Trial | NCT01070524  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    113
Cross-over study to evaluate the effect on trough FEV1 after 4 weeks treatment with CHF5188 pMDI qd in adult patients with persistent asthma
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
Study Started
Jan 31
2010
Primary Completion
Jul 31
2010
Study Completion
Jul 31
2010
Last Update
Mar 30
2017

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

CHF 5188 pMDI Experimental

Budesonide extrafine pMDI Active Comparator

Seretide(r) Evohaler(r) Active Comparator

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
No Results Posted