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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.
Sponsor:
Information provided by (Responsible Party):
Mannkind Corporation
ClinicalTrials.gov Identifier:
NCT00673621
First received: May 5, 2008
Last updated: June 12, 2012
Last verified: June 2012
  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 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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 ]

Enrollment: 30
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
Experimental: 1 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

Responsible Party: Mannkind Corporation
ClinicalTrials.gov Identifier: NCT00673621     History of Changes
Other Study ID Numbers: MKC-TI-113
Study First Received: May 5, 2008
Last Updated: June 12, 2012
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:
Asthma
Diabetes Mellitus
Bronchial Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Metabolic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Albuterol
Insulin
Insulin, Globin Zinc
Methacholine Chloride
Adrenergic Agents
Adrenergic Agonists
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Anti-Asthmatic Agents
Autonomic Agents
Bronchoconstrictor Agents
Bronchodilator Agents
Cholinergic Agents
Cholinergic Agonists
Hypoglycemic Agents
Miotics
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on November 25, 2014