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Closing Volume Interpretation and Bronchodilators Effect

NCT01437748 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2014-10-29

No results posted yet for this study

Summary

* The gold standard measures to evaluate small airways (SAW) "in vivo" is not well understood
* Two tests are today used to measure SAW but real results concordance is not clear
* These problems have a small evidence
* Data about real effect of bronchodilators on SAW (eg Tiotropium and Indacaterol) has never been studied
* Only an acute bronchodilators effect, after one hour of drugs inhalation, will be evaluated
* The time frame of study evaluations per patient will be of three hours: one hour for basal test; one hour rest after drug administration; one hour for post bronchodilators test
* All enrolled subjects will be outpatients and will be evaluated after 24 hours of inhalatory drugs washout

Conditions

Interventions

DRUG

Indacaterol maleate

Dry powder, 300 mcg, only one inhalation with 24 hours duration

DRUG

Tiotropium bromide

Dry powder, 18 mcg, only one inhalation with 24 hours duration

Sponsors & Collaborators

  • Fondazione Salvatore Maugeri

    collaborator OTHER

  • University of Milan

    lead OTHER

Principal Investigators

  • Pierachille Santus, MD, PhD · Università degli Studi di Milano-Pneumologia Riabilitativa-Fondazione Salvatore Maugeri-MILANO

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2014-09-30
Completion
2014-09-30

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 NCT01437748 on ClinicalTrials.gov