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Terbutaline Turbuhaler

Phase 3

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

Success Probability

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials2
Total Enrollment124

FDA Designations

No designations recorded

Clinical trial landscape

Terbutaline Turbuhaler · 2 trials · 1 indication

Phase 3 2
NCT01096017To Investigate the Relative Efficacy of Terbutaline Turbuhaler® and Salbutamol Pressurized Metered Dose Inhaler (pMDI) a Single Blind StudyAsthma
COMPLETED24 Analytics
NCT00244608A Comparison of the Control of Asthma Provided by Symbicort® Turbuhaler® Versus Symbicort® Turbuhaler® Plus Pulmicort® Turbuhaler® Plus Terbutaline Turbuhaler®Asthma
COMPLETED100 Analytics
PHASE3COMPLETED
To Investigate the Relative Efficacy of Terbutaline Turbuhaler® and Salbutamol Pressurized Metered Dose Inhaler (pMDI) a Single Blind Study
AsthmaUnlock trial analytics
PHASE3COMPLETED
A Comparison of the Control of Asthma Provided by Symbicort® Turbuhaler® Versus Symbicort® Turbuhaler® Plus Pulmicort® Turbuhaler® Plus Terbutaline Turbuhaler®
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

Change in eosinophils in bronchial biopsies (first and last visit) and in sputum (5 times during the 12-month treatment period)

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
Budesonide/Formoterol TurbuhalerDRUG -
Budesonide Turbuhaler (Pulmicort)DRUG -
Terbutaline TurbuhalerDRUG -
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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:JapanDenmarkFranceGermanySpainSwedenUnited Kingdom
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Frequently asked questions about Terbutaline Turbuhaler

What is Terbutaline Turbuhaler used for?

Terbutaline Turbuhaler is a small molecule drug developed by AstraZeneca PLC for the treatment of asthma. It is administered via a dry powder inhaler device. The drug is currently in Phase 3 clinical development, meaning it is investigational and has not yet been approved for use.

Who makes Terbutaline Turbuhaler?

Terbutaline Turbuhaler is developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker AZN. The drug is being studied for the treatment of asthma and is currently in Phase 3 clinical trials.

What phase is Terbutaline Turbuhaler in?

Terbutaline Turbuhaler is in Phase 3 clinical development for the treatment of asthma. It is an investigational drug, meaning it has not yet received regulatory approval. Two Phase 3 trials have been completed, with a total of 124 participants enrolled across multiple countries.

What clinical trials is Terbutaline Turbuhaler in?

Terbutaline Turbuhaler has been studied in two completed Phase 3 trials. NCT00244608 compared asthma control with Symbicort Turbuhaler versus Symbicort Turbuhaler plus Pulmicort Turbuhaler plus Terbutaline Turbuhaler, enrolling 100 adults. NCT01096017 investigated the relative efficacy of Terbutaline Turbuhaler versus salbutamol pMDI in 24 participants.

Is Terbutaline Turbuhaler the same as Symbicort Turbuhaler?

Terbutaline Turbuhaler is not the same as Symbicort Turbuhaler. Symbicort is a combination product containing budesonide and formoterol, while Terbutaline Turbuhaler contains only terbutaline. In clinical trial NCT00244608, the two were studied together, with Symbicort used alone or in combination with Pulmicort and Terbutaline.