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Effects on Small Airways of Two Long-term Extrafine Treatments in Asthma

NCT01255579 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2010-12-07

No results posted yet for this study

Summary

New formulations of extrafine particles of long acting beta-2 agonists+inhaled corticosteroids (LABA+ICS) are able to reach more peripheral regions of the lung.

Objectives.The aim of this study was to assess the effect on small airways obstruction of long-term treatments with two different LABA+ICS combinations in asthma.

Patients and methods.Ten subjects with moderate persistent asthma were enrolled. After a 4-week washout they were treated in a randomized cross-over design for 24 weeks with formoterol 12 mcg and beclometasone 200 mcg HFA (by MDI) b.i.d. (FB) or salmeterol 50 mcg and fluticasone 250 mcg (diskus) b.i.d. (SF). At baseline and at the end of each period subjects underwent Asthma Control Test (ACT) and Pulmonary Function Testing. The N2 phase III slope and closing volume (CV) during single breath washout test, and DElta(Heliox-air)MEF50% were measured to assess changes on peripheral airways function.

Conditions

  • Bronchial Asthma

Interventions

DRUG

Salmeterol Fluticasone

salmeterol 50 mcg and fluticasone 250 mcg (diskus) b.i.d.

DRUG

formoterol - beclometasone

formoterol 12 mcg and beclometasone 200 mcg HFA (by MDI) b.i.d.

Sponsors & Collaborators

  • Università degli Studi di Brescia

    lead OTHER

Principal Investigators

  • Claudio Tantucci, MD · Università degli Studi di Brescia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2008-12-31

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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 NCT01255579 on ClinicalTrials.gov