This study will compare the rate and extent of absorption of TI Inhalation Powder in subjects with asthma and subjects with normal lung function. 24 eligible subjects will be enrolled into the treatment phase of the trial.
Visit 1 screening will determine eligibility and obtain informed consent. At visit 2, 3 and 4 subjects inhale 1 dose of 45U TI Inhalation Powder. At visit 3 subjects inhale 2 puffs (200mcg) Albuterol prior to dosing. Only asthmatic subjects undergo visit 4 where a methacholine challenge test (MCT) is performed followed by inhalation of Albuterol then administration of TI Inhalation Powder. Each visit's dosing will occur during a hyperinsulinemic euglycemic clamp. Visit 5 is the follow up visit.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
3.0 of human insulin. single dose cartridges filled with 5 or 10 mg of Technosphere Inhalation Powder, containing 15 or 30 u of insulin
2 puff = 200 mcg total dose
5mls of methacholine; diluent sodium chloride 0.9%; formulation methacholine chloride in sodium chloride 0.9%
Medicines Evaluation Unit (MEU)
Manchester, England, United Kingdom
ICON Development Solutions
Manchester, United Kingdom
AUCF 0-360 min of serum insulin
Time frame: 0-360 min
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