Cross-over Study to Evaluate the Effect on Trough Forced Expiratory Volume in One Second (FEV1) After 4 Weeks Treatment With CHF 5188 pMDI qd in Adult Patients With Persistent Asthma

• Status: Completed
• Trial end date: 2010-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Cross-over study to evaluate the effect on trough FEV1 after 4 weeks treatment with CHF5188 pMDI qd in adult patients with persistent asthma

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chiesi Farmaceutici S.p.A.
• Treatments: Budesonide; Fluticasone Propionate, Salmeterol Xinafoate Drug Combination; Fluticasone-Salmeterol Drug Combination

Criteria

Inclusion Criteria:

• Moderate or severe asthma partly controlled with ICS or ICS/LABA

• FEV1 ≥ 60% and ≤ 90% of predicted for the patient normal value

Exclusion Criteria:

• Diagnosis of COPD

• History or current evidence of significant cardiovascular disease

• Uncontrolled concomitant disease