NCT00642616终止3 期
A Phase 3, Open-label, Randomized Clinical Trial to Evaluate the Safety of Technosphere® Insulin Inhalation Powder in Type 1 or Type 2 Diabetic Subjects With Obstructive Pulmonary Disease (Asthma or Chronic Obstructive Pulmonary Disease) Over a 12 Months Treatment Period With a 2 Month Follow-up
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 34
- 主要终点
- Change in Post-bronchodilator FEV1 From Baseline to Week 52
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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)
- •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%
排除标准
- •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
研究组 & 干预措施
Technosphere® Insulin (Asthma)
Experimental
Technosphere® Insulin Inhalation Powder administered prandially in diabetic participants with Asthma
干预措施: Technosphere® Insulin (Drug)
Usual Care (Asthma)
Active Comparator
Usual anti diabetic care in Diabetic participants with Asthma
干预措施: Usual Care (Drug)
Technosphere® Insulin (COPD)
Experimental
Technosphere® Insulin Inhalation Powder administered prandially in diabetic participants with Chronic Obstructive Pulmonary disease (COPD)
干预措施: Technosphere® Insulin (Drug)
Usual Care (COPD)
Active Comparator
Usual anti diabetic care in Diabetic participants with Chronic Obstructive Pulmonary disease (COPD)
干预措施: Usual Care (Drug)
结局指标
主要结局
Change in Post-bronchodilator FEV1 From Baseline to Week 52
时间窗: 52 Weeks
Post-bronchodilator Forced Expiratory Volume in 1 second (FEV1) is measured at the pulmonary function laboratory.
次要结局
- Number of Participants With COPD Exacerbation by Treatment Arm(Baseline to Week 52)
- Number of Participants With Asthma Exacerbation by Treatment Arm(Baseline to Week 52)
- Change in HbA1C From Baseline to Week 52(Baseline, week 52)
研究者
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