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Efficacy of CHF1535 Via NEXT DPI Versus pMDI and BDP DPI100µg on PeakExpiratoryFlow in Asthmatic Patients

NCT01345916 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 932

Last updated 2017-03-30

No results posted yet for this study

Summary

The purpose of this study is to demonstrate that CHF 1535 NEXT DPI® is non-inferior to the corresponding dose of CHF 1535 pMDI and superior to marketed beclomethasone DPI 100 µg in terms of average pre-dose morning Peak Expiratory Flow (PEF) in asthmatic adult patients.

Conditions

Interventions

DRUG

CHF 1535 100/6 NEXT DPI® 2 months

CHF 1535 100/6 NEXT DPI® 2 months

DRUG

CHF 1535 100/6 pMDI 2 months

CHF 1535 100/6 pMDI 2 months

DRUG

BDP DPI 2 months

BDP DPI 2 months

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Frank KANNIESS, Dr · Gemeinschaftspraxis Reinfeld - Raiffeisenpassage 15 - D-23858 Reinfeld - Germany

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-03-31
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • Poland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01345916 on ClinicalTrials.gov