Patient Transitioning From Exubera® Inhalation Powder to Technosphere® Insulin Inhalation Powder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NO_LONGER_AVAILABLE

Study Classification

EXPANDED_ACCESS

Study Start Date

2008-10-31

Study Completion Date

2015-05-31

Brief Summary

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The purpose of this study is to allow patients with specific needs for inhaled insulin to continue with inhaled insulin therapy using Technosphere Insulin after Exubera was withdrawn from the market.

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Detailed Description

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A Phase 3, open label, multicenter, safety follow up trial to convert the treatment of subjects currently using Exubera to treatment with TI Inhalation Powder

Conditions

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Type 1 Diabetes Type 2 Diabetes

Interventions

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Technosphere Insulin Inhalation Powder

Patient Transitioning From Exubera® Inhalation Powder to Technosphere® Insulin Inhalation Powder

Intervention Type DRUG

Other Intervention Names

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Afrezza Inhalation Powder

Eligibility Criteria

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Inclusion Criteria

* Subject has type 1 or type 2 diabetes mellitus and is currently being treated with or has been treated with Exubera.
* Subject has a severe phobia to sc injections of insulin (needle phobia) preventing conventional treatment OR has impaired sc insulin absorption

Exclusion Criteria

* Smoking in the previous 6 months
* History of asthma or chronic obstructive pulmonary disease (COPD) or any other significant pulmonary disease, or exposure to pulmonary toxins.
* Clinically significant pulmonary abnormalities on chest high-resolution computed tomography (HRCT).
* PFT results prior to transferring to TI Inhalation Powder showing any of the following: FEV1 \< 70% of predicted, FVC \< 70% of predicted, DLCO \< 70% of predicted, TLC \< 80% of predicted.
* Allergy to insulin

Eligible Sex

ALL

Accepts Healthy Volunteers

No