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A Study in Patients With Asthma

NCT01570478 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2017-03-29

No results posted yet for this study

Summary

The purpose of the present study is to demonstrate the higher efficacy of Foster® NEXThaler® 100/6 extra fine (two inhalations b.i.d.) versus Seretide® Accuhaler® 250/50 (one inhalation b.i.d.), in terms of pulmonary function (change from baseline to the end of treatment in post-dose peripheral airway resistance) in patients with asthma.

Conditions

Interventions

DRUG

Foster® NEXThaler® 100/6 µg/unit dose

Foster® NEXThaler® (beclomethasone dipropionate 100 µg plus formoterol 6 µg per actuation), 2 inhalations b.i.d. (daily dose of BDP 400 µg plus FF 24 µg)

DRUG

Seretide® Accuhaler® 250/50 µg/actuation

Seretide® Accuhaler® (fluticasone propionate 250 μg plus salmeterol xinafoate 50 μg per actuation), 1 inhalation b.i.d. (daily dose of fluticasone 500 μg plus salmeterol 100 μg)

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Alfredo Chetta, MD · Dept. of Cardiology and Pulmonary Medicine - Pama, Italy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • Italy

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 NCT01570478 on ClinicalTrials.gov