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Clinical Trials/NCT01070524
NCT01070524CompletedPhase 2

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

Chiesi Farmaceutici S.p.A.1 site in 1 country113 target enrollmentStarted: January 2010Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
113
Locations
1
Primary Endpoint
Trough FEV1 (mean 23h-24h FEV1)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

CHF 5188 pMDI

Experimental

Intervention: CHF 5188 pMDI (Drug)

Budesonide extrafine pMDI

Active Comparator

Intervention: Budesonide extrafine pMDI (Drug)

Seretide(r) Evohaler(r)

Active Comparator

Intervention: Seretide(r) Evohaler(r) (Drug)

Outcomes

Primary Outcomes

Trough FEV1 (mean 23h-24h FEV1)

Time Frame: after day 28 dose

Secondary Outcomes

  • 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)

Investigators

Sponsor Class
Industry

Study Sites (1)

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