EUCTR2008-000564-16-SKActive, not recruitingNot Applicable
A Phase 3, Multicenter, 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-month Treatment Period with a 2-month Follow-up
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- MannKind Corporation
- Enrollment
- 510
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Key inclusion criteria include:
- •Male and female subjects with clinical diagnoses of type 1 or 2 diabetes mellitus for = 12 months and no change in their antidiabetic regimen for at least 90 days prior to screening
- •Body mass index (BMI) of < 39 kg/m2
- •HbA1c > 6.5% and = 11.5%
- •Urine cotinine level = 100 ng/dL
- •For subjects diagnosed with 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 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 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 (This test must be performed only after a short-acting bronchodilator medication(s) is withheld for 6 hours and a long-acting bronchodilator medication(s) is withheld for 24 hours) or a documented positive methacholine challenge test within the past 12 months
- •For subjects diagnosed with 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)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 459
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 51
Exclusion Criteria
- •History of a pulmonary exacerbation within 8 weeks of Screening/Visit 1 (Week -4)
- •Use of systemic corticosteroids or antibiotics for a respiratory illness within 8 weeks of Screening/Visit 1 (Week -4)
- •Treatment with supplemental oxygen therapy for a respiratory illness for ? 2 days within the 12 months prior to Screening/Visit 1 (Week -4)
- •History of intubation or intensive care unit admission for a respiratory illness within the past 5 years
- •Greater than 2 hospitalizations or emergency room (ER) or urgent care visits requiring systemic corticosteroid treatment, or required = 3 courses of systemic corticosteroids in the past 12 months for a respiratory illness
- •Clinically significant abnormal chest x-ray (in the opinion of PI or the sub-investigator) at Screening/Visit 1 (Week 4)
- •Any other clinically important pulmonary disease (eg, interstitial lung disease, cystic fibrosis, bronchiectasis, etc) confirmed by pulmonary function tests (PFTs) and/or radiological findings
- •Inability to perform pulmonary function testing that meets American Thoracic Society/European Respiratory Society (ATS/ERS) quality recommendations for acceptability or repeatability
- •Respiratory tract infection within 30 days prior to screening (subject may return 30 days after resolution of the infection for re-screening). If a subject has symptoms of a respiratory tract infection upon arrival at the clinical site for Baseline/Visit 2, the subject should be rescheduled for Visit 2, 30 days after the resolution of respiratory tract infection symptoms
- •Requires significant change (defined as initiation of a new medication or change in the dose or frequency of the controller medication) in the asthma or COPD therapeutic regimen within 8 weeks of Screening/Visit 1 or between Visit 1 and Baseline/Visit 2
- •Known allergy to insulin or any of the drugs to be used in the clinical trial
- •Serum creatinine > 2.0 mg/dL (176.80 mmol/L) in males and > 1.8 mg/dL (159.12 mmol/L) in females. In subjects taking metformin, serum creatinine > 1.5 mg/dL (132.60 mmol/L) in males and > 1.4 mg/dL (123.8 mmol/L) in females
- •Evidence of serious complications of diabetes mellitus (eg, symptomatic autonomic neuropathy, advanced nephropathy, active proliferative retinopathy, severe peripheral vasculopathy)
- •Females who are pregnant or lactating or who plan to become pregnant during the clinical trial period
- •Exposure to any investigational product(s) in the past 3 months
Investigators
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