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
Phase 2
Completed
- Conditions
- Asthma
- Interventions
- Registration Number
- NCT01070524
- Lead Sponsor
- Chiesi Farmaceutici S.p.A.
- Brief 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 113
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description CHF 5188 pMDI CHF 5188 pMDI - Budesonide extrafine pMDI Budesonide extrafine pMDI - Seretide(r) Evohaler(r) Seretide(r) Evohaler(r) -
- Primary Outcome Measures
Name Time Method Trough FEV1 (mean 23h-24h FEV1) after day 28 dose
- Secondary Outcome Measures
Name Time Method Peak FEV1 and FVC on day 1 and day 28 Trough FEV1 and forced vital capacity (FVC) (mean 23h-24h) after day 1 dose Trough FVC (mean 23-24h) after day 28 dose FEV1 AUC0-24 after day 1 and day 28
Trial Locations
- Locations (1)
The Medicines Evaluation Unit Ltd, The Langley Building, Southmoor Road
🇬🇧Manchester, United Kingdom