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AsthmaPhase 3NCT00849095

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

A Phase 3 study testing budesonide/formoterol combination (PRN), budesonide/formoterol combination and terbutaline in people with Asthma, run by Università degli Studi di Ferrara at 31 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Asthma
What is being tested?
budesonide/formoterol combination (PRN), budesonide/formoterol combination and terbutaline
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
860 participants
Where
31 sitesItaly
Study dates
Apr 2009to May 2013
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 21Show fewer
  • 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

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

Italy31 sites

  • Ospedale regionale Umberto I, Unità Operativa di Allergologia

    Ancona, AN

  • Dipartimento di Scienze Mediche-Unità Operativa di Pneumologia

    Benevento, BN, 82100

  • Policlinico Sant'Orsola Malpighi, Unità Operativa di Pneumologia

    Bologna, BO

  • Servizio Pneumologico ASL Brindisi

    Brindisi

  • Ospedale di Bussolengo, Unità operativa di Pneumologia

    Bussolengo, VR

  • Fondazione S. Maugeri - IRCCS -dipartimento di Pneumologia riabilitativa

    Cassano delle Murge, BA

  • Università degli Studi di Catania, Unità operativa di Pneumologia

    Catania, CT

  • Università Magna Grecia Catanzaro, unità operativa di Pneumologia

    Catanzaro, CZ

  • UNIVERSITà DEGLI STUDI DI FERRARA, CLINICA DI MALATTIE DELL'APPARATO RESPIRATORIO

    Ferrara, FE, 44100

  • Università degli studi di Foggia, ospedale pneumologico D'Avanzo, unità operativa di malattie dell'apparato respiratorio

    Foggia, FG

  • Ospedale Morgagni Pierantoni, azienda Ospedaliera di Forlì, Unitaà operativa di Pneumologia

    Forlì, FC

  • Ospadale San Carlo Borromeo - Unità operativa di Pneumologia

    Milan, MI

  • Università di Modena e Reggio Emilia, Unità operativa di Pneumologia

    Modena, MO

  • Seconda Università degli stuidi di Napoli, unità Operativa di Pneumologia

    Naples

  • Università degli studi di Padova, dipartimento di Pneunmologia

    Padova, PD

  • Università degli studi di Padova, Medicina del Lavoro

    Padova, PD

  • Università degli Studi di Palermo, Ospedale "V. Cervello"

    Palermo, Pa, 90146

  • Giuseppina Bertorelli

    Parma, Parma, 43100

  • Università degli stiudi di Parma, unità operativa di Pneumologia

    Parma, PR

  • IRCCS Fondazione S Maugeri, Dipartimento di Allergologia

    Pavia, PV

  • Università degli studi di Pavia, dipartimento di Pneumologia

    Pavia, PV

  • Università degli studi di Pisa, Ospedale Cisanello, unità operativa di Pneumologia

    Pisa, PI

  • università Cattolica del Sacro Cuore, Columbus, unità operativa di allergologia

    Roma, RM

  • Università Cattolica del Sacro Cuore, Policlinico Gemelli, unità operativa di Pneumologia

    Roma, RM

  • Università Roma La Sapienza, servizio di Fisiopatologia respiratoria

    Roma, RM

  • Università di Roma Tor Vergata, unità di malattie dell'apparato Respiratorio

    Roma

  • Ospedale città di Sesto San Giovanni, Unità operativa di Pneumologia

    Sesto San Giovanni, MI

  • Università di Perugia -Terni, Medcina del lavoro Terni

    Terni, TI

  • Università degli studi di Torino, Dipartimento di scienze biomediche ed oncologia umana

    Torino, TO

  • Ospedale di Cattinara, unità operativa di pneumologia

    Trieste, TS

  • azienda universitaria-ospedaliera istituti ospitalieri di Verona, unità operativa di Allergologia

    Verona, VR

Other trials in Italy

About this study

Official title: As Needed Budesonide/Formoterol Combination Versus Regular Budesonide/Formoterol Combination Plus as Needed Terbutaline in Mild-Moderate Persistent Asthma

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).

Read the 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.

Conditions
Asthma
Being tested
budesonide/formoterol combination (PRN), budesonide/formoterol combination, placebo, terbutaline
Keywords
Adult, Asthma, Bronchodilator Agents, Budesonide, Double-Blind Method, Drug Therapy, Combination, Ethanolamines, Female, Forced Expiratory Volume, Humans, Male, Terbutaline
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • budesonide/formoterol combination (PRN)Drug

    Also called budesonide/formoterol combination

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

  • budesonide/formoterol combinationDrug

    budesonide/formoterol 160/4.5 mcg 1 inhalation bid

  • placeboDrug

    bid inhaled placebo

  • terbutalineDrug

    as needed terbutaline 500 mcg for a period of 52 weeks

Study groups in NCT00849095
Study groupRoleWhat they receive
as needed medicationExperimentalpatients assigned to this arm will take bid inhaled placebo plus prn inhaled 160/4.5 mcg budesonide/formoterol combination
Receives: Drug: budesonide/formoterol combination (PRN); Drug: placebo
guideline treatmentActive comparatorbid inhaled 160/4.5 mcg budesonide/formoterol combination plus prn 500 mcg terbutaline
Receives: Drug: budesonide/formoterol combination; Drug: terbutaline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. comparison between groups of the relative risk for treatment failure

    Measured: 52 weeks

Secondary outcomes (3)

  1. number of treatment failures

    Measured: 52 weeks

  2. time to first treatment failure

    Measured: 52 weeks

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

    Measured: 52 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Feb 2009 (estimated)
  2. Study startApr 2009
  3. Primary completionApr 2013
  4. Study completionMay 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
860 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00849095
Sponsor's protocol ID
AIFA-ASMA-BF-001
Other IDs
EudraCT number: 2008-004127-36
Status last verified
May 2014
First submitted
20 Feb 2009
Last updated
30 May 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 25481378

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing budesonide/formoterol combination (PRN), budesonide/formoterol combination and terbutaline in people with Asthma, run by Università degli Studi di Ferrara at 31 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

comparison between groups of the relative risk for treatment failure (time frame: 52 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00849095, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2014.

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