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formoterol

Phase 3

Asthma | Small molecule | Respiratory |Novartis AG|Last Updated: May 19, 2023

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials2
Total Enrollment205

FDA Designations

No designations recorded

Clinical trial landscape

formoterol · 2 trials · 1 indication

Phase 3 1Phase 2 1
NCT00130351A 3-week Study Investigating Patient Use and Functionality of Formoterol in a Novel Inhalation Device in Patients With AsthmaAsthma
COMPLETED155 Analytics
PHASE3COMPLETED
A 3-week Study Investigating Patient Use and Functionality of Formoterol in a Novel Inhalation Device in Patients With Asthma
AsthmaUnlock trial analytics

Study Endpoints

Primary Endpoints

Device use: Patients were instructed to record the number appearing in the dose counter window after their dose on the diary card.
Safety: Assessed by adverse events, physical examinations, vital signs abnormalities, forced expiratory volume in 1 second (FEV1) and screening ECG.
• Efficacy assessed by 12 hour Area Under the Curve (AUC) of FEV1 (forced expiratory volume in 1 second, is a measure of how well the lungs are working)

Secondary Endpoints

• Efficacy assessed by forced expiratory volume in 1 second at pre-dose, 15, 30 minutes, 1, 2, 3, 4, 6, 8, 10, 11 and 12 hours post dose
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeOTHER

Interventions

NameTypeDescription
formoterolDEVICE -
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Eligibility Criteria

Age Range5 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites12

Inclusion Criteria: * Patients who are capable of understanding the directions for device usage, evaluating device function and completing the patient diary * Patients who have a current diagnosis of asthma * Patients who have a documented forced expiratory volume at 1 second (FEV1) reversibility o...

Countries:United StatesGermany
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Frequently asked questions about formoterol

What is formoterol used for in asthma?

Formoterol is an investigational small molecule being studied for the treatment of asthma. It is a bronchodilator intended to help manage asthma symptoms. The drug is currently in clinical development, with completed trials evaluating its use in patients with asthma, including studies on device functionality and dose equivalence.

Who makes formoterol?

Formoterol is being developed by Novartis AG, a global healthcare company traded on the New York Stock Exchange under the ticker symbol NVS. The company has conducted clinical trials to evaluate the drug's use in asthma, including studies on inhalation devices and dose equivalence.

What phase is formoterol in?

Formoterol is in Phase 3 clinical development for asthma. While one trial is listed as Phase 3, another is Phase 2. The drug is investigational and has not been approved by regulatory authorities. All completed trials have finished, and no active trials are currently listed.

What clinical trials is formoterol in?

Formoterol has been studied in two completed clinical trials. NCT00130351 was a Phase 3 study in the United States with 155 participants, examining patient use and functionality of formoterol in a novel inhalation device for asthma. NCT00443482 was a Phase 2 study in Germany with 50 participants, demonstrating equivalence of formoterol 12 and 24 µg delivered via two dry powder inhalers.

Is formoterol the same as other asthma medications?

Formoterol is a specific drug being developed by Novartis. It is a long-acting bronchodilator used in asthma treatment. While it belongs to a class of medications known as beta-2 agonists, the data provided does not list alternative names for this specific drug. It is being studied for its efficacy and device compatibility in asthma patients.