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Formoterol

Phase 4FDA approved

Asthma | Small molecule | Respiratory |AstraZeneca PLC|Trials Updated: Feb 7, 2018

Formoterol development status

FDA approval on record Feb 16, 2001
Approval holderNovartis
ApplicationNDA020831
Highest phase Phase 4 (NCT00561886)
Phase scored for AZNPhase 3
Registered trials 23 across 7 sponsors since Aug 2005

Formoterol target and mechanism

Molecular targetADRB2
Target classAgonist
ModalitySmall molecule

Also known as Formoterol Fumarate, Formoterol (Oxis Turbuhaler), Formoterol (OT), Formoterol (Pressair®), Perforomist® Inhalation Solution

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials4
Total Enrollment508

FDA Designations

No designations recorded

Formoterol clinical trials

Formoterol · 4 trials · 3 indications

Phase 3 2Phase 2 2
NCT01047553Study to Evaluate the Safety and Efficacy of Formoterol in a Daily Dose of 18 µg (9 µg Twice Daily) in Japanese Chronic Obstructive Pulmonary Disease (COPD) PatientsChronic Obstructive Pulmonary Disease
COMPLETED251 Analytics
NCT00288379SMILDA - Symbicort®Turbuhaler® Allergan Challenge Study in Allergic Patients With Mild AsthmaAsthma
COMPLETED16 Analytics
PHASE3COMPLETED
Study to Evaluate the Safety and Efficacy of Formoterol in a Daily Dose of 18 µg (9 µg Twice Daily) in Japanese Chronic Obstructive Pulmonary Disease (COPD) Patients
Chronic Obstructive Pulmonary DiseaseUnlock trial analytics
PHASE3COMPLETED
SMILDA - Symbicort®Turbuhaler® Allergan Challenge Study in Allergic Patients With Mild Asthma
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

Clinical Laboratory Test: Haematology -Erythrocytes
Baseline and week 52

Mean change from Baseline

Clinical Laboratory Test: Haematology -Haemoglobin
Baseline and week 52

Change from baseline

Clinical Laboratory Test: Haematology-Leucocytes
Baseline and week 52

Change from baseline

Clinical Laboratory Test: Haematology-Platelet Count
Baseline and week 52

Change from baseline

Clinical Laboratory Test: Haematology Eosinophils
baseline and week 52

Change from baseline

Clinical Laboratory Test: Haematology Basophil
Baseline and week 52

Change from baseline

Clinical Laboratory Test: Haematology-Lymphocytes
Baseline and week 52

Change from baseline

Clinical Laboratory Test: Haematology-Monocytes
Baseline and week 52

Change from baseline

Clinical Laboratory Test: Haematology -Neutrophils
Baseline and week 52

Change from baseline

Clinical Laboratory Test: Clinical Chemistry- S-Alanine Aminotransferase
Baseline and week 52

Change from baseline

Clinical Laboratory Test: Clinical Chemistry-S-Aspartate Aminotransferase
Baseline and week 52

Change from baseline

Clinical Laboratory Test: Clinical Chemistry-S-Alkaline Phosphatase (ALP)
Baseline and week 52

Change from baseline

Clinical Laboratory Test: Clinical Chemistry-S-Creatinine
Baseline and week 52

Change from Baseline

Clinical Laboratory Test: Clinical Chemistry-S-Total Bilirubin
Baseline and week 52

Change from baseline

Clinical Laboratory Test: Clinical Chemistry-S-Sodium
Baseline and week 52

Change from baseline

Clinical Laboratory Test: Clinical Chemistry-S-Potassium
Baseline and week 52

Change from baseline

Clinical Laboratory Test: Clinical Chemistry-S- Calcium
Baseline and week 52

Change from baseline

Clinical Laboratory Test: Clinical Chemistry-S-Albumin
Baseline and week 52

Change from baseline

Clinical Laboratory Test: Clinical Chemistry-S-Total Protein
Baseline and week 52

Change from baseline

Clinical Laboratory Test: Clinical Chemistry - S-Blood Urea Nitrogen (BUN)
Baseline and week 52

Change from baseline

Vital Signs- Sitting SBP
Baseline and week 52

Change from baseline

Vital Signs- Sitting DBP
Baseline and week 52

Change from baseline

Vital Signs - Pulse Rate
Baseline and week 52

Change from baseline

ECG Variables - Heart Rate
Baseline and week 52

Change from baseline

ECG Variables - QT Interval
Baseline and week 52

Change from baseline

ECG Variables - QTcB Interval
Baseline and week 52

Change from baseline

ECG Variables QTcF Interval
Baseline and week 52

Change from baseline

ECG Variables RR Interval
Baseline and week 52

Change from baseline

PD20 methacholine (measured as the change using the measurement before and after each treatment period).
Change From Baseline in Normalized Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve (AUC) Over the 12 h Period Immediately After Morning Study Drug Administration, AUC0-12/12h at Day 7 on Treatment
Day 7: 30 min, 1 to 4 hours, 6 hours, 9 hours and 12 hours post-dose

To assess the bronchodilation of 3 doses of formoterol fumarate (6 μg, 12 μg and 24 μg) twice daily (BID administered via Pressair® compared to placebo and to open-label nebulised formoterol fumarate(20 μg). Pre-dose spirometry was performed before the morning daily dose at Day 1 and Day 7 of each treatment period. Two sets of measurements were performed during the hour preceding the scheduled morning study drug administration, allowing approximately 30 minutes between them. Note: Perforomist® 40 μg treatment periods lasted for 1 day only. Hence, was not included in the calculation.

FEV1(Forced Expiratory Volume in 1 Second) Measured by Spirometry 5 Minutes Post Dose
Pre-dose and 5 minutes post-dose

FEV1(Forced Expiratory Volume in 1 second) measured by spirometry 5 minutes post dose, percentage change versus pre dose FEV1

Secondary Endpoints

Forced Expiratory Volume in One Second (FEV1)
Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization
Forced Vital Capacity (FVC)
Before randomization, 0, 4, 8, 17, 26, 34, 43 and 52 weeks after randomization
Morning Peak Expiratory Flow(PEF)
Daily during run-in period (14 - 18 days before Randomisation visit)and daily during 52-week randomization treatment
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALFormoterol 9 μg/dose
Formoterol 6 μgEXPERIMENTALParticipants received formoterol fumarate 6 μg administered via Pressair twice daily (BID).
Formoterol 12 μgEXPERIMENTALParticipants received formoterol fumarate 12 μg administered via Pressair BID.
Formoterol 24 μgEXPERIMENTALParticipants received formoterol fumarate 24 μg administered via Pressair BID.
PlaceboPLACEBO_COMPARATORParticipants received placebo to formoterol fumarate administered via Pressair BID.
Formoterol 20 μgEXPERIMENTALParticipants received Perforomist inhalation solution and were instructed to take one puff from each of the two Pressair inhalers or to inhale one vial from the Perforomist 20 μg inhalation solution BID for 7 ± 1 consecutive days.
Formoterol 40 μgEXPERIMENTALParticipants received Perforomist 40 μg (2 vials of Performist 20 μg) as a single dose of administration.
Formoterol, then Salmeterol, then PlaceboEXPERIMENTALFormoterol Turbuhaler 9 μg and Placebo Diskus first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Placebo Diskus and Placebo Turbuhaler
Salmeterol, then Palcebo, then FormoterolEXPERIMENTALSalmeterol Diskus 50 μg and Placebo Turbuhaler first, then Placebo Diskus and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus
Placebo, then Formoterol, then SalmeterolEXPERIMENTALPlacebo Diskus and Placebo Turbuhaler first,then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Salmeterol Diskus 50 μg and Placebo Turbuhaler
Formoterol, then Placebo, then SalmeterolEXPERIMENTALFormoterol Turbuhaler 9 μg and Placebo Diskus first, then Placebo Diskus and Placebo Turbuhaler, then Salmeterol Diskus 50 μg and Placebo Turbuhaler
Salmeterol, then Formoterol, then PlaceboEXPERIMENTALSalmeterol Diskus 50 μg and Placebo Turbuhaler first, then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Placebo Diskus and Placebo Turbuhaler
Placebo, then Salmeterol, then FormoterolEXPERIMENTALPlacebo Diskus and Placebo Turbuhaler first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus

Interventions

NameTypeDescription
Formoterol (OT)DRUG9 μg/dose, Inhaled, twice daily for 52 weeks
formoterolDRUG -
budesonide/formoterolDRUG -
Formoterol fumarate (6 μg)DRUGOral Inhalation (by Pressair® Dry Powder Inhaler, DPI)
Formoterol furmarate (20 μg)DRUGOral Inhalation (via a standard jet nebulizer connected to an air compressor.
Placebo for formoterol fumarateDRUGOral Inhalation (by Pressair® Dry Powder Inhaler, DPI)
Formoterol fumarate (12 μg)DRUGOral Inhalation (by Pressair® Dry Powder Inhaler, DPI)
Formoterol fumarate (40 μg)DRUGOral Inhalation (via a standard jet nebulizer connected to an air compressor.
SalmeterolDRUGSalmeterol Diskus 50 μg and Placebo Turbuhaler
PlaceboDRUGPlacebo Diskus and Placebo Turbuhaler
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Eligibility Criteria

Age Range40 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites27

Inclusion Criteria: * Outpatients, men or women ≥ 40 years * A clinical diagnosis of COPD according to guidelines, and current COPD symptoms. * Post-bronchodilator FEV1 \< 80% of predicted normal value and FEV1/FVC \< 70%, post-bronchodilator Exclusion Criteria: * A history and/or current clinica...

Countries:JapanSwedenUnited StatesItalySpain
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Frequently asked questions about Formoterol

What is Formoterol used for?

Formoterol is used to treat asthma and chronic obstructive pulmonary disease, or COPD. It is a long-acting inhaled bronchodilator developed by AstraZeneca PLC. In COPD it helps keep the airways open, and in asthma it is studied as part of inhaled treatment regimens. It is given by inhalation through devices such as the Turbuhaler.

How does Formoterol work?

Formoterol works as an agonist at ADRB2, the beta-2 adrenergic receptor. By activating this receptor on airway smooth muscle, it produces bronchodilation and helps relieve airflow obstruction in asthma and COPD. This receptor target class, a beta-2 agonist, is the basis for its use as a long-acting bronchodilator in respiratory disease.

Who makes Formoterol?

Formoterol is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca has run clinical studies of the drug in asthma and COPD, including the ACHIEVE Duaklir USA Phase IIb dose ranging study and the SMILDA study in allergic asthma patients.

What phase is Formoterol in?

Formoterol has been studied in Phase 3 clinical development for asthma and COPD. Completed Phase 3 trials include NCT01047553, which evaluated an 18 microgram daily dose in Japanese COPD patients, and NCT00288379, the SMILDA study in allergic patients with mild asthma. It remains an investigational asset in these programs.

What clinical trials is Formoterol in?

Formoterol has completed clinical trials including NCT02796651, a Phase 2 dose ranging study in COPD in the United States; NCT01048333, a Phase 2 onset of effect study in COPD in Italy, Spain and Sweden; NCT01047553, a Phase 3 COPD study in Japan; and NCT00288379, a Phase 3 asthma study in Sweden.

Is Formoterol the same as Formoterol fumarate?

Yes. Formoterol is also known as formoterol fumarate, formoterol fumarate 6 microgram, and Formoterol (Oxis Turbuhaler) or Formoterol (OT). These names refer to the same active drug and its inhaled Turbuhaler formulation, so searches for any of these terms describe the same AstraZeneca respiratory asset.