Efficacy and Safety of Inhaled Human Insulin (Exubera) Compared With Subcutaneous Human Insulin in the Therapy of Adult Subjects With Type 1 or Type 2 Diabetes Mellitus and Chronic Asthma: A One-Year, Multicenter, Randomized, Outpatient, Open-Label, Parallel-Group Comparative Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 288
- 试验地点
- 1
- 主要终点
- Annualized Rate of Change for Forced Expiratory Volume in 1 Second (FEV1)
研究概览
简要总结
A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics with Asthma
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 77 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diabetes Mellitus (Type 1 or Type 2) currently controlled with injected insulin
- •Mild intermittent or mild to moderate persistent asthma
排除标准
- •Poorly controlled, unstable or steroid-dependent asthma, insulin pump therapy, smoking
研究组 & 干预措施
Inhaled Insulin
干预措施: Inhaled Insulin (Drug)
Subcutaneous Insulin
干预措施: Subcutaneous Insulin (Drug)
结局指标
主要结局
Annualized Rate of Change for Forced Expiratory Volume in 1 Second (FEV1)
时间窗: Weeks -3, -2, -1, 1, 2, 3, 4, 6, 12, 18, 26, 39, and 52
Annualized rates of change (slope throughout time from baseline to end of study\[visit\]) for forced expiratory volume in 1 second (FEV1) (liters per year \[L/yr\]) measured 30 minutes following the administration of albuterol.
Annualized Rate of Change for Hemoglobin-adjusted Carbon Monoxide Diffusion Capacity (DLco)
时间窗: Weeks -3, -2, -1, 1, 2, 3, 4, 6, 12, 18, 26, 39, and 52
Annualized rates of change (slope throughout time from baseline to end of study\[visit\]) for hemoglobin-adjusted carbon monoxide diffusion capacity (DLco)in milliliters per minute/millimeters of mercury/year (ml/min/mmHg/yr) measured 30 minutes following the administration of albuterol.
Change From Baseline in Post-Bronchodilator Forced Expiratory Volume in One Second (FEV1)
时间窗: Baseline through Week 52 Last Observation Carried Forward (LOCF)
Change from Baseline at each visit in post-bronchodilator forced expiratory volume in one second (FEV1). FEV1 was measured in liters (L) 30 minutes following the administration of albuterol. Change from baseline: mean FEV1 (L) at observation minus baseline value.
Change From Baseline in Post-Bronchodilator Carbon Monoxide Diffusing Capacity (DLco)
时间窗: Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF)
Carbon Monoxide Diffusing Capacity (DLco) measured in milliters/minutes/millimeters of mercury (mL/min/mmHg) 30 minutes following the administration of albuterol. Change from Baseline: mean DLco (mL/min/mmHg) at observation minus baseline value.
次要结局
- Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in One Second (FEV1)(Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF))
- Change From Baseline in Pre-Bronchodilator Carbon Monoxide Diffusing Capacity (DLco)(Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation carried Forward (LOCF))
- Change From Baseline in Pre-Insulin Forced Expiratory Volume in One Second (FEV1)(Baseline, Week 9, Week 51, Week 51 Last Observation Carried Forward)
- Change From Baseline in Pre-Insulin Carbon Monoxide Diffusing Capacity (DLco)(Baseline, Week 9, Week 51, Week 51 Last Observation Carried Forward (LOCF))
- Change From Baseline in Post-bronchodilator Forced Vital Capacity (FVC)(Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF))
- Bronchodilator Responsiveness as Determined by the Change in Forced Expiratory Volume in 1 Second (FEV1) Pre-albuterol and 30 Minutes Post-albuterol(Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52)
- Percent Predicted and Percent Change From Baseline in Post-Bronchdilator Forced Expiratory Volume in One Second (FEV1)(Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 12, Week 18, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF))
- Change From Baseline in Insulin Dose Responsiveness for Forced Expiratory Volume in One Second (FEV1) Measured 10 and 60 Minutes After the First Daily Dose of Insulin(Baseline, Week 9, Week 51)
- Percent Predicted and Percent Change From Baseline in 10 Minute and 60 Minute Post-Insulin Forced Expiratory Volume in One Second (FEV1)(Baseline, Week 9, Week 51, Week 51 Last Observation Carried Forward (LOCF))
- Change From Baseline in Insulin Dose Responsiveness for Carbon Monoxide Diffusing Capacity (DLco) Measured 10 and 60 Minutes After the First Daily Dose of Insulin(Baseline, Week 9, Week 51)
- Methacholine Challenge(1 to 2 days following Weeks -3 and -1 visits, and at Week 11, Week 50, and Week 52 (+5))
- Mean Weekly Morning and Evening Peak Expiratory Flow Rate (PEFR) and Forced Expiratory Volume in 1 Second (FEV1)(Week -3 through Week 52)
- Mean Weekly Number of Puffs of Albuterol Used (Rescue Medication)(Daily: Baseline to end of study)
- Number of Subjects With Step-up and Step-down Changes in Classification of Asthma Severity by Medication Usage(Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52, Week 54, Week 58)
- Step Classification of Asthma Severity by Medication Usage(Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52, Week 54, Week 58)
- Mean Weekly Asthma Symptom Scores(Baseline through end of study)
- Incidence of Non-severe Asthma Exacerbations(0 to 1 week to > 12 months)
- Incidence of Severe Asthma Exacerbations(0 to 1 Week to > 12 Months)
- Number of Systemic Corticosteroid Rescues(Baseline through Week 52)
- Asthma Control as Measured by the Asthma Control Questionnaire©(Baseline, Weeks 4, 12, 26, 39, 52)
- Baseline Dyspnea Index (BDI)(run-in period)
- Transition Dyspnea Index (TDI): Change in Total Score(Week 4, Week 12, Week 26, Week 39, Week 52)
- Glycosylated Hemoglobin (HbA1c)(Baseline, Week 6, Week 12, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF))
- Fasting Plasma Glucose(Baseline, Week 6, Week 12, Week 26, Week 39, Week 52, Week 52 Last Observation Carried Forward (LOCF))
- Body Weight: Mean Baseline and Change From Baseline(Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 11, Week 12, Week 18, Wek 26, Week 39, Week 50, Week 51, Week 52, Week 52 Last Observation Carried Forward (LOCF))
- Total Daily Long-Acting Insulin Dose (Unadjusted for Body Weight)(Baseline, Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52)
- Total Daily Long-Acting Insulin Dose Adjusted for Body Weight(Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52)
- Total Daily Short-Acting Insulin Dose (Unadjusted for Body Weight)(Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52)
- Total Daily Short-Acting Insulin Dose Adjusted for Body Weight(Week 1, Week 2, Week 3, Week 4, Week 6, Week 9, Week 12, Week 18, Week 26, Week 39, Week 52)
- Lipids: Median Change From Baseline to Last Observation(Baseline to Last Observation)
- Hypoglycemic Event Rates(0 to 1 month to 11 to 12 months, and Overall)
- Severe Hypoglycemic Event Rates(0 to 1 month to 11 to 12 months, and Overall)