A Study Designed to Determine if the Pharmacokinetic Disposition of Inhaled Insulin Exposure is the Same for Asthmatics and Non-Asthmatics
Information source: Mannkind Corporation
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma; Diabetes Mellitus
Intervention: Technosphere Insulin Inhalation Powder (Drug); Salbutamol (Albuterol) (Drug); Methacholine chloride (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Mannkind Corporation Official(s) and/or principal investigator(s):
Anders H. Boss, Study Chair, Affiliation: Mannkind Corporation
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 treatment phase of the trial.
Clinical Details
Official title: A Phase 1, Open-Label, Controlled Clinical Trial to Evaluate Pharmacokinetics After Administration of Technosphere® Insulin Inhalation Powder Alone and With Salbutamol (Albuterol) and/or After Methacholine Challenge Testing in Subjects With Asthma Versus Matched Healthy Subjects Without Asthma
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacokinetics Study
Primary outcome: AUCF 0-360 min of serum insulin
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 prior to dosing. Only asthmatic subjects undergo visit 4 where a
methacholine challenge test (MCT) is performed followed by inhalation of Albuterol then
administration of TI Inhalation Powder. Each visit's dosing will occur during a
hyperinsulinemic euglycemic clamp. Visit 5 is the follow up visit.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
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 Criteria:
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
Locations and Contacts
ICON Development Solutions, Manchester M15 6SH, United Kingdom; Recruiting
Cyril Clarke, Dr, Phone: 011441612322723
Medicines Evaluation Unit (MEU), Manchester, England M23 9QZ, United Kingdom; Recruiting
Dave Singh, Dr, Phone: +44 (0)161 946 4050
Additional Information
Starting date: May 2008
Ending date: November 2008
Last updated: September 22, 2008
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