Prn Budesonide/Formoterol Versus Regular Budesonide/Formoterol Plus Prn Terbutaline in Mild-Moderate Asthma
As Needed Budesonide/Formoterol Combination Versus Regular Budesonide/Formoterol Combination Plus as Needed Terbutaline in Mild-Moderate Persistent Asthma
2 other identifiers
interventional
860
1 country
31
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 asthma
Started Apr 2009
Longer than P75 for phase_3 asthma
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 20, 2009
CompletedFirst Posted
Study publicly available on registry
February 23, 2009
CompletedStudy Start
First participant enrolled
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedMay 30, 2014
May 1, 2014
4 years
February 20, 2009
May 29, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
comparison between groups of the relative risk for treatment failure
52 weeks
Secondary Outcomes (3)
number of treatment failures
52 weeks
time to first treatment failure
52 weeks
differences between groups of lung function parameters, quality of life, symptoms score, use of as needed medication, adverse events
52 weeks
Study Arms (2)
as needed medication
EXPERIMENTALpatients assigned to this arm will take bid inhaled placebo plus prn inhaled 160/4.5 mcg budesonide/formoterol combination
guideline treatment
ACTIVE COMPARATORbid inhaled 160/4.5 mcg budesonide/formoterol combination plus prn 500 mcg terbutaline
Interventions
budesonide/formoterol combination 160/4.5 mcg 1 inhalation used as needed for a period of 52 weeks
budesonide/formoterol 160/4.5 mcg 1 inhalation bid
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (31)
Ospedale regionale Umberto I, Unità Operativa di Allergologia
Ancona, AN, Italy
Fondazione S. Maugeri - IRCCS -dipartimento di Pneumologia riabilitativa
Cassano delle Murge, BA, Italy
Dipartimento di Scienze Mediche-Unità Operativa di Pneumologia
Benevento, BN, 82100, Italy
Policlinico Sant'Orsola Malpighi, Unità Operativa di Pneumologia
Bologna, BO, Italy
Università degli Studi di Catania, Unità operativa di Pneumologia
Catania, CT, Italy
Università Magna Grecia Catanzaro, unità operativa di Pneumologia
Catanzaro, CZ, Italy
Ospedale Morgagni Pierantoni, azienda Ospedaliera di Forlì, Unitaà operativa di Pneumologia
Forlì, FC, Italy
UNIVERSITà DEGLI STUDI DI FERRARA, CLINICA DI MALATTIE DELL'APPARATO RESPIRATORIO
Ferrara, FE, 44100, Italy
Università degli studi di Foggia, ospedale pneumologico D'Avanzo, unità operativa di malattie dell'apparato respiratorio
Foggia, FG, Italy
Ospadale San Carlo Borromeo - Unità operativa di Pneumologia
Milan, MI, Italy
Ospedale città di Sesto San Giovanni, Unità operativa di Pneumologia
Sesto San Giovanni, MI, Italy
Università di Modena e Reggio Emilia, Unità operativa di Pneumologia
Modena, MO, Italy
Giuseppina Bertorelli
Parma, Parma, 43100, Italy
Università degli Studi di Palermo, Ospedale "V. Cervello"
Palermo, Pa, 90146, Italy
Università degli studi di Padova, dipartimento di Pneunmologia
Padua, PD, Italy
Università degli studi di Padova, Medicina del Lavoro
Padua, PD, Italy
Università degli studi di Pisa, Ospedale Cisanello, unità operativa di Pneumologia
Pisa, PI, Italy
Università degli stiudi di Parma, unità operativa di Pneumologia
Parma, PR, Italy
IRCCS Fondazione S Maugeri, Dipartimento di Allergologia
Pavia, PV, Italy
Università degli studi di Pavia, dipartimento di Pneumologia
Pavia, PV, Italy
università Cattolica del Sacro Cuore, Columbus, unità operativa di allergologia
Roma, RM, Italy
Università Cattolica del Sacro Cuore, Policlinico Gemelli, unità operativa di Pneumologia
Roma, RM, Italy
Università Roma La Sapienza, servizio di Fisiopatologia respiratoria
Roma, RM, Italy
Università di Perugia -Terni, Medcina del lavoro Terni
Terni, TI, Italy
Università degli studi di Torino, Dipartimento di scienze biomediche ed oncologia umana
Torino, TO, Italy
Ospedale di Cattinara, unità operativa di pneumologia
Trieste, TS, Italy
Ospedale di Bussolengo, Unità operativa di Pneumologia
Bussolengo, VR, Italy
azienda universitaria-ospedaliera istituti ospitalieri di Verona, unità operativa di Allergologia
Verona, VR, Italy
Servizio Pneumologico ASL Brindisi
Brindisi, Italy
Seconda Università degli stuidi di Napoli, unità Operativa di Pneumologia
Napoli, Italy
Università di Roma Tor Vergata, unità di malattie dell'apparato Respiratorio
Roma, Italy
Related Publications (1)
Papi A, Marku B, Scichilone N, Maestrelli P, Paggiaro P, Saetta M, Nava S, Folletti I, Bertorelli G, Bertacco S, Contoli M, Plebani M, Barbaro MPF, Spanevello A, Aliani M, Pannacci M, Morelli P, Beghe B, Fabbri LM; AIFASMA Study Group. Regular versus as-needed budesonide and formoterol combination treatment for moderate asthma: a non-inferiority, randomised, double-blind clinical trial. Lancet Respir Med. 2015 Feb;3(2):109-119. doi: 10.1016/S2213-2600(14)70266-8. Epub 2014 Dec 4.
PMID: 25481378DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alberto Papi, MD
Università degli Studi di Ferrara
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
February 20, 2009
First Posted
February 23, 2009
Study Start
April 1, 2009
Primary Completion
April 1, 2013
Study Completion
May 1, 2013
Last Updated
May 30, 2014
Record last verified: 2014-05