NCT00673621

A Study Designed to Determine if the Pharmacokinetic Disposition of Inhaled Insulin Exposure is the Same for Asthmatics and Non-asthmatics

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Mannkind Corporation · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Asthma
• Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	Technosphere Insulin Inhalation Powder	3.0 of human insulin. single dose cartridges filled with 5 or 10 mg of Technosphere Inhalation Powder, containing 15 or 30 u of insulin
DRUG	Salbutamol (Albuterol)	2 puff = 200 mcg total dose
DRUG	Methacholine chloride	5mls of methacholine; diluent sodium chloride 0.9%; formulation methacholine chloride in sodium chloride 0.9%

Timeline

• Start date: 2008-05-01
• Primary completion: 2008-11-01
• Completion: 2008-12-01
• First posted: 2008-05-07
• Last updated: 2012-06-13

Locations

2 sites across 1 country: United Kingdom