| Outcome Measures: |
Primary: Change From Month 3 in Forced Expiratory Volume in 1 Second (FEV1), Change from Month 3: mean of (value of observed FEV1 \[forced expiratory volume in the first second of forced exhalation\] in liters \[L\] at treatment observation minus Month 3 value)., Month 3 through extension Month 60|Change From Baseline in FEV1, Change from baseline: mean of (value of observed FEV1 \[L\] at treatment observation minus baseline value)., Baseline through extension follow up Month 3|Annual Rate of Change in FEV1, Annual rate of change in FEV1 calculated as slope over time \[visit\] for forced expiratory volume in 1 second measured as liters per year (L/yr)., Week -2 through extension follow up Month 3 or end of study|Summary of ≥ 15 % Decliners in FEV1, Number of subjects with a post-baseline FEV1 decrease of ≥ 15 % \[(baseline observed value - visit observed value)/(baseline observed value) \* 100\]; in the absence of an obvious intercurrrent illness, a repeat FEV1 was performed., Month 3 through extension follow up Month 3|Annual Rate of Change in Carbon Monoxide Diffusion Capacity (DLco), Annual rate of change in DLco calculated as slope over time (visit) measured as milliliters per minute per millimeters of mercury per year (ml/min/mmHg/yr)., Week -2 through extension follow up Month 3 or end of study|Change From Baseline in Carbon Monoxide Diffusion Capacity (DLco), Change from baseline: mean of (value of observed DLco \[milliliters per minute per millimeters of mercury (ml/min/mmHg)\] at treatment observation minus baseline value)., Baseline through extension follow up Month 3|Summary of ≥ 20 % Decliners in DLco, Number of subjects with a post-baseline DLco decrease of ≥ 20 % \[(baseline observed value - visit observed value)/(baseline observed value) \* 100\]; in the absence of an obvious intercurrrent illness, a repeat DLco was performed., Month 3 through extension follow up Month 3 | Secondary: Forced Vital Capacity (FVC), Forced Vital Capacity (FVC) measured in liters (L)., Week -3 through extension follow up Month 3 or end of study|Total Lung Capacity (TLC), Total Lung Capacity measured in liters (L)., Baseline through extension follow up Month 3|Change From Baseline in Glycosylated Hemoglobin (HbA1c), Change from baseline: mean of (value of observed HbA1c \[%\] at treatment observation minus baseline value)., Baseline through extension follow up Month 3|Change From Baseline in Fasting Plasma Glucose (FPG), Change from baseline: mean of (value of observed FPG \[milligrams per deciliter (mg/dL)\] at treatment observation minus baseline value)., Baseline through extension follow up Month 3|Change From Baseline in Body Weight, Change from baseline: mean of (value of observed body weight \[kilograms (kg)\] at treatment observation minus baseline value)., Baseline through extension follow up Month 3|Total Daily Long-acting Insulin Dose (Unadjusted for Body Weight), Total daily long-acting insulin dose unadjusted for body weight. Long-acting (units) insulin for inhaled insulin and subcutaneous treatment groups included NPH insulin, Ultralente®, and insulin glargine., Month 3 through extension Month 36|Total Daily Long-acting Insulin (Adjusted for Body Weight), Total daily dose of long-acting insulin adjusted for body weight (units per kilogram \[kg\]). Long-acting (units) insulin for inhaled insulin and subcutaneous treatment groups included NPH insulin, Ultralente®, and insulin glargine., Month 3 through extension Month 36|Total Daily Short-acting Insulin Dose (Unadjusted for Body Weight), Total daily dose of short-acting insulin unadjusted for body weight. Short-acting insulin (milligrams \[mg\]) for the inhaled insulin treatment group was inhaled insulin; short-acting insulin (units) for the subcutaneous insulin treatment group included insulin lispro, insulin aspart, and regular insulin., Month 3 through extension Month 36|Total Daily Short-acting Insulin Dose (Adjusted for Body Weight), Total daily dose of short-acting insulin adjusted for body weight. Short-acting insulin (mg) for the inhaled insulin treatment group was inhaled insulin (mg divided by kg); short-acting insulin (units) for the subcutaneous insulin treatment group included insulin lispro, insulin aspart, and regular insulin (units divided by kg)., Month 3 through extension Month 36|Lipid Panel: Total Cholesterol, High Density Lipoprotein, Low Density Lipoprotein, and Triglycerides, Lipid values for total cholesterol, high density lipoprotein (HDL), low density lipoprotein (LDL), and triglycerides measured as milligrams per deciliter (mg/dL)., Week -4 through Month 24|Hypoglycemic Event Rates, Hypoglycemic event rate; hypoglycemic event identified by characteristic symptoms of hypoglycemia with no blood glucose (BG) check with prompt resolution with food intake, SC glucagon, or intravenous (IV) glucose; characteristic symptoms with BG of 59 mg/dL (3.2 mmol/L) or less with or without symptoms. Crude event rate = total events divided by subject months (elapsed number of months a subject was in the study at each time interval)., Month 1 through extension Month 36|Severe Hypoglycemic Event Rates, Severe hypoglycemic event rate; all 3 criteria were met: subject unable to treat self, exhibited at least 1 neurological symptom (memory loss, confusion, uncontrollable behavior, irrational behavior, unusual difficulty awakening, suspected seizure, loss of consciousness); BG measurement ≤49 mg/dL, or not measured but clinical manifestations reversed by oral carbohydrates, SC glucagon, or IV glucose. Crude event rate: total events divided by subject months multiplied by 100 (\[total events/subject months\]\*100). Subjects months: elapsed number of months subject was in study in each time interval., Month 1 through extension Month 36|Cough Questionnaire, Clinician administered 6 question instrument to measure cough frequency (night, day), severity, timing in relation to short-acting insulin dosing, severity related to insulin dosing (SC or inhaled), and productivity of cough; range 0 (indicates no symptoms) to 4 (indicates severe symptoms). Questionnaire administered at Week 0 then if and only if, cough is identified as an adverse event not explained by a concomitant condition, such as an upper respiratory tract infection., Week 0 and if indicated through extension follow up Month 3|Baseline Dyspnea Index (BDI), Clinician administered instrument to measure the baseline severity of breathlessness (shortness of breath) in symptomatic patients with 3 domains: functional impairment, magnitude of task, and magnitude of effort. BDI score range 0 (very severe impairment) to 4 (no impairment) scaled to a BDI focal score (0-12). Lower score indicates greater impairment., Week -1|Transition Dyspnea Index (TDI), Clinician administered instrument to measure the baseline severity of breathlessness (shortness of breath) in symptomatic patients with 3 domains: functional impairment, magnitude of task, and magnitude of effort. TDI score range -3 (major deterioration) to +3 (major improvement); sum of all domains yields the TDI focal score (-9 to +9); lower score indicates greater deterioration. Compared to previous scoring to determine deterioration or improvement., Week 4 through extension follow up Month 3 or end of study|High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Within Normal Limits, Number of subjects with Yes or No responses (within normal limits at specified time points = Yes or not within normal limits at specified time points = No) at observation when HRCT of thorax was within normal limits at baseline., Baseline, M12, M24, Ext M6, Ext M18, Ext M36|High Resolution Computerized Tomography (HRCT) Scan: Within Normal Limits (Yes or No) at Observation When Baseline HRCT Was Not Within Normal Limits, Number of subjects with Yes or No responses (within normal limits at specified time points = Yes or not within normal limits at specified time points = No) at observation when HRCT of thorax was not within normal limits at baseline. "No" response at observation further categorized as no significant change (NSC), more abnormal (\> Abn), or less abnormal (\< Abn)., Baseline, M12, M24, Ext M6, Ext M18, Ext M36|Insulin Antibodies, Observed values for insulin antibodies measured as micro units per milliliter (microU/mL)., Baseline through extension Month 36
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| Locations: |
Pfizer Investigational Site, Phoenix, Arizona, 85016, United States|Pfizer Investigational Site, Tucson, Arizona, 85715, United States|Pfizer Investigational Site, Fresno, California, 93720, United States|Pfizer Investigational Site, Greenbrae, California, 94904, United States|Pfizer Investigational Site, Los Angeles, California, 90073, United States|Pfizer Investigational Site, Sacramento, California, 95816, United States|Pfizer Investigational Site, San Diego, California, 92103, United States|Pfizer Investigational Site, San Diego, California, 92108, United States|Pfizer Investigational Site, San Luis Obispo, California, 93401, United States|Pfizer Investigational Site, Tustin, California, 92780, United States|Pfizer Investigational Site, Walnut Creek, California, 94598, United States|Pfizer Investigational Site, Denver, Colorado, 80209, United States|Pfizer Investigational Site, Hamden, Connecticut, 06518, United States|Pfizer Investigational Site, Madison, Connecticut, 06443, United States|Pfizer Investigational Site, New Britain, Connecticut, 06050, United States|Pfizer Investigational Site, Waterbury, Connecticut, 06708, United States|Pfizer Investigational Site, Chiefland, Florida, 32626, United States|Pfizer Investigational Site, Clearwater, Florida, 33761, United States|Pfizer Investigational Site, Fort Myers, Florida, 33901, United States|Pfizer Investigational Site, Hollywood, Florida, 33021, United States|Pfizer Investigational Site, Miami, Florida, 33156, United States|Pfizer Investigational Site, Ocala, Florida, 34471, United States|Pfizer Investigational Site, Palm Harbor, Florida, 34684, United States|Pfizer Investigational Site, Tallahassee, Florida, 32308, United States|Pfizer Investigational Site, West Palm Beach, Florida, 33401, United States|Pfizer Investigational Site, Honolulu, Hawaii, 96813, United States|Pfizer Investigational Site, Honolulu, Hawaii, 96814, United States|Pfizer Investigational Site, Chicago, Illinois, 60602, United States|Pfizer Investigational Site, Chicago, Illinois, 60607, United States|Pfizer Investigational Site, Chicago, Illinois, 60610, United States|Pfizer Investigational Site, Springfield, Illinois, 62704, United States|Pfizer Investigational Site, Wilmette, Illinois, 60091, United States|Pfizer Investigational Site, New Orleans, Louisiana, 70112, United States|Pfizer Investigational Site, Bethesda, Maryland, 20817, United States|Pfizer Investigational Site, Boston, Massachusetts, 02215, United States|Pfizer Investigational Site, Ann Arbor, Michigan, 48106, United States|Pfizer Investigational Site, Bloomfield Hills, Michigan, 48302, United States|Pfizer Investigational Site, Plymouth, Michigan, 48170, United States|Pfizer Investigational Site, Royal Oak, Michigan, 48073, United States|Pfizer Investigational Site, Southfield, Michigan, 48034, United States|Pfizer Investigational Site, Chesterfield, Missouri, 63017, United States|Pfizer Investigational Site, St. Louis, Missouri, 63141, United States|Pfizer Investigational Site, Butte, Montana, 59701, United States|Pfizer Investigational Site, Lincoln, Nebraska, 68521, United States|Pfizer Investigational Site, Henderson, Nevada, 89014, United States|Pfizer Investigational Site, Albuquerque, New Mexico, 87108, United States|Pfizer Investigational Site, Albuquerque, New Mexico, 87109, United States|Pfizer Investigational Site, Mineola, New York, 11501, United States|Pfizer Investigational Site, New Hyde Park, New York, 11042, United States|Pfizer Investigational Site, Rochester, New York, 14609, United States|Pfizer Investigational Site, Durham, North Carolina, 27713, United States|Pfizer Investigational Site, Winston-Salem, North Carolina, 27103, United States|Pfizer Investigational Site, Mansfield, Ohio, 44903, United States|Pfizer Investigational Site, Tulsa, Oklahoma, 74104, United States|Pfizer Investigational Site, Warwick, Rhode Island, 02886, United States|Pfizer Investigational Site, Beaumont, Texas, 77701, United States|Pfizer Investigational Site, Beaumont, Texas, 77706, United States|Pfizer Investigational Site, Corpus Christi, Texas, 78411, United States|Pfizer Investigational Site, Corpus Christi, Texas, 78412, United States|Pfizer Investigational Site, Dallas, Texas, 75230, United States|Pfizer Investigational Site, Dallas, Texas, 75231, United States|Pfizer Investigational Site, Dallas, Texas, 75246, United States|Pfizer Investigational Site, Houston, Texas, 77079, United States|Pfizer Investigational Site, Irving, Texas, 75061, United States|Pfizer Investigational Site, San Antonio, Texas, 78229, United States|Pfizer Investigational Site, Burlington, Vermont, 05401, United States|Pfizer Investigational Site, Richmond, Virginia, 23225, United States|Pfizer Investigational Site, Renton, Washington, 98055, United States|Pfizer Investigational Site, Milwaukee, Wisconsin, 53209, United States|Pfizer Investigational Site, Porto Alegre, RS, 90035-170, Brazil|Pfizer Investigational Site, Sao Paulo, SP, 01244-030, Brazil|Pfizer Investigational Site, Calgary, Alberta, T2T 5C7, Canada|Pfizer Investigational Site, Calgary, Alberta, T3B 0M3, Canada|Pfizer Investigational Site, Red Deer, Alberta, T4N 6V7, Canada|Pfizer Investigational Site, Victoria, British Columbia, V8R 1J8, Canada|Pfizer Investigational Site, Winnepeg, Manitoba, R3A 1R9, Canada|Pfizer Investigational Site, Winnipeg, Manitoba, R3E 3P4, Canada|Pfizer Investigational Site, Halifax, Nova Scotia, B3H 1V7, Canada|Pfizer Investigational Site, Halifax, Nova Scotia, B3H 2Y9, Canada|Pfizer Investigational Site, London, Ontario, N6A 4V2, Canada|Pfizer Investigational Site, Ottawa, Ontario, K1H 1A2, Canada|Pfizer Investigational Site, Toronto, Ontario, M4N-3M5, Canada|Pfizer Investigational Site, Toronto, Ontario, M5G 1X5, Canada|Pfizer Investigational Site, Laval, Quebec, H7T 2P5, Canada|Pfizer Investigational Site, Montreal, Quebec, H1T 2M4, Canada|Pfizer Investigational Site, Montreal, Quebec, H3A 1A1, Canada|Pfizer Investigational Site, Saskatoon, Saskatchewan, S7N 0W8, Canada|Pfizer Investigational Site, Aguas Buenas, 00703, Puerto Rico|Pfizer Investigational Site, Anasco, 00610, Puerto Rico|Pfizer Investigational Site, Cabo Rojo, 00623, Puerto Rico|Pfizer Investigational Site, San Juan, 00909, Puerto Rico|Pfizer Investigational Site, San Juan, 00921, Puerto Rico
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