MedTrace Logo

Prn Budesonide/Formoterol Versus Regular Budesonide/Formoterol Plus Prn Terbutaline in Mild-Moderate Asthma

NCT00849095 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 860

Last updated 2014-05-30

No results posted yet for this study

Summary

Study No.001 about Budesonide/Formoterol use in ASthMA sponsored by Agenzia Italiana del FArmaco (Italian Drug Agency) (AIFA-ASMA-BF-001) The aim of the study is to verify whether asthma not controlled by low doses inhaled corticosteroids, thus in need for step up therapy, can be equally controlled by guidelines recommended regular bid treatment with long acting beta agonist/inhaled corticosteroid (ICS/LABA) combination or the symptom driven use of an ICS/LABA combination in the absence of maintenance therapy. The study is designed to be able to evaluate the non inferiority of regular placebo plus prn inhaled budesonide/formoterol (experimental treatment) versus regular, twice daily 160/4.5 mcg inhaled budesonide/formoterol combination plus prn inhaled terbutaline (guidelines recommended treatment).

Conditions

Interventions

DRUG

budesonide/formoterol combination (PRN)

budesonide/formoterol combination 160/4.5 mcg 1 inhalation used as needed for a period of 52 weeks

DRUG

budesonide/formoterol combination

budesonide/formoterol 160/4.5 mcg 1 inhalation bid

DRUG

placebo

bid inhaled placebo

DRUG

terbutaline

as needed terbutaline 500 mcg for a period of 52 weeks

Sponsors & Collaborators

  • Università degli Studi di Ferrara

    lead OTHER

Principal Investigators

  • Alberto Papi, MD · Università degli Studi di Ferrara

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2013-04-30
Completion
2013-05-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs
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 NCT00849095 on ClinicalTrials.gov