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formoterol

Phase 3

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials2
Total Enrollment205
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00130351A 3-week Study Investigating Patient Use and Functionality of Formoterol in a Novel Inhalation Device in Patients With AsthmaPHASE3 COMPLETED 155Jul 1, 2005Aug 1, 2005May 19, 202312 United States
NCT00443482Study to Demonstrate Equivalence of Formoterol 12 and 24 µg Delivered Via Two Types of Single Dose Dry Powder Inhalers (Concept1 and Aerolizer)PHASE2 COMPLETED 50Feb 1, 2007May 1, 2007Mar 28, 20174 Germany
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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 — 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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