NCT01070524

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

A Randomised, Double-blind, Active-controlled, 3 Way Cross-over Study to Evaluate the Effect on Trough FEV1 After 4 Weeks Treatment With CHF 5188 pMDI qd (Fixed Combination Budesonide / Carmoterol) in Adult Patients With Moderate or Severe Persistent Asthma

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 113 (estimated)
• Sponsor: Chiesi Farmaceutici S.p.A. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

A randomised, double-blind, multinational, multicentre, active-controlled, 3-way cross-over study to evaluate the effect on trough FEV1 after 4 weeks treatment with CHF5188 pMDI qd in adult patients with moderate or severe persistent asthma

Conditions

• Asthma

Interventions

Type	Name	Description
DRUG	CHF 5188 pMDI	CHF 5188: fixed combination budesonide/carmoterol
DRUG	Budesonide extrafine pMDI	Budesonide extrafine pMDI
DRUG	Seretide(r) Evohaler(r)	Seretide(r) Evohaler(r): fixed combination fluticasone/salmeterol

Timeline

• Start date: 2010-01-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2010-02-18
• Last updated: 2017-03-30

Locations

1 site across 1 country: United Kingdom