Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
Official title:
A Phase 1b, Single-Dose, Open-Label, Parallel, Controlled Pharmacology Trial of Inhaled Technosphere®/Insulin in Non-Diabetic Subjects With COPD Versus Matched Non-Diabetic Subjects Without COPD.
Verified date | December 2013 |
Source | Mannkind Corporation |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
Trial will include 40 subjects and consists of 3 visits: Screening, Treatment and Follow up. A euglycemic clamp procedure and Technosphere®/Insulin (T/I) administration will occur at Visit 2 for both COPD and non COPD subjects.
Status | Completed |
Enrollment | 39 |
Est. completion date | November 2008 |
Est. primary completion date | August 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Male and female subjects minimum 18 and maximum 70 years of age - Body Mass Index (BMI) = 36 kg/m2 - Subjects with COPD: Diagnosis of COPD (emphysema and/or chronic bronchitis), - smoking history =10 years, chronic cough present intermittently or daily with or without sputum and/or dyspnea upon exertion. - Subjects with COPD: Pulmonary Function Tests - FEV1 =50% (NHANES) III - Predicted; FEV1/FVC < 70 % (NHANES) III; TLC =80% of Predicted (ITS) and DLco(unc) =50% of Predicted (Miller) - Subjects without COPD: PFTs: FEV1 = 70% NHANES III Predicted; TLC =80% of - Predicted (ITS) and DLco(unc) =80% of Predicted (Miller) Exclusion Criteria: - History of pre-diabetes or diabetes - Previous or current treatment with any anti-diabetic drugs - Serum creatinine > 2.0 mg/dL in males and > 1.8 mg/dL in females - Active smokers defined as having smoked their last cigarette, pipe, and/or cigar without the previous 6 months - Previous exposure to any inhaled insulin product or investigational medicines/devices within the previous 30 days prior to entry or participation - Clinically significant major organ disease - Female subjects of childbearing potential not practicing adequate birth control - Subjects with COPD: Significant improvement in pre-to post-bronchodilator spirometry (defined as an increase of 12% AND 200 mL in either FVC or FEV1); - Any clinically important pulmonary disease except mild or moderate COPD - Subjects without COPD: Any important pulmonary disease confirmed by pulmonary function testing and/or radiologic findings |
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Austria | Medical University Graz | Graz | |
Netherlands | University Medical Centre Groningen | Zuidlaren | |
United Kingdom | ICON Development Solutions | Manchester | |
United Kingdom | Medicines Evaluation Unit (MEU) | Manchester | England |
United States | Diabetes & Glandular Disease Research Assoc PA | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
Mannkind Corporation |
United States, Austria, Netherlands, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate the pharmacokinetic disposition of serum insulin and serum fumaryl diketopiperazine following dosing with 30 U T/I, as measured via Area Under the Curve serum insulin and AUC 0-480 min serum FDKP | 30 days | No | |
Secondary | Efficacy endpoints include: additional PK parameters of serum insulin and serum FDKP, Pharmacodynamic parameters of sersum insulin, safety of T/I | 30 days | No |
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