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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01070524

Enrollment

113

Registered

2010-02-18

Start date

2010-01-31

Completion date

2010-07-31

Last updated

2017-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

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

Interventions

DRUGCHF 5188 pMDI

CHF 5188: fixed combination budesonide/carmoterol

DRUGBudesonide extrafine pMDI

Budesonide extrafine pMDI

DRUGSeretide(r) Evohaler(r)

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

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Trough FEV1 (mean 23h-24h FEV1)	after day 28 dose

Secondary

Measure	Time frame
Trough FEV1 and forced vital capacity (FVC) (mean 23h-24h)	after day 1 dose
Trough FVC (mean 23-24h)	after day 28 dose
Peak FEV1 and FVC	on day 1 and day 28
FEV1 AUC0-24	after day 1 and day 28

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026