Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Formoterol Turbuhaler · 5 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.
Number of COPD-related exacerbations per patient-treatment year. COPD-related exacerbation was defined as worsening COPD that required a course of oral steriods for treatment and/or hospitalization.
Rate of exacerbations per subject-year
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 |
| Budesonide/formoterol (SYMBICORT) pMDI | DRUG | - |
| Formoterol Turbuhaler | DRUG | - |
| Budesonide/formoterol pMDI | DRUG | - |
| Budesonide pMDI | DRUG | - |
| 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 a small molecule respiratory drug developed by AstraZeneca for use in Chronic Obstructive Pulmonary Disease (COPD). It has been studied in clinical trials as a bronchodilator treatment for COPD patients, including comparisons against placebo and other combination therapies. The drug is administered via a dry powder inhaler device.
Formoterol Turbuhaler is developed by AstraZeneca PLC, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol AZN. AstraZeneca has conducted multiple clinical trials evaluating the drug in patients with Chronic Obstructive Pulmonary Disease.
Formoterol Turbuhaler has completed Phase 3 clinical trials for Chronic Obstructive Pulmonary Disease, with four total trials completed and no active trials currently ongoing. The drug remains investigational and is not approved for commercial use based on the available clinical trial data.
Formoterol Turbuhaler has been studied in four completed clinical trials with a total enrollment of 4,913 patients. Key trials include NCT00206154, NCT00206167, and NCT00419744, all Phase 3 studies in COPD patients, and NCT01257048, an early Phase 1 study evaluating an imaging method in COPD.
Formoterol Turbuhaler is not the same as Symbicort, though both are developed by AstraZeneca. Symbicort is a combination product containing both budesonide and formoterol, while Formoterol Turbuhaler contains only formoterol as a single agent. Clinical trials have directly compared the two treatments in COPD patients.
Formoterol Turbuhaler contains formoterol, a long-acting beta2-adrenergic receptor agonist that works by relaxing airway smooth muscle to produce bronchodilation. The drug targets beta2-adrenergic receptors in the lungs, which helps to open airways and improve breathing in patients with Chronic Obstructive Pulmonary Disease.