Dose Response of Inhaled Tacrolimus in Patients With Moderate Persistent Asthma

Astellas

Status and phase: Completed; Phase 2

Conditions: Bronchial Asthma; Asthma, Bronchial

Treatments: Drug: tacrolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT00189787

FG-506-17-07

Details and patient eligibility

About

This study will evaluate the efficacy and safety of tacrolimus in patients with asthma.

Enrollment: 370 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of asthma
• Patients treated with inhaled corticosteroid
• FEV1 (forced expiratory volume in 1 second)>60% to 80%

Exclusion criteria

• Respiratory infection within 2 weeks
• Asthma exacerbation within 90 days

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind