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Formoterol in the Pressair DPI, Low Dose · 1 trial · 1 indication
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
| Arm | Type | Description |
|---|---|---|
| Experimental 1 | EXPERIMENTAL | Formoterol Fumarate in the Pressair Pressair Dry Powder Inhaler (DPI), Low Dose |
| Experimental 2 | EXPERIMENTAL | Formoterol fumarate in the Pressair Dry Powder Inhaler (DPI), High Dose |
| Active Comparator 1 | ACTIVE_COMPARATOR | Foradil Aerolizer, Low Dose |
| Active Comparator 2 | ACTIVE_COMPARATOR | Foradil Aerolizer, High Dose |
| Placebo | PLACEBO_COMPARATOR | Dose matched placebo |
| Name | Type | Description |
|---|---|---|
| Formoterol Fumarate in the Pressair DPI, Low Dose | DRUG | Formoterol Fumarate in the Pressair DPI 6 micrograms, twice a day for 14 days |
| Formoterol Fumarate in the Pressair DPI, High Dose | DRUG | Formoterol Fumarate in the Pressair DPI 12 micrograms, twice a day for 14 days |
| Foradil Aerolizer, Low Dose | DRUG | Foradil Aerolizer 12 micrograms, twice a day for 14 days |
| Foradil Aerolizer, High Dose | DRUG | Foradil Aerolizer 24 micrograms, twice per day for 14 days |
| Placebo | DRUG | Placebo in the Pressair for 14 days |
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...
Formoterol in the Pressair DPI, Low Dose is an investigational small molecule being developed for the treatment of asthma. It is a low-dose formulation of formoterol delivered via the Pressair dry powder inhaler. The drug is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
Formoterol in the Pressair DPI, Low Dose is a long-acting beta-agonist that works by relaxing the muscles in the airways, which helps to open the airways and improve breathing in patients with asthma. It is delivered via the Pressair dry powder inhaler device.
Formoterol in the Pressair DPI, Low Dose is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the safety and efficacy of this drug for the treatment of asthma.
Formoterol in the Pressair DPI, Low Dose is in Phase 2 clinical development. It is an investigational drug and has not yet been approved by the FDA or any other regulatory agency. The drug is being studied for the treatment of asthma in adult patients.
Formoterol in the Pressair DPI, Low Dose has been studied in one completed Phase 2 clinical trial, identified as NCT01641081. This randomized, double-blind, placebo-controlled trial enrolled 174 adult patients with mild to moderate asthma in the United States to compare the drug to another formoterol product.
Formoterol in the Pressair DPI, Low Dose is a formulation of formoterol fumarate delivered via the Pressair dry powder inhaler. It is being studied in comparison to Foradil Aerolizer, which is another formoterol product. While both contain formoterol, they are different formulations and delivery devices.