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Albuterol HFA-BOI

Phase 2

Asthma | Small molecule | Respiratory |Teva Pharmaceutical Industries Limited|Last Updated: Nov 30, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment14

FDA Designations

No designations recorded

Clinical trial landscape

Albuterol HFA-BOI · 1 trial · 1 indication

Phase 2 1
NCT00054964Comparative Effectiveness of a Breath-operated Albuterol Inhaler in Asthma Patients With Poor Inhaler TechniqueAsthma
COMPLETED14 Analytics
PHASE2COMPLETED
Comparative Effectiveness of a Breath-operated Albuterol Inhaler in Asthma Patients With Poor Inhaler Technique
Asthma
NCT0005496414
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Study Endpoints

Primary Endpoints

Percent change in SGaw (A measure of the change in specific airway conductance - how hard it is to get air into the lungs)
Pre-dose and +120 minutes

Secondary Endpoints

The area-under-the-effect curve of change in SGaw from basline over time
Pre-dose and +120 minutes
The maximum increase in SGaw from baseline over two hours
Baseline through +120 minutes
Time in hours to the maximum increase in SGaw from baseline
Baseline through +120 minutes post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Albuterol HFA-BOIEXPERIMENTAL -
Albuterol HFA-MDIACTIVE_COMPARATOR -

Interventions

NameTypeDescription
Albuterol HFA-BOIDRUGAlbuterol HFA breath operated inhaler, 90 mcg/sprau
Albuterol HFA-MDIDRUGAlbuterol HFA multi-dose inhaler
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Asthma diagnosed ≥6 months prior and stable for 4 weeks prior to screening * Poor inhaler coordination as assessed at screening * Reversible bronchoconstriction (≥ 12% increase in FEV1) Exclusion Criteria: * Albuterol allergy * Investigational drug within 30 days * Injected ...

Countries:United States
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Competitive Landscape -Asthma 75 trials

CompanyTickerTrialsLead PhaseDrugs
Teva Pharmaceutical Industries Limited Sponsored ADRTEVA4PHASE3Fp/ABS, ABS
Novartis AG Sponsored ADRNVS5PHASE3QVM149, Salmeterol Xinafoate/ Fluticasone Propionate
GSK plc Sponsored ADRGSK5PHASE3FF/UMEC/VI
Sanofi SA Sponsored ADRSNY7PHASE3Dupilumab
AstraZeneca PLCAZN26PHASE3Benralizumab
Generate Biomedicines, Inc.GENB3PHASE3GB-0895
Eli Lilly and CompanyLLY1PHASE2Brenipatide
Incyte CorporationINCY1PHASE2povorcitinib, ICS-LABA
Pfizer Inc.PFE1PHASE2PF-07275315
Kymera Therapeutics, Inc.KYMR1PHASE2KT-621
Arrowhead Pharmaceuticals, Inc.ARWR1PHASE2ARO-RAGE
Upstream Bio, Inc.UPB1PHASE2Verekitug
Sunshine Biopharma IncorporatedSBFM2PHASE3610
Amgen Inc.AMGN1PHASE1AMG 691
Apogee Therapeutics, Inc.APGE1PHASE1APG777
Celldex Therapeutics, Inc.CLDX1PHASE1CDX-622
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