®OTHERPlacebo Turbuhaler 1 inhalation
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Eligibility Criteria

Age Range16 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * On ICS for at least 3 months from Visit 2 and with a prescribed constant dose during the 4 weeks prior to Visit 2 * Forced Expiratory Volume in 1 Second (FEV1) of at least 50 % of predicted normal value pre-bronchodilator * Reversible airway obstruction according to reversibil...

Countries:Japan
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Frequently asked questions about Terbutaline Turbuhaler

What is Terbutaline Turbuhaler used for?

Terbutaline Turbuhaler is an inhaled asthma medicine developed by AstraZeneca PLC. It is a small molecule beta-2 adrenergic receptor agonist delivered as a dry powder through the Turbuhaler device, and it is intended for patients with asthma. It has been studied in a Phase 3 trial in Japan.

How does Terbutaline Turbuhaler work?

Terbutaline Turbuhaler works as an agonist of ADRB2, the beta-2 adrenergic receptor. By activating this receptor in the airways, terbutaline promotes bronchodilation, helping to relax airway smooth muscle and improve airflow in patients with asthma. The drug is a small molecule delivered by inhalation.

Who makes Terbutaline Turbuhaler?

Terbutaline Turbuhaler is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the company behind the Turbuhaler dry powder inhaler technology used to deliver this asthma therapy.

What phase is Terbutaline Turbuhaler in?

Terbutaline Turbuhaler is in Phase 3 development for asthma. It is an investigational product and is not described as approved. The Phase 3 trial NCT01096017 has been completed, and no active trials are currently listed for this asset.

What clinical trials is Terbutaline Turbuhaler in?

Terbutaline Turbuhaler has been evaluated in one completed Phase 3 trial, NCT01096017, titled a study to investigate the relative efficacy of Terbutaline Turbuhaler and salbutamol pressurized metered dose inhaler. The single-blind, controlled study enrolled 24 participants with asthma in Japan, including patients aged 16 years and older.