Inhaled Tacrolimus, Add-on to Inhaled Corticosteroids & Long Acting B2 Agonists in Moderate to Severe Persistent Asthma

Astellas

Status and phase: Completed; Phase 2

Conditions: Bronchial Asthma; Asthma, Bronchial

Treatments: Drug: Tacrolimus

Study type: Interventional

Funder types: Industry

Identifiers

NCT00189722

FG-506-17-05

Details and patient eligibility

About

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

Enrollment: 160 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of asthma
• Patients treated with inhaled corticosteroid and long acting beta 2 agonist
• FEV1(forced expiratory volume in 1 second)>50% to 80%

Exclusion criteria

• Respiratory infection within 2weeks
• Asthma exacerbation within 6 weeks

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind