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AER 001 Nebulization in Atopic Asthma
NCT00535431Phase 2
Key facts
- Status
- Completed
- Start
- Dec 2005
- Countries
- 1
- Sponsor
- Aerovance
- Modality
- rProtein (Recombinant Protein), Biologic
- Drugs
- pitrakinra
- Conditions
- allergic asthma
01
Overview
Phase 2, randomised, double-blind trial in allergic asthma comparing AER 001 with Placebo (2 arms). Primary endpoint: Average percent change in FEV1 from 4-10 hours following allergen challenge at 28 days. Started Dec 2005; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
AER 001
Pitrakinra 60 mg nebulized BID
Placebo
Sterile saline nebulized BID
03
Who it enrols
Adults with allergic asthma, FEV1 > 70%, positive skin prick test, and demonstrated late phase response to allergen challenge. Excludes smokers, recent steroid use, and significant other medical conditions.
04
Endpoints
Primary
Average percent change in FEV1 from 4-10 hours following allergen challenge
Secondary
Antigen induced airway hyperactivity to adenosine monophosphate
Blood levels of circulating IgE
Pharmacokinetics of nebulised AER 001
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