Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Formoterol Turbuhaler · 2 trials · 3 indications
FEV1 (expressed as litres \[L\]) is a spirometric measure of lung function. FEV1 was measured 60 minutes after administration of study drug. The results are expressed as a percentage in relation to the baseline value.
Oxygen enhanced magnetic resonance imaging (OE-MRI) parameters
Oxygen enhanced MRI parameters
Oxygen enhanced MRI parameters
| Arm | Type | Description |
|---|---|---|
| F 4.5 bid | EXPERIMENTAL | Formoterol 4.5 ug twice daily (bid) |
| F 9.0 bid | EXPERIMENTAL | Formoterol 9.0 ug bid |
| PBO | PLACEBO_COMPARATOR | Placebo |
| 1 | PLACEBO_COMPARATOR | Single Dose evaluation placebo (V5) |
| 2 | ACTIVE_COMPARATOR | Single Dose evaluation formoterol (V5) |
| Name | Type | Description |
|---|---|---|
| Formoterol Turbuhaler® 4.5mg | DRUG | 4.5 mg inhaled twice daily |
| Formoterol Turbuhaler® 9 mg | DRUG | 9 mg inhaled twice daily |
| Turbuhaler® placebo | DRUG | placebo inhaled twice daily |
| Formoterol Turbuhaler | DRUG | 9 microgram on visit 5 single dose |
| Budesonide/Formoterol Turbuhaler | DRUG | 320/9 microgram twice daily during 8 weeks |
Inclusion Criteria: * Males or females aged above 40 with a clinical diagnosis of COPD and current COPD symptoms * Current or previous smoker with a smoking history of 10 or more pack years * Lung function parameters: FEV1/FVC \< 70%, post-bronchodilator and post-bronchodilator FEV1 \< 80% of predi...
Formoterol Turbuhaler is an inhaled small molecule therapy developed by AstraZeneca PLC (ticker AZN) for chronic obstructive pulmonary disease (COPD). It is delivered through the Turbuhaler dry powder inhaler device and is also written as Formoterol Turbuhaler 4.5mg. It is being studied in COPD method evaluation and in COPD itself.
Formoterol Turbuhaler is used for chronic obstructive pulmonary disease, a respiratory condition. It has been studied in COPD method evaluation as well as in COPD treatment settings. Clinical work includes patients aged 40 years and older in Japan, Europe, and other regions.
Formoterol Turbuhaler targets ADRB2, the beta-2 adrenergic receptor. It acts as an agonist at this receptor, meaning it activates the receptor. This target class places it among beta-2 agonist bronchodilator therapies used in respiratory medicine.
Formoterol Turbuhaler is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor associated with the clinical development program for this inhaled COPD therapy.
Formoterol Turbuhaler is in Phase 1 development. It is investigational and is not described as approved. The program includes one completed early Phase 1 trial and one completed Phase 3 trial, with no active trials currently listed.
Formoterol Turbuhaler has been studied in two completed trials. NCT01257048 was an early Phase 1 evaluation of an oxygen enhanced magnetic resonance imaging method in COPD patients during 8 weeks of treatment, enrolling 34 patients in Sweden and the United Kingdom. NCT00628862 was a Phase 3 efficacy and safety study versus placebo in Japan and Europe, enrolling 613 patients.