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SYMBICORT TURBOHALER

Phase 3

Asthma | Small molecule | Respiratory |Teva Pharmaceutical Industries Limited|Last Updated: Dec 8, 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-BlindACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment605
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01803555Efficacy and Safety Evaluation of Budesonide/Formoterol SPIROMAX® Inhalation Powder Versus SYMBICORT® TURBOHALER®PHASE3 COMPLETED 605Jul 4, 2013Mar 20, 2014Dec 8, 2023114 Austria, Belgium +14
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Study Endpoints
Primary Endpoints
Change From Baseline in Weekly Average of Daily Trough (Predose and Pre-rescue Bronchodilator) Morning (AM) Peak Expiratory Flow (PEF) Over the 12-Week Treatment Period
Baseline, Weeks 1 to 12 (averaged over 12 weeks)

PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Baseline trough morning PEF was defined as the average value of recorded (nonmissing) morning assessments 5 out of the last 7 days prior to randomization. The first day before randomization consisted of the electronic patient diary entry at home on the morning of the randomization visit (Baseline \[Day 1\]) and the first day postrandomization consisted of the electronic patient diary entry at home on the morning of the day after the randomization visit (Baseline \[Day 1\]). For postdose weekly average of trough morning PEF measurements, the values were the averages based on the available data for that week. The averages were calculated as the sum of morning PEF values divided by the number of nonmissing assessments. The final value for change from baseline was calculated as the average of the weekly change from baseline averaged over 12 weeks.

Secondary Endpoints
Change From Baseline in Weekly Average of Daily Evening (PM) PEF Over the 12-Week Treatment Period
Baseline, Weeks 1 to 12 (averaged over 12 weeks)
Number of Participants With Adverse Events (AEs)
Baseline up to Week 12
Number of Participants With Signs of Oral Candidiasis (Thrush)
Baseline, Week 4, Week 8, Week 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BF SpiromaxEXPERIMENTAL2 inhalations of BF Spiromax at a dosage of 160/4.5 mcg and 2 inhalations of SYMBICORT placebo administered twice daily (AM and PM) during the 12-week treatment period.
Symbicort TurbohalerACTIVE_COMPARATOR2 inhalations of SYMBICORT TURBOHALER at a dosage of 200/6 mcg and 2 inhalations of placebo SPIROMAX administered twice daily (AM and PM) during the 12-week treatment period.
Interventions
NameTypeDescription
Budesonide/Formoterol SPIROMAX®DRUGBF Spiromax will be administered per dose and schedule specified in the arm.
SYMBICORT® TURBOHALER®DRUGSymbicort Turbohaler will be administered per dose and schedule specified in the arm.
SYMBICORT placeboDRUGSYMBICORT placebo multi-dose dry powder inhaler (DPI) identical in appearance to SYMBICORT TURBOHALER will be administered per dose and schedule specified in the arm.
SPIROMAX PlaceboDRUGSPIROMAX Placebo multi-dose dry powder inhaler (DPI) identical in appearance to BF SPIROMAX will be administered per dose and schedule specified in the arm.
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Eligibility Criteria
Age Range12 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites114

Inclusion Criteria: * Male or female participants 12 years and older as of the screening visit. Male or female participants 18 years and older, as of the screening visit, in countries where local regulations or the regulatory status of study medication permit enrollment of adult participants only. ...

Countries:AustriaBelgiumCzechiaDenmarkFinlandFranceGermanyHungaryIsraelItalyNetherlandsPolandRussiaSpainSwedenUnited Kingdom
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