Status:
COMPLETED
A Study Designed to Determine if the Pharmacokinetic Disposition of Inhaled Insulin Exposure is the Same for Asthmatics and Non-asthmatics
Lead Sponsor:
Mannkind Corporation
Conditions:
Asthma
Diabetes Mellitus
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This study will compare the rate and extent of absorption of TI Inhalation Powder in subjects with asthma and subjects with normal lung function. 24 eligible subjects will be enrolled into the treatme...
Detailed Description
Visit 1 screening will determine eligibility and obtain informed consent. At visit 2, 3 and 4 subjects inhale 1 dose of 45U TI Inhalation Powder. At visit 3 subjects inhale 2 puffs (200mcg) Albuterol ...
Eligibility Criteria
Inclusion
- Non smoking male and female subjects = 18 and = 55 years of age with BMI = 34 kg/m2 Fasting blood glucose (FBG) \< 110 mg/dL (6.1 mmol/L). Written informed consent Asthmatic Subjects: Clinical diagnosis of asthma along with defined reversibility from pre- to post-bronchodilator spirometry.
- Pulmonary Function Testing for Asthmatic subjects: FEV1 \> 70% (NHANES III), TLC \>70% (ITS), Dlco \>80% (Miller) Non-asthmatic healthy subjects: FEV1 \> 80% (NHANES III), FEV1/FVC \> LLN (NHANES), TLC \>80% (ITS), Dlco \>80% (Miller), no significant improvement from pre- to post-bronchodilator spirometry.
Exclusion
- Unable and/or unlikely to comprehend how to use the investigational device in this study or to follow study instructions Change in asthma therapeutic regimen from Screening through visit 5 Exacerbation of asthma within 8 weeks prior to Screening History of diabetes mellitus Previous exposure to any inhaled insulin product other than TI inhalation Powder or similar formulation Inability to perform PFT maneuvers meeting recommended American Thoracic Society (ATS) standards of acceptability and repeatability criteria Any clinically important pulmonary disease Major organ system diseases including seizures, heart failure, uncontrolled hypertension, cancer within the past 5 years, aneurysm, 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
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00673621
Start Date
May 1 2008
End Date
December 1 2008
Last Update
June 13 2012
Active Locations (2)
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1
Medicines Evaluation Unit (MEU)
Manchester, England, United Kingdom, M23 9QZ
2
ICON Development Solutions
Manchester, United Kingdom, M15 6SH