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A Study Comparing the Efficacy and Safety of CHF 1535 (BDP +FF) Inhalation Powder, Administered Via the NEXT Inhaler, Versus CHF 1535 (BDP +FF), Administered Via a pMDI, in Moderate to Severe Asthma

NCT00862394 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 783

Last updated 2018-04-13

No results posted yet for this study

Summary

To demonstrate that CHF 1535 via NEXT DPI (beclomethasone dipropionate + formoterol fumarate 100 + 6 μg), 1 inhalation or 2 inhalations twice daily, for 12 weeks is non-inferior to the corresponding dose of CHF 1535 via HFA-134a "extrafine" pMDI in terms of pulmonary function in moderate to severe symptomatic asthmatic patients aged ≥ 12 years under treatment with inhaled corticosteroids

Conditions

Interventions

DRUG

BDP/Formoterol Next DPI

BDP/Formoterol Next DPI 100/6 µg (daily dose : 200/12 µg)

DRUG

Foster

BDP/Formoterol HFA pMDI 100/6 µg (daily dose : 200/12 µg)

DRUG

BDP/Formoterol Next DPI

BDP/Formoterol 100/6 µg (daily dose : 400/24 µg)

DRUG

Foster

BDP/Formoterol HFA pMDI 100/6 µg (daily dose : 400/24 µg)

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2009-10-31
Completion
2010-01-31

Countries

  • Germany

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 NCT00862394 on ClinicalTrials.gov