Clinical Trials
AeroLEF® met all endpoints in a randomized Phase II trial and is currently being prepared for late-stage development internationally.
For details about clinical trials with AeroLEF, move your mouse over the indications below.
Indication |
Phase I |
Phase II |
Phase III |
Publications |
Acute PainAeroLEF vs. placebo, multi-dose, post-operative, Phase IIb
Status: Complete
Phase: IIB
Regimen: AeroLEF vs. placebo
Study Design: 2-part, multi-dose, post-op, open-label, prospective, randomized, double-blind, placebo-controlled
Primary Endpoint: Efficacy
# Patients: 120
Trial Location: Canada
Results: (Part 1) Reported mild or no pain: AeroLEF 59%, placebo 27%; (Part 2) Effective analgesia: AeroLEF 65%, placebo 35%
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Acute Paindose-to-effect, single dose, post-operative, Phase IIa
Status: Complete
Phase: IIA
Regimen: AeroLEF
Study Design: Dose-to-effect, single dose, post-op, open-label
Primary Endpoints: Safety and efficacy
# Patients: 19
Trial Location: Canada
Results: Decrease in pain intensity: 18 of 19 pts (95%); Effective analgesia >2 hrs: 56%; Effective analgesia >3 hrs: 39%; Mean duration of effective analgesia: 221 min; Well-tolerated; No serious AEs reported
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Status: Complete
Phase: IB
Trial Location: Canada
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Pharmacokinetic Studysingle and multi-dose
Status: Complete
Phase: I
Study Design: single and multi-dose
Trial Location: Canada
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Status: Complete
Phase: I
Regimen: AeroLEF vs. Bolus IV fentanyl
Study Design: 2-arm, single dose
Primary Endpoints: Pharmacokinetics, safety and tolerability
# Patients: 10
Trial Location: Canada
Results: Majority of pts achieved Cmax in <10 min; AeroLEF maintained Cfen for >4 hrs, 4 times longer than IV fentanyl; Safety, tolerability and preservation of pulmonary function comparable to IV fentanyl
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completed study |
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ongoing study |
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multi-phase study |
