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AsthmaPhase 3FORTENCT00497237

Clinical Trial of the Efficacy and Safety of Beclomethasone Dipropionate Plus Formoterol vs Fluticasone Propionate Plus Salmeterol in the 6 Months Step Down Treatment of Asthma

A Phase 3 study testing Beclomethasone plus formoterol fixed combination and Fluticasone plus salmeterol fixed combination in people with Asthma, run by Chiesi Farmaceutici S.p.A. at 18 sites in 3 countries.

Completed

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

Official record
Search all trials

Trial summary

Asthma is a serious global health problem. People of all ages in countries throughout the world are affected by this chronic airway disorder that can be severe and sometimes fatal. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Asthma
What is being tested?
Beclomethasone plus formoterol fixed combination and Fluticasone plus salmeterol fixed combination
Could I receive a placebo?
No, everyone receives an active treatment
How many people
382 participants
Where
18 sitesin 3 countries
Study dates
Apr 2007to Mar 2010
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

  • Patients will be enrolled for screening at Visit 1 into the run-in period if they meet all the following criteria:
  • Clinical diagnosis of moderate persistent asthma for at least 6 months, according to GINA revised version 2005 guidelines 1 and considering current treatment;
  • Forced expiratory volume (FEV1) or peak expiratory flow rate (PEFR) ≥ 80% of the predicted normal value;
  • Treated with fluticasone 1000 mcg + salmeterol 100 mcg daily for at least 4 weeks at a stable dose;
  • Reporting no nocturnal symptoms or awakenings, no exacerbations, no limitations of activities, symptoms in ≤2 days and use of rescue medication ≤2 days per week, in the last 4 weeks;
  • Exhibiting a co-operative attitude and ability to be trained to correctly use the study devices and to complete the diary cards.
  • At the end of run in period (Week 8+0; Visit 3), patients will be recruited into the treatment period and randomized to treatment if they meet the following criterion:
  • Asthma is controlled 1 in each of the last 4 weeks of run-in (no nocturnal symptoms or awakenings; no exacerbations; no limitations of activities; symptoms in ≤2 days; use of rescue medication ≤2 days; morning PEF ≥80% of predicted in every day) confirmed by reviewing the diary cards.

Who cannot join

  • Inability to carry out pulmonary function testing;
  • Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) as defined by the NHLBI/WHO's GOLD guidelines;
  • Current smokers or recent (less than one year) ex-smokers with a smoking history of ≥10 pack/years;
  • History of near fatal asthma;
  • Evidence of symptomatic infection of the airways in the previous 8 weeks;
  • Three or more courses of oral corticosteroids or hospitalisation due to asthma during the previous 6 months;
Show all 19Show fewer
  • Patients treated with anticholinergics and antihistamines during the previous 2 weeks, with topical or intranasal corticosteroids and leukotriene antagonists during the previous 4 weeks;
  • History or current evidence of heart failure, coronary artery disease, myocardial infarction, severe hypertension, cardiac arrhythmias;
  • Diabetes mellitus;
  • PTCA or CABG during the previous six months;
  • Patients with an abnormal QTc interval value in the ECG test, defined as >450 msec in males or > 470 msec in females;
  • Other haemodynamic relevant rhythm disturbances (including atrial flutter or atrial fibrillation with ventricular response, bradycardia (≤55 bpm), evidence of atrial-ventricular (AV) block on ECG of more than 1st degree;
  • Clinically significant or unstable concurrent diseases: uncontrolled hyperthyroidism, significant hepatic impairment, poorly controlled pulmonary (tuberculosis, active mycotic infection of the lung), gastrointestinal (e.g. active peptic ulcer), neurological or haematological autoimmune diseases;
  • Cancer or any chronic diseases with prognosis <2 years;
  • 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 who received any investigational new drug within the last 12 weeks;
  • At the end of run in period (Week 8+0; Visit 3), patients will not be randomized to treatment if they do not completely meet the definition of "controlled asthma". These subjects will be considered screening failures and will not count against the planned number to be recruited.

Trial locations and contacts

18 sites in 3 countries.

18 sites in 3 countries

Ukraine10 sites

  • Department of Hospital Pediatrics Crimean State Medical University. Pulmonology Department of Republican Clinical Children's Hospital

    Crimea, 95004

  • Pulmonological and Allergological Department of the Kharkov Regional Clinical Hospital

    Kharkiv, 61022

  • Pulmonological Department #2

    Kharkiv, 61035

  • Pulmonological Department of the Institute of Therapy, Ukrainian Academy of Medical Sciences

    Kharkiv, 61035

  • Department of General Practice- Family medicine. Medical Academy of postgraduate education.

    Kharkiv

  • Department of Diagnostic, Therapy and Clinical Pharmacology of Lung Diseases of the Institute of Phthisiology and Pulmonology Academy of Medical Science of the Ukraine

    Kiev, 03680

  • Institute of pthysiology and pulmonology Academy of medical science of the Ukraine.

    Kiev, 03680

  • Pulmonology Department of the Institute of Phthisiology and Pulmonology AMS of the Ukraine

    Kiev, 03680

  • Clinical Hospital 8, Department of pediatrics and clinical laboratories

    Kryvyi Rih

  • Department of Hospital Therapy of Lugansk State Medical Institute. Lugansk Regional Clinical Hospital

    Luhansk, 91045

Other trials in Ukraine

Bulgaria4 sites

  • Clinic of Pulmonology, UMHAT "Sveti Georgi"

    Plovdiv, 4002

  • First Department of Pulmonology, Regional Dispensery of Pulmonology and Phtisiatric Diseases with Stationary (RDPPDS)

    Rousse, 7002

  • Clinic of Pulmonology, University Hospital "Lozenetz"

    Sofia

  • First Internal Clinic, Endocrinology and Pulmonology Department MHAT

    Stara Zagora, 6000

Other trials in Bulgaria

Italy4 sites

  • U.O.C. S.Anna e S. Sebastiano - Malattie dell'apparato respiratorio

    Caserta

  • Ospedale S. Camillo de Lellis - U.O.C. Pneumologia

    Chieti

  • Ospedale Cardarelli - Fisiopatologia Respiratoria

    Naples

  • CNR - Dipartimento di Fisiopatologia Respiratoria

    Palermo

Other trials in Italy

About this study

Official title: Prospective, Randomised, Open-label, Multicentre, Active Drug Controlled, Parallel Group Design Clinical Trial of the Efficacy and Safety of Beclomethasone Dipropionate 400 mcg + Formoterol 24 mcg pMDI Via HFA-134a (Foster™) vs. Fluticasone Propionate 500 mcg + Salmeterol Xinafoate 100 mcg DPI (Seretide Diskus®) in the 6 Months Stepdown Treatment of Adult Patients With Controlled Asthma

Asthma is a serious global health problem. People of all ages in countries throughout the world are affected by this chronic airway disorder that can be severe and sometimes fatal. The prevalence of asthma is increasing everywhere, especially among children.According to international guidelines, once control of asthma is achieved and maintained for at least 3 months, a gradual reduction of the maintenance therapy should be tried in order to identify the minimum therapy required to maintain control. This will help reduce the risk of side effects and enhance patient adherence to the treatment plan.

Reduction of therapy in patients on combination therapy should begin with a reduction in the dose of inhaled glucocorticosteroid.1 The present study is designed to evaluate if patients with controlled asthma treated with FP 1000 mcg + salmeterol 100 mcg daily can be stepped down. Stepping-down will be attempted with two medications: a new combination of extrafine beclomethasone dipropionate 400 mcg + formoterol 24 mcg daily (test medication, Foster™) and, alternatively, fluticasone propionate 500 mcg + salmeterol 100 mcg daily(reference medication) without losing asthma control.If this hypothesis will be confirmed, the present study will demonstrate that asthma control can be maintained with less than half the dose of inhaled corticosteroid and with less medical costs.

Given the aims of this study, the population to be monitored includes adult patients with moderate persistent asthma, which can be defined controlled according to the current guidelines under standard stabilised treatment. The intended treatment duration is therefore designed to ensure that good control of asthma is firmly achieved before stepping down the treatment (8 weeks run-in period), but also that the condition of the patients are followed long enough (24 weeks comparative treatment period) to ensure that a new stable condition is also obtained and properly monitored.

Conditions
Asthma
Being tested
Beclomethasone plus formoterol fixed combination, Fluticasone plus salmeterol fixed combination
Keywords
Asthma, Stepdown, Beclomethasone, Formoterol, Corticosteroids
Medical subject headings
Asthma

What participants receive

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

  • Beclomethasone plus formoterol fixed combinationDrug

    100+6 pMDI

  • Fluticasone plus salmeterol fixed combinationDrug

    diskus 250/50

Study groups in NCT00497237
Study groupRoleWhat they receive
1ExperimentalFoster
Receives: Drug: Beclomethasone plus formoterol fixed combination
2Active comparatorSeretide
Receives: Drug: Fluticasone plus salmeterol fixed combination

What is being measured

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

  1. Morning pre-dose PEF measured daily by patients (mean of the last 2 weeks of treatment period).

    Measured: mean of the last 2 weeks of treatment period

Secondary outcomes (11)

  1. symptom scores and symptom free days

    Measured: in the whole study period and every 2-week period

  2. morning and evening pre-dose PEF and FEV1 measured daily by patients;

    Measured: daily and mean each 2-week period

  3. pulmonary function tests measured at clinics (pre-dose PEF, FVC and FEV1);

    Measured: at aech clinic visit

  4. change of FEV1 from pre-dose to 5, 15, 30 and 60 minutes post-dose;

    Measured: randomization visit and end of treatment visit

  5. number, frequency and severity of exacerbations, time to first exacerbation

    Measured: whole study period

  6. adverse events and adverse drug reactions

    Measured: retrospectively assessed at each visit

  7. use of relief salbutamol and days without use of relief salbutamol;

    Measured: daily

  8. proportion of patients with controlled asthma and partly controlled asthma, weeks of controlled asthma and partly controlled asthma;

    Measured: weekly

  9. pharmaco-economic analysis of medical and non medical costs.

    Measured: during study period

  10. 12 h-overnight urinary cortisol/creatinine

    Measured: (collected at visit 3, 6 and 9)

  11. vital signs

    Measured: at each visit

Timeline

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

  1. First posted6 Jul 2007 (estimated)
  2. Study startApr 2007
  3. Primary completionMar 2010
  4. Study completionMar 2010

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
None (open label)
Enrolment
382 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00497237
Sponsor's protocol ID
MC/PR/033011/005/06
Other IDs
2006-005349-13
Acronym
FORTE
Status last verified
Mar 2017
First submitted
4 Jul 2007
Last updated
30 Mar 2017
Results posted
No
Data monitoring committee
No

Publications

  • Papi A, Nicolini G, Crimi N, Fabbri L, Olivieri D, Rossi A, Paggiaro P. Step-down from high dose fixed combination therapy in asthma patients: a randomized controlled trial. Respir Res. 2012 Jun 25;13(1):54. doi: 10.1186/1465-9921-13-54.

    PubMed 22731754

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Beclomethasone plus formoterol fixed combination and Fluticasone plus salmeterol fixed combination in people with Asthma, run by Chiesi Farmaceutici S.p.A. at 18 sites in 3 countries.

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 8 inclusion and 19 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 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Ukraine, Bulgaria, 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?

Morning pre-dose PEF measured daily by patients (mean of the last 2 weeks of treatment period). (time frame: mean of the last 2 weeks of treatment period). 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 NCT00497237, 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 Mar 2017.

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