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

Sponsor
Università degli Studi di Ferrara (Other)
Overall Status
Completed
CT.gov ID
NCT00849095
Collaborator
(none)
860
Enrollment
31
Locations
2
Arms
49
Duration (Months)
27.7
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Drug: budesonide/formoterol combination (PRN)
  • Drug: budesonide/formoterol combination
  • Drug: placebo
  • Drug: terbutaline
 Phase 3

Detailed Description

Asthma is a problem worldwide, with an estimated 300 million affected individuals.There is evidence that asthma prevalence has been increasing in the last decades in some countries, including Italy. Analyses of the cost of asthma lead to conclude that the burden of the disease depend on the extent to which exacerbations are avoided since emergency treatment is more expensive than regular treatment.

Based on solid evidence, international guidelines recommend regular treatment with low dose ICS for mild persistent asthma and treatment with combination therapy [low dose ICS plus long-acting beta2-agonists (LABA)] for patients with asthma not controlled by low doses ICS alone. Recent studies have undermined the axiom that treatment with ICS must be regular to achieve and maintain asthma control, as equivalent control has been obtained either with prn use of an inhaled combination of a short acting beta2 agonist (SABA) and an ICS, or with a short course of 10 days high dose ICS at the start of exacerbations. In moderate-severe asthma regularly treated with inhaled ICS/LABA combination, the symptom-driven use of the same inhaled ICS/LABA combination as reliever is superior to the symptom-driven use of SABA or LABA alone.

Study Design

Study Type:
Interventional
Actual Enrollment :
860 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
As Needed Budesonide/Formoterol Combination Versus Regular Budesonide/Formoterol Combination Plus as Needed Terbutaline in Mild-Moderate Persistent Asthma
Study Start Date :
Apr 1, 2009
Actual Primary Completion Date :
Apr 1, 2013
Actual Study Completion Date :
May 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: as needed medication

patients assigned to this arm will take bid inhaled placebo plus prn inhaled 160/4.5 mcg budesonide/formoterol combination

Drug: budesonide/formoterol combination (PRN)
budesonide/formoterol combination 160/4.5 mcg 1 inhalation used as needed for a period of 52 weeks
Other Names:
  • budesonide/formoterol combination

    • Drug: placebo
    bid inhaled placebo
    Active Comparator: guideline treatment

    bid inhaled 160/4.5 mcg budesonide/formoterol combination plus prn 500 mcg terbutaline

    Drug: budesonide/formoterol combination
    budesonide/formoterol 160/4.5 mcg 1 inhalation bid

    Drug: terbutaline
    as needed terbutaline 500 mcg for a period of 52 weeks

    Outcome Measures

    Primary Outcome Measures

    1. comparison between groups of the relative risk for treatment failure [52 weeks]

    Secondary Outcome Measures

    1. number of treatment failures [52 weeks]

    2. time to first treatment failure [52 weeks]

    3. differences between groups of lung function parameters, quality of life, symptoms score, use of as needed medication, adverse events [52 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Male or female out-patient aged from 18 years to 65 years

    • Clinical diagnosis of moderate persistent asthma for at least 6 months, according to GINA revised version 2006 guidelines

    • Post-bronchodilator forced expiratory volume (FEV1) at least 80% of the predicted

    • Either positive methacholine challenge test (PC20 FEV1< 4mg/ml or PD20 FEV1<0.8 mg) or positive response to the reversibility test in the last year

    • Asthma either not adequately controlled with low-dose (≤500 mcg beclomethasone or equivalent) inhaled corticosteroids (ICS) or controlled by bid inhaled combination of low-dose ICS/long acting beta-2 agonists (LABA)

    • A co-operative attitude and ability to be trained to correctly use the dry powder inhalator and to complete the diary cards

    • Written informed consent obtained

    Exclusion Criteria:

    • Inability to carry out pulmonary function testing

    • Moderate severe asthma associated with reduced lung function

    • History of near-fatal asthma and/or admission intensive care unit because of asthma

    • 3 or more courses of oral corticosteroids or hospitalization for asthma during the previous year

    • Diagnosis of COPD as defined by the GOLD guidelines

    • Evidence of severe asthma exacerbation or symptomatic infection of the airways in the previous 8 weeks

    • Current smokers or recent (less than one year) ex-smokers, defined as smoking at least 10 pack/years

    • History or current evidence of heart failure, coronary artery disease, myocardial infarction, severe hypertension, or cardiac arrhythmias

    • Diabetes mellitis

    • Percutaneous transluminal coronary angioplasty (PTCA) or coronary artery by-pass graft (CABG) during the previous six months

    • Abnormal ECG

    • Clinically significant or unstable concurrent diseases: uncontrolled hyperthyroidism, significant hepatic impairment, poorly controlled pulmonary disease (tuberculosis, active mycotic infection of the lung), gastrointestinal (e.g., active peptic ulcer), neurological or haematological autoimmune diseases

    • Malignancy

    • Any chronic diseases with prognosis < 2 years

    • Pregnant or lactating females or not able to exclude pregnancy during the study period

    • History of alcohol or drug abuse

    • Patients treated with monoamine oxidase inhibitors, tricyclic antidepressants or beta-blockers as regular use

    • Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients

    • Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study

    • Patients who received any investigational new drug within the last 12 weeks

    • Patients who have been previously enrolled in this study

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ospedale regionale Umberto I, Unità Operativa di Allergologia Ancona AN Italy
    2 Fondazione S. Maugeri - IRCCS -dipartimento di Pneumologia riabilitativa Cassano delle Murge BA Italy
    3 Dipartimento di Scienze Mediche-Unità Operativa di Pneumologia Benevento BN Italy 82100
    4 Policlinico Sant'Orsola Malpighi, Unità Operativa di Pneumologia Bologna BO Italy
    5 Università degli Studi di Catania, Unità operativa di Pneumologia Catania CT Italy
    6 Università Magna Grecia Catanzaro, unità operativa di Pneumologia Catanzaro CZ Italy
    7 Ospedale Morgagni Pierantoni, azienda Ospedaliera di Forlì, Unitaà operativa di Pneumologia Forlì FC Italy
    8 UNIVERSITà DEGLI STUDI DI FERRARA, CLINICA DI MALATTIE DELL'APPARATO RESPIRATORIO Ferrara FE Italy 44100
    9 Università degli studi di Foggia, ospedale pneumologico D'Avanzo, unità operativa di malattie dell'apparato respiratorio Foggia FG Italy
    10 Ospadale San Carlo Borromeo - Unità operativa di Pneumologia Milano MI Italy
    11 Ospedale città di Sesto San Giovanni, Unità operativa di Pneumologia Sesto San Giovanni MI Italy
    12 Università di Modena e Reggio Emilia, Unità operativa di Pneumologia Modena MO Italy
    13 Università degli Studi di Palermo, Ospedale "V. Cervello" Palermo Pa Italy 90146
    14 Università degli studi di Padova, dipartimento di Pneunmologia Padova PD Italy
    15 Università degli studi di Padova, Medicina del Lavoro Padova PD Italy
    16 Università degli studi di Pisa, Ospedale Cisanello, unità operativa di Pneumologia Pisa PI Italy
    17 Università degli stiudi di Parma, unità operativa di Pneumologia Parma PR Italy
    18 IRCCS Fondazione S Maugeri, Dipartimento di Allergologia Pavia PV Italy
    19 Università degli studi di Pavia, dipartimento di Pneumologia Pavia PV Italy
    20 università Cattolica del Sacro Cuore, Columbus, unità operativa di allergologia Roma RM Italy
    21 Università Cattolica del Sacro Cuore, Policlinico Gemelli, unità operativa di Pneumologia Roma RM Italy
    22 Università Roma La Sapienza, servizio di Fisiopatologia respiratoria Roma RM Italy
    23 Università di Perugia -Terni, Medcina del lavoro Terni Terni TI Italy
    24 Università degli studi di Torino, Dipartimento di scienze biomediche ed oncologia umana Torino TO Italy
    25 Ospedale di Cattinara, unità operativa di pneumologia Trieste TS Italy
    26 Ospedale di Bussolengo, Unità operativa di Pneumologia Bussolengo VR Italy
    27 azienda universitaria-ospedaliera istituti ospitalieri di Verona, unità operativa di Allergologia Verona VR Italy
    28 Servizio Pneumologico ASL Brindisi Brindisi Italy
    29 Seconda Università degli stuidi di Napoli, unità Operativa di Pneumologia Napoli Italy
    30 Giuseppina Bertorelli Parma Italy 43100
    31 Università di Roma Tor Vergata, unità di malattie dell'apparato Respiratorio Roma Italy

    Sponsors and Collaborators

    • Università degli Studi di Ferrara

    Investigators

    • Principal Investigator: Alberto Papi, MD, Università degli Studi di Ferrara

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Alberto Papi, MD, Professor, Università degli Studi di Ferrara
    ClinicalTrials.gov Identifier:
    NCT00849095
    Other Study ID Numbers:
    • AIFA-ASMA-BF-001
    • EudraCT number: 2008-004127-36
    First Posted:
    Feb 23, 2009
    Last Update Posted:
    May 30, 2014
    Last Verified:
    May 1, 2014
    Keywords provided by Alberto Papi, MD, Professor, Università degli Studi di Ferrara
    Adult
    Asthma
    Bronchodilator Agents
    Budesonide
    Double-Blind Method
    Drug Therapy, Combination
    Ethanolamines
    Female
    Forced Expiratory Volume
    Humans
    Male
    Terbutaline
    Additional relevant MeSH terms:
    Asthma
    Budesonide
    Terbutaline
    Formoterol Fumarate
    Budesonide, Formoterol Fumarate Drug Combination

    Study Results

    No Results Posted as of May 30, 2014