Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-25 @ 12:56 AM
NCT ID:
NCT00757367
Eligibility Criteria:
Inclusion Criteria:
* Nonsmokers for greater than or equal to 12 months
* Normal chest x-ray (CXR) at Screening/Visit 1
* Prebronchodilator FEV1 greater than or equal to 80% Third National Health and Nutrition Examination Survey (NHANES) III Predicted
* Prebronchodilator FEV1/FVC greater than or equal to LLN% NHANES III Predicted
* Prebronchodilator total lung capacity (TLC) greater than or equal to 80% of Predicted Intermountain Thoracic Society (ITS)
* Prebronchodilator Dlco (unc) greater than or equal to 80% Predicted (Miller)
* Written Informed Consent
Exclusion Criteria:
* History of diabetes mellitus
* Previous exposure to TI Inhalation Powder within 3 months of Visit 1, or exposure to any other inhaled insulin product
* Allergy or known hypersensitivity to insulin or to any of the drugs to be used in the trial or a history of hypersensitivity to TI Inhalation Powder or to drugs with a similar chemical structure.
* History of chronic obstructive pulmonary disease (COPD), asthma, and or any other clinically important pulmonary disease (eg, cystic fibrosis, bronchiectasis, and/or sleep apnea) confirmed by PFTs and/or radiologic findings.
* Known allergic or adverse reactions to specified medications
* Seizure disorder, significant cardiovascular dysfunction and/or history within 3 months of Visit 1, uncontrolled hypertension, known history of aortic or cerebral aneurysm, renal dysfunction or disease, serum creatinine \> 2.0 mg/dL in males and \> 1.8 mg/dL in females and/or blood urea nitrogen (BUN) \> 50 mg/dL
* Cancer (other than excised cutaneous basal cell carcinoma) within the past 5 years or any history of lung neoplasms.
* History of active viral and/or cirrhotic hepatic disease and/or abnormal liver enzymes, as evidenced by serum aspartate aminotransferase (AST), and/or alanine aminotransferase (ALT) ? 3x upper limit of normal (ULN).
* Active infection (eg, human immunodeficiency virus (HIV), hepatitis) or history of severe infection within 30 days of Visit 1
* Anemia (hemoglobin value ? 10.5 g/dL for females or ? 11.5 g/dL for males.
* Diagnosis of systemic autoimmune or collagen vascular disease requiring previous or current treatment with systemic corticosteroids, cytotoxic drugs, or penicillamine.
* Current or previous chemotherapy, radiation therapy, or amiodarone use that may result in pulmonary toxicity.
* Clinically significant abnormalities or screening laboratory evaluation (unless approved by the Medical Monitor).
* Female subjects who are pregnant, lactating, or planning to become pregnant during the clinical trial period.
* Female subjects of childbearing potential not practicing adequate birth control.
* Current drug or alcohol abuse or a history of drug or alcohol abuse, that, in the opinion of the PI, would not make the subject a suitable candidate for participation in the clinical trial.
* Exposure to any investigational medications or devices within the previous 30 days prior to trial entry or participation in another clinical trial while participating in the clinical trial.
* Unable and/or unlikely to comprehend and/or follow the trial protocol.
* Unable and/or unlikely to comprehend how to use the MedTone Inhaler Model D or inability to properly use the device.
* A lack of compliance with medication or procedures, that, in the PI's opinion, may affect the clinical trial data or the subject's safety and which precludes the subject from further participation in the clinical trial
* Any other concurrent medical or major psychiatric condition that, in the opinion of the PI, makes the subject unsuitable for the clinical trial, or could limit the validity of the informed consent, and/or impair the subject's ability to participate in the trial.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT00757367
Study Brief:
Protocol Section:
NCT00757367