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Bronchial AsthmaPhase 3NCT00413387

Efficacy and Tolerability of Beclomethasone Dipropionate 100 µg + Formoterol 6 µg pMDI Via HFA-134a Vs. Budesonide 160 µg + Formoterol 4,5 µg Dry Powder Via Turbuhaler®. (Symbicort®)

A Phase 3 study testing beclomethasone dipropionate plus formoterol fumarate combination and budesonide plus formoterol combination in people with Bronchial Asthma, run by Chiesi Farmaceutici S.p.A. at 13 sites in 3 countries.

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

The aim of this study was to compare the efficacy and tolerability of the fixed combination beclomethasone/formoterol pMDI with that of budesonide/formoterol dry powder via Turbuhaler. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Bronchial Asthma
What is being tested?
beclomethasone dipropionate plus formoterol fumarate combination and budesonide plus formoterol combination
Could I receive a placebo?
No, everyone receives an active treatment
How many people
219 participants
Where
13 sitesin 3 countries
Study dates
Sep 2004to Oct 2005
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

  • Clinical diagnosis of moderate to severe persistent asthma for at least 6 months, according to GINA revised version 2002 guidelines:
  • Forced expiratory volume (FEV1) or peak expiratory flow rate (PEFR) > 50% and < 80% of the predicted normal;
  • Asthma not adequately controlled with the current therapies, defined as presence of daily asthma symptoms > once a week and night-time asthma symptoms > twice a month, and daily use of short-acting β2-agonists. These findings are to be based on recent medical history and are to be confirmed in the 2-week run-in period.
  • Treatment with inhaled corticosteroids at a daily dose ≤ 1000 μg of BDP or equivalent. The daily dose of inhaled corticosteroids taken at visit 1 will be assessed taking into account the following ratios between the doses of the different steroids: fluticasone propionate : BDP CFC = 1 : 2; budesonide : BDP CFC = 4 : 5; flunisolide : BDP CFC = 1 : 1. The ratios between inhaled steroids are irrespective of the formulations (i.e. spray aerosol or powder) used. When BDP is given in the new extra-fine HFA-134a formulation (as QVAR®, 3M Healthcare), the ratio with BDP CFC is set as 2 : 5. Therefore, the maximum allowed daily dose of inhaled corticosteroids at study entry will be: budesonide 800 μg, fluticasone propionate 500 μg, flunisolide 1000 μg, BDP 1000 mcg, BDP HFA extra-fine 400 μg.
  • Positive response to the reversibility test in the screening visit, defined as an increase of at least 12% (or, alternatively, of 200mL) from baseline value in the measurement of FEV1 30 minutes following 2 puffs (2 x 100 µg) of inhaled salbutamol administered via pMDI. The reversibility test can be avoided in patients having a documented positive response in the previous 6 months.
  • A co-operative attitude and ability to be trained to correctly use the metered dose inhalers and to complete the diary cards.
  • Written informed consent obtained.
  • At the end of the 2-week run-in period, the presence of daily asthma symptoms (of at least mild intensity) and nighttime asthma symptom (of at least mild intensity) > once a week, as well as of daily use of relief salbutamol is to be confirmed by reviewing the diary cards for run-in

Who cannot join

  • Inability to carry out pulmonary function testing;
  • Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) as defined by the National Heart Lung and Blood Institute/World Health Organisation (NHLBI/WHO) Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines (30);
  • History of near fatal asthma;
  • Evidence of severe asthma exacerbation or 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;
  • Patients treated with long-acting β2-agonists, anticholinergics and antihistamines during the previous 2 weeks, with topical or intranasal corticosteroids and leukotriene antagonists during the previous 4 weeks;
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  • Patients who have changed their dose of inhaled corticosteroids during the previous 4 weeks, or treatment with inhaled corticosteroids at a daily dose > 1000 μg of BDP or equivalent (except for extra-fine formulations, see inclusion criteria);
  • Current smokers or recent (less than one year) ex-smokers, defined as smoking at least 10 cigarettes/day;
  • History or current evidence of heart failure, coronary artery disease, myocardial infarction, severe hypertension, cardiac arrhythmias;
  • Diabetes mellitus;
  • Percutaneous transluminal coronary angioplasty (PTCA) or coronary artery by-pass graft (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;
  • Pregnant or lactating females or females at risk of pregnancy, i.e. those not demonstrating adequate contraception (i.e. barrier methods, intrauterine devices, hormonal treatment or sterilization). A pregnancy test is to be carried out in women of a fertile age.
  • 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;
  • At the end of the run-in period, patients will not be admitted to the treatment period in the case of an increase of PEFR (L/sec) measured at the clinics at the end of the run-in period > 15% in respect of values measured at the start of the run-in period;
  • Patients with asthma exacerbations during the run-in period will also be excluded from the study.

Trial locations and contacts

13 sites in 3 countries.

13 sites in 3 countries

Poland6 sites

  • Nzoz "Medex"Poradnia Alergologiczna

    Bielsko-Biala

  • Centrum Uslug Medycznych

    Krakow

  • Centrum Alergologii

    Lodz

  • Prywatny Gabinet Lekarski

    Lodz

  • Uniwersytet Medyczny

    Lodz

  • Nzoz Lekarze Specjalisci

    Wroclaw

Other trials in Poland

Ukraine6 sites

  • Internal Medicine Department, Dniepropetrovsk State Medical Academy. City Clinical Hospital no. 4

    Dniepropetrovsk

  • Institute of Therapy, Ukranian Academy of Medical Science. Pulmonological Departement

    Kharkiv

  • Kharkov Regional Clinical Hospital. Pulmonological and Allergological Department

    Kharkiv

  • Institute of Phthisiology and Pulmonology Academy of Medical Science of the Ukraine, Pulmonology Departement

    Kiev

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

    Kiev

  • Kiev Medical Academy of Postdiploma Education. Department of Medical Genetics, Clinical Immunology and Allergology

    Kiev

Other trials in Ukraine

Austria1 site

  • Ambulance For Paediatric and Pulmonology

    Vienna

Other trials in Austria

About this study

Official title: Double Blind, Double Dummy, Multinational, Multicentre, Parallel-Group Design Clinical Trial of the Efficacy and Tolerability of CHF 1535 (Beclomethasone Dipropionate 100 µg + Formoterol 6 µg) pMDI Via HFA-134a Vs. Budesonide 160 µg + Formoterol 4,5 µg Dry Powder Via Turbuhaler® (Symbicort®) in the 12-Week Treatment of Adult Patients With Moderate to Severe Persistent Asthma

The aim of this study was to compare the efficacy and tolerability of the fixed combination beclomethasone/formoterol pMDI with that of budesonide/formoterol dry powder via Turbuhaler.

Read the detailed description

Asthma is a chronic disease that is estimated to affect over 25 million people both in the U.S. and in Europe (i.e. approximately 10% of the total population). Pharmacological therapy is used to treat reversible airway obstruction, inflammation and hyper-reactivity. Medications include preventive treatments in forms of antinflammatory/antiallergic agents (i.e. glucocorticosteroids, leukotriene antagonists, cromolyn sodium) and reliever treatments, in forms of bronchodilators (i.e. β-adrenergic agonists, anticholinergics). In patients treated with inhaled glucocorticosteroids whose asthma is not fully controlled, national and international guidelines recommend a stepwise approach. Recent evidence-based clinical trials show that the addition of a LABA to inhaled glucocorticosteroids is more beneficial in terms of asthma control than increasing the dose of corticosteroids alone.

COMPARISONS: CHF 1535 (BECLOMETHASONE DIPROPIONATE 100 µg+ FORMOTEROL 6 µg) pMDI via HFA-134a compared to SYMBICORT (BUDESONIDE 160 µg + FORMOTEROL 4,5 µg).

Being tested
beclomethasone dipropionate plus formoterol fumarate combination, budesonide plus formoterol combination
Keywords
Asthma, Combinations, Inhaled therapy, Corticosteroids, Long acting bronchodilators, Beclomethasone, Formoterol, Budesonide
Medical subject headings
Asthma

What participants receive

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

  • beclomethasone dipropionate plus formoterol fumarate combinationDrug

    100mcg beclomethasone diproprionate plus 6 mcg formoterol

  • budesonide plus formoterol combinationDrug

    200mcg budesonide plus 6 mcg formoterol

Study groups in NCT00413387
Study groupRoleWhat they receive
1Experimentalchf1535
Receives: Drug: beclomethasone dipropionate plus formoterol fumarate combination
2Active comparatorSymbicort
Receives: Drug: budesonide plus formoterol combination

What is being measured

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

  1. Morning Peak Expiratory Flow (PEF) daily measured by patients.

    Measured: morning approximately 8:00

Secondary outcomes (13)

  1. Evening PEF measured by patients daily.

    Measured: evening approximately 20:00

  2. FEV1 measured by patients daily.

    Measured: morning and evening

  3. Standard pulmonary function tests measured at clinics at 2, 4, 8 and 12 weeks.

    Measured: morning before drug intake

  4. Change in FEV1 and PEF from pre-dose to 5, 15, 30 and 60 minutes after study drug intake at week 0 and 12.

    Measured: morning post drug intake

  5. Symptoms scores measured by patients daily.

    Measured: morning and evening

  6. symptoms'free days measured by patients daily.

    Measured: daily

  7. Use of relief salbutamol measured by patients daily.

    Measured: daily

  8. Frequency of asthma exacerbations evaluated at 2, 4, 8 and 12 weeks.

    Measured: morning of the visits retrospective assessment

  9. Adverse event and adverse drug reaction daily.

    Measured: morning of visits retrospective assesment

  10. ECG (with QTc interval)at 0 and 12 weeks.

    Measured: morning of start and end of treatment visits

  11. Vital signs (heart rate and blood pressure) at 2, 4, 8 and 12 weeks

    Measured: morning of visits

  12. Use of relief salbutamol.

    Measured: daily

  13. Frequency of asthma exacerbations.

    Measured: at visits

Timeline

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

  1. First posted19 Dec 2006 (estimated)
  2. Study startSep 2004
  3. Primary completionAug 2005
  4. Study completionOct 2005

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
219 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00413387
Sponsor's protocol ID
MC/PR/033011/002/03
Status last verified
Jul 2020
First submitted
18 Dec 2006
Last updated
3 Aug 2020
Results posted
No
Data monitoring committee
No

Publications

  • Papi A, Paggiaro PL, Nicolini G, Vignola AM, Fabbri LM; Inhaled Combination Asthma Treatment versus SYmbicort (ICAT SY) Study Group. Beclomethasone/formoterol versus budesonide/formoterol combination therapy in asthma. Eur Respir J. 2007 Apr;29(4):682-9. doi: 10.1183/09031936.00095906. Epub 2006 Nov 15.

    PubMed 17107988

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing beclomethasone dipropionate plus formoterol fumarate combination and budesonide plus formoterol combination in people with Bronchial Asthma, run by Chiesi Farmaceutici S.p.A. at 13 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 24 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 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in Poland, Ukraine, Austria. 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 Peak Expiratory Flow (PEF) daily measured by patients. (time frame: morning approximately 8:00). 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 NCT00413387, 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 3 Aug 2020.

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