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 Farmaceutici S.p.A.113 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

113

Conditions

Asthma

Interventions

CHF 5188 pMDIDRUG

CHF 5188: fixed combination budesonide/carmoterol

Budesonide extrafine pMDIDRUG

Budesonide extrafine pMDI

Seretide(r) Evohaler(r)DRUG

Seretide(r) Evohaler(r): fixed combination fluticasone/salmeterol

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

The Medicines Evaluation Unit Ltd, The Langley Building, Southmoor Road

Manchester, United Kingdom

Outcomes

Primary Outcomes

Trough FEV1 (mean 23h-24h FEV1)

Time frame: after day 28 dose

Secondary Outcomes

Trough FEV1 and forced vital capacity (FVC) (mean 23h-24h)

Time frame: after day 1 dose

Trough FVC (mean 23-24h)

Time frame: after day 28 dose

Peak FEV1 and FVC

Time frame: on day 1 and day 28

FEV1 AUC0-24

Time frame: after day 1 and day 28

Data from ClinicalTrials.gov

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