Recent Updates
Recently added Catalysts

Formoterol in the Pressair DPI, Low Dose

Phase 2

Asthma | Small molecule | Respiratory |AstraZeneca PLC|Last Updated: Feb 28, 2017

Target and mechanism

Molecular targetADRB2
Target classAgonist
ModalitySmall molecule

Also known as Formoterol Fumarate in the Pressair DPI, Low Dose

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment174

FDA Designations

No designations recorded

Clinical trial landscape

Formoterol in the Pressair DPI, Low Dose · 1 trial · 1 indication

Phase 2 1
NCT01641081Efficacy and Safety Study to Compare Formoterol Fumerate in the Pressair DPI to the Foradil Aerolizer in Patient With Mild to Moderate AsthmaAsthma
COMPLETED174 Analytics
PHASE2COMPLETED
Efficacy and Safety Study to Compare Formoterol Fumerate in the Pressair DPI to the Foradil Aerolizer in Patient With Mild to Moderate Asthma
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Normalized Forced Expiratory Volume in One Second (FEV1) AUC0-6 After the Morning Dose (Day 14)
Baseline and up to 6 hrs post-dose (±15 min) on Day 14 of treatment

AUC0-6 is area under the curve from time 0 to 6 hours Serial spirometry was performed at -60 min predose, at 5 (+5) and 30 (±5) min post-dose, and at 1, 2, 3, 4, and 6 hrs post-dose (±15 min) Change from baseline was baseline of each treatment period The normalized FEV1 AUC0-6 was calculated by means of the trapezoidal method, dividing the area under the curve by the corresponding time intervals

Secondary Endpoints

Change From Baseline in Normalized FEV1 AUC0-6 After the Morning Dose (Day 1)
Baseline and up to 6 hrs post-dose (±15 min) on Day 1 of treatment
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Experimental 1EXPERIMENTALFormoterol Fumarate in the Pressair Pressair Dry Powder Inhaler (DPI), Low Dose
Experimental 2EXPERIMENTALFormoterol fumarate in the Pressair Dry Powder Inhaler (DPI), High Dose
Active Comparator 1ACTIVE_COMPARATORForadil Aerolizer, Low Dose
Active Comparator 2ACTIVE_COMPARATORForadil Aerolizer, High Dose
PlaceboPLACEBO_COMPARATORDose matched placebo

Interventions

NameTypeDescription
Formoterol Fumarate in the Pressair DPI, Low DoseDRUGFormoterol Fumarate in the Pressair DPI 6 micrograms, twice a day for 14 days
Formoterol Fumarate in the Pressair DPI, High DoseDRUGFormoterol Fumarate in the Pressair DPI 12 micrograms, twice a day for 14 days
Foradil Aerolizer, Low DoseDRUGForadil Aerolizer 12 micrograms, twice a day for 14 days
Foradil Aerolizer, High DoseDRUGForadil Aerolizer 24 micrograms, twice per day for 14 days
PlaceboDRUGPlacebo in the Pressair for 14 days
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites29

Inclusions: * Patients with mild-to-moderate asthma for at least 6 months prior to Visit 1 (as defined in the GINA Guidelines) which is unlikely to exacerbate during the study (e.g., due to seasonal allergen exposure). * Patients must be on a stable dose of Inhaled Corticosteroids (ICS) for at leas...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about Formoterol in the Pressair DPI, Low Dose

What is formoterol in the Pressair DPI, low dose?

Formoterol in the Pressair DPI, low dose is an investigational small molecule therapy being developed by AstraZeneca PLC for asthma. It delivers a low dose of formoterol fumarate through the Pressair dry powder inhaler. It is in Phase 2 clinical development and is not approved for commercial use.

What is formoterol in the Pressair DPI, low dose used for?

Formoterol in the Pressair DPI, low dose is being studied for the treatment of asthma in adults. The Phase 2 program enrolled patients aged 18 years and older with mild to moderate asthma. The drug remains investigational and has not been approved for any indication.

What does formoterol in the Pressair DPI, low dose target?

Formoterol in the Pressair DPI, low dose targets ADRB2, the beta-2 adrenergic receptor. It acts as an agonist at this receptor. This is the same receptor class targeted by other long-acting beta-2 agonist bronchodilators used in respiratory medicine.

Who makes formoterol in the Pressair DPI, low dose?

AstraZeneca PLC, which trades under the ticker AZN, is the developer of formoterol in the Pressair DPI, low dose. The company is responsible for the clinical development program evaluating this low-dose formoterol fumarate formulation delivered via the Pressair dry powder inhaler.

What phase is formoterol in the Pressair DPI, low dose in?

Formoterol in the Pressair DPI, low dose is in Phase 2 clinical development. The single completed trial was a Phase 2 study. The drug is investigational and has not received FDA approval. No active trials are currently listed for this asset.

What clinical trials is formoterol in the Pressair DPI, low dose in?

Formoterol in the Pressair DPI, low dose was evaluated in NCT01641081, a completed Phase 2 study comparing formoterol fumarate in the Pressair DPI to the Foradil Aerolizer in patients with mild to moderate asthma. The trial enrolled 174 participants in the United States and was randomized, double-blind, and placebo-controlled.

Is formoterol in the Pressair DPI, low dose the same as formoterol fumarate in the Pressair DPI, low dose?

Yes. Formoterol in the Pressair DPI, low dose is also known as formoterol fumarate in the Pressair DPI, low dose. Both names refer to the same AstraZeneca Phase 2 asthma asset, a low-dose formoterol fumarate formulation delivered through the Pressair dry powder inhaler.