evaluate safety of technosphere® insulin (ti) in diabetic subjects with moderate obstructive pulmonary disease

Conditions: Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus; Moderate Chronic Obstructive Pulmonary Disease; Asthma

Summary: examine the effects of ti in combination with an anti-diabetic regimen including inhaled insulin versus anti-diabetic treatment without inhaled insulin on lung function \& pulmonary safety


Eligibility criteria:
inclusion criteria: asthma * physician diagnosis of asthma with history of any or all of the following: recurrent wheezing, recurrent chest tightness, recurrent difficulty breathing, or cough, particularly worse at nighttime * never smoked or former smokers (= 6 months since cessation) * ≥18 years of age * prebronchodilator forced expiratory volume in 1sec (fev1) ≥ 60% third national health and nutrition examination survey (nhanes iii) predicted, prebronchodilator total lung capacity (tlc) ≥ 80% predicted intermountain thoracic society (its), and prebronchodilator single breath carbon monoxide diffusing capacity of the lung (dlco) (unc) ≥70% predicted (miller) * \< 30% day-to-day variability in daily morning peak expiratory volume (pef) during the 2-week run-in period * significant improvement in pre- to postbronchodilator spirometry (defined as an increase from baseline of ≥ 12% and ≥ 200 ml in fev1 or forced vital capacity \[fvc\]) at screening/visit 1 or documented significant improvement in pre- to postbronchodilator spirometry (as defined above) within past 12 months in subject's medical records or a documented positive methacholine challenge test within the past 12 months copd * physician diagnosis of copd (including emphysema and/or chronic bronchitis), history of dyspnea and/or intermittent or daily chronic cough with or without sputum production, not attributable to any other known cause * former smoker (≥ 6 months since cessation) with smoking history of ≥ 10 pack years * ≥40 years of age * postbronchodilator fev1/fvc ratio \< 70% * postbronchodilator fev1 ≥ 50% nhanes iii predicted, total lung capacity (tlc) ≥ 80% predicted its, and dlco (unc) ≥ 50% predicted (miller) both * clinical diagnosis of type1 or 2 diabetes mellitus for ≥ 12 months and no change in anti-diabetic regiment for at least 90-days prior to screening * bmi of, \< 39 kg/m2 * urine cotinine level ≤ 100ng/dl * clinical diagnosis of obstructive lung disease * hba1c \> 6.5% ≤ 11.5% exclusion criteria: * history of pulmonary exacerbation within 8 weeks of screening/v1 or between v1 and v2 * use of systemic corticosteroids or antibiotics for respiratory illness within 8 weeks of screening/v1 or between v1 and v2 * increase from baseline in the use of short-acting bronchodilator or short-acting anticholinergic agents, or the combination of the 2, by ≥6 puffs or ≥3 nebulizer treatments per day for ≥ 2 days * treatment with supplemental oxygen therapy, room air oxygen saturation, 94% or history of intubation or icu admission for respiratory illness in the past 5 yrs. * greater than 2 hospitalizations or er or urgent care visits or required \>3 courses of systemic steroid in the past 12 months for respiratory illness * use of symlin® (pramlintide acetate) within the preceding 90 days * two or more severe hypoglycemic episodes within 6 months of screening or episode of severe hypoglycemia between screening and baseline * previous exposure to any inhaled insulin product * currently using an insulin delivery pump * requires significant change (define as initiation of a new medication or change in the dose or frequency of the controller medications) in the asthma or copd therapeutic regimen within 8 weeks of screening/visit 1 (week -4) or between visit 1 and baseline/visit 2 * severe complications of diabetes mellitus, in the opinion of the pi or sub-investigator, including symptomatic autonomic neuropathy; disabling peripheral neuropathy; active proliferative retinopathy; nephropathy with renal failure, renal transplant and/or dialysis; history of foot ulcers; nontraumatic amputations due to gangrene; and/or vascular claudication