A Study Designed to Determine if the Drugs Albuterol (Salbutamol) and Fluticasone Have an Effect on the Pharmacokinetics of the Investigational Product Technosphere® Insulin Inhalation Powder in Healthy Volunteers

Phase 1

Completed

• Conditions: Diabetes Mellitus; Healthy Subjects
• Interventions: Drug: Technosphere Insulin (TI) Inhalation Powder; Drug: Albuterol (Salbutamol); Drug: Fluticasone

• Registration Number: NCT00674050
• Lead Sponsor: Mannkind Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-05-05
• Study First Submitted QC: 2008-05-05
• Study First Posted: 2008-05-07
• Primary Completion: 2008-09
• Study Completion: 2008-10
• Status Verified: 2012-06
• Last Update Submitted: 2012-06-12
• Last Update Posted: 2012-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Technosphere Insulin (TI) Inhalation Powder	-
1	Albuterol (Salbutamol)	-
1	Fluticasone	-

Primary Outcome Measures

Name	Time	Method
PK parameters of serum insulin	0-360 min

Trial Locations

Locations (1)

ICON Development Solutions; 🇬🇧 Manchester, United Kingdom, United Kingdom