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| Sponsor: | Mannkind Corporation |
|---|---|
| Information provided by: | Mannkind Corporation |
| ClinicalTrials.gov Identifier: | NCT00674050 |
Purpose
This study will investigate the effects of inhaled albuterol & fluticasone on one dose of TI Inhalation Powder. A total of 12 eligible subjects will be enrolled.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus Healthy Subjects |
Drug: Technosphere Insulin (TI) Inhalation Powder Drug: Albuterol (Salbutamol) Drug: Fluticasone |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1, Open-Label Study to Investigate the Effect of Albuterol (Salbutamol) and Fluticasone on the Pharmacokinetics of Inhaled Technosphere® Insulin Inhalation Powder in Healthy Subjects |
| Estimated Enrollment: | 12 |
| Study Start Date: | May 2008 |
| Study Completion Date: | October 2008 |
| Primary Completion Date: | September 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: Technosphere Insulin (TI) Inhalation Powder
3.0 U of human insulin. 5 or 10 mg or Technosphere Inhalation Powder, containing 15 0r 30 U of insulin.
Drug: Albuterol (Salbutamol)
2 puff= 200ug total dose
Drug: Fluticasone
2 puffs= 500ug total dose
|
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Subjects must have a fasting blood glucose (BG) level of less than 6.1 mmol/L FEV1/ FVC = LLN TLC = 80% Predicted DLco (unc) = 80% Predicted (Miller) No significant improvement in pre- to post-bronchodilator spirometry (defined as an increase of = 12% and = 200 mL in FEV1 or FVC) at Screening FEV1 = 80% (NHANES III Predicted
Exclusion Criteria:
History of diabetes mellitus Previous exposure to any inhaled insulin product Any known pulmonary disease or inability to perform PFT maneuvers meeting recommended American Thoracic Society (ATS) standards of acceptability and repeatability criteria Respiratory tract infection within 8 weeks prior to Screening/Visit 1 Major organ system diseases including seizures, heart failure, uncontrolled hypertension, aneurysm, cancer within the past 5 years, liver disease, anemia or autoimmune disorder Clinically significant abnormalities on screening laboratory evaluation Female subjects who are pregnant, lactating, or planning to become pregnant during the clinical trial period or not practicing adequate birth control Unable and/or unlikely to comprehend how to use the investigational device in this study or to follow study instructions
Contacts and Locations More Information
| Responsible Party: | Anders H. Boss, MD, MFPM, MannKind Corporation |
| ClinicalTrials.gov Identifier: | NCT00674050 History of Changes |
| Other Study ID Numbers: | MKC-TI-114 |
| Study First Received: | May 5, 2008 |
| Last Updated: | October 14, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
Healthy Males or Females subjects |
|
Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Albuterol Fluticasone Insulin Tocolytic Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists |
Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Hypoglycemic Agents Dermatologic Agents Anti-Allergic Agents Anti-Inflammatory Agents |
