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A Study Designed to Determine if the Pharmacokinetic Disposition of Inhaled Insulin Exposure is the Same for Asthmatics and Non-asthmatics
This study has been completed.
First Received: May 5, 2008   Last Updated: October 1, 2009   History of Changes
Sponsor: Mannkind Corporation
Information provided by: Mannkind Corporation
ClinicalTrials.gov Identifier: NCT00673621
  Purpose

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.


Condition Intervention Phase
Asthma
Diabetes Mellitus
Drug: Technosphere Insulin Inhalation Powder
Drug: Salbutamol (Albuterol)
Drug: Methacholine chloride
Phase I

Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Pharmacokinetics Study
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

Resource links provided by NLM:


Further study details as provided by Mannkind Corporation:

Primary Outcome Measures:
  • AUCF 0-360 min of serum insulin [ Time Frame: 0-360 min ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: May 2008
Study Completion Date: December 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental 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%

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00673621

Locations
United Kingdom
ICON Development Solutions
Manchester, United Kingdom, M15 6SH
United Kingdom, England
Medicines Evaluation Unit (MEU)
Manchester, England, United Kingdom, M23 9QZ
Sponsors and Collaborators
Mannkind Corporation
Investigators
Study Chair: Anders H. Boss Mannkind Corporation
  More Information

No publications provided

Responsible Party: MannKind Corporation ( Anders H. Boss. MFPM )
Study ID Numbers: MKC-TI-113
Study First Received: May 5, 2008
Last Updated: October 1, 2009
ClinicalTrials.gov Identifier: NCT00673621     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Mannkind Corporation:
Asthmatics and non-asthmatic male and female subjects

Additional relevant MeSH terms:
Parasympathomimetics
Respiratory System Agents
Neurotransmitter Agents
Cholinergic Agonists
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Bronchial Diseases
Bronchoconstrictor Agents
Albuterol
Physiological Effects of Drugs
Reproductive Control Agents
Cholinergic Agents
Adrenergic Agonists
Insulin
Hypersensitivity
Lung Diseases, Obstructive
Hypoglycemic Agents
Respiratory Tract Diseases
Tocolytic Agents
Therapeutic Uses
Metabolic Diseases
Adrenergic beta-Agonists
Immune System Diseases
Miotics
Diabetes Mellitus
Endocrine System Diseases
Asthma
Anti-Asthmatic Agents
Pharmacologic Actions
Autonomic Agents

ClinicalTrials.gov processed this record on November 27, 2009