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

NCT00673621 | Completed Phase 1

• 1 other identifier: MKC-TI-113
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

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 treatment phase of the trial.

Conditions

Asthma; Diabetes Mellitus

Keywords

Asthmatics and non-asthmatic male and female subjects

Outcome Measures

Primary Outcomes (1)

• AUCF 0-360 min of serum insulin

  0-360 min

Study Arms (1)

1

EXPERIMENTAL

Drug: Technosphere Insulin Inhalation Powder; Drug: Salbutamol (Albuterol); Drug: Methacholine chloride

Interventions

Technosphere Insulin Inhalation Powder DRUG

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

1

Salbutamol (Albuterol) DRUG

2 puff = 200 mcg total dose

1

Methacholine chloride DRUG

5mls of methacholine; diluent sodium chloride 0.9%; formulation methacholine chloride in sodium chloride 0.9%

1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mannkind Corporation: lead

Study Sites (2)

Medicines Evaluation Unit (MEU)

Manchester, England, M23 9QZ, United Kingdom

Location

ICON Development Solutions

Manchester, M15 6SH, United Kingdom

Location

MeSH Terms

Conditions

Asthma; Diabetes Mellitus

Interventions

Albuterol; Methacholine Chloride

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Methacholine Compounds; Trimethyl Ammonium Compounds; Quaternary Ammonium Compounds; Onium Compounds

Study Officials

• Anders H. Boss

  Mannkind Corporation

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2008
• First Posted: May 7, 2008
• Study Start: May 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: December 1, 2008
• Last Updated: June 13, 2012

Record last verified: 2012-06

Locations

GB (2)