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

Chiesi

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: Budesonide extrafine pMDI; Drug: Seretide(r) Evohaler(r); Drug: CHF 5188 pMDI

Study type: Interventional

Funder types: Industry

Identifiers

NCT01070524

CCD-0909-PR-0020

2009-013759-32 (EudraCT Number)

Details and patient eligibility

About

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

Full 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

Enrollment: 113 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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113 participants in 3 patient groups

CHF 5188 pMDI

Experimental group

Treatment:

Drug: CHF 5188 pMDI

Budesonide extrafine pMDI

Active Comparator group

Treatment:

Drug: Budesonide extrafine pMDI

Seretide(r) Evohaler(r)

Active Comparator group

Treatment:

Drug: Seretide(r) Evohaler(r)