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

Study Identifier:
CCD-0909-PR-0020
ClinicalTrials.gov Identifier:
NCT01070524
EudraCT Identifier:
2009-013759-32
EU CT ID:
N/A
Study Contact Information:
N/A
Study Complete

Study Details

Medical Condition
  • Asthma
Study Drug
  • Drug: CHF 5188 pMDI
  • Drug: Budesonide extrafine pMDI
  • Drug: Seretide(r) Evohaler(r)
Date
Jan 2010 - Jul 2010
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years
Requirements Information
Inclusion and Exclusion 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
Healthy Volunteers
No

Protocol 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

Study Locations

Location
Status
Location
The Medicines Evaluation Unit Ltd, The Langley Building, Southmoor Road
Manchester, United Kingdom, M23 9QZ
Status
N/A