A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics With Asthma

Pfizer

Status and phase: Completed; Phase 3

Conditions: Asthma; Diabetes Mellitus

Treatments: Drug: Subcutaneous Insulin; Drug: Inhaled Insulin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00139659

A2171028

Details and patient eligibility

About

A One Year Clinical Trial Assessing the Usefulness and Safety of Inhaled Insulin in Diabetics with Asthma

Enrollment: 288 patients

Sex: All

Ages: 18 to 77 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diabetes Mellitus (Type 1 or Type 2) currently controlled with injected insulin
• Mild intermittent or mild to moderate persistent asthma

Exclusion criteria

• Poorly controlled, unstable or steroid-dependent asthma, insulin pump therapy, smoking

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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288 participants in 2 patient groups

Inhaled Insulin

Experimental group

Treatment:

Drug: Inhaled Insulin

Subcutaneous Insulin

Active Comparator group

Treatment:

Drug: Subcutaneous Insulin