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®)

NCT00413387 | Completed Phase 3

• 1 other identifier: MC/PR/033011/002/03
• Study Type: interventional
• Target: 219
• Locations: 3 countries
• Sites: 13

Brief 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.

Conditions

Bronchial Asthma

Keywords

Asthma; Combinations; Inhaled therapy; Corticosteroids; Long acting bronchodilators; Beclomethasone; Formoterol; Budesonide

Outcome Measures

Primary Outcomes (1)

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

  morning approximately 8:00

Secondary Outcomes (13)

• Evening PEF measured by patients daily.

  evening approximately 20:00

• FEV1 measured by patients daily.

  morning and evening

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

  morning before drug intake

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

  morning post drug intake

• Symptoms scores measured by patients daily.

  morning and evening

Study Arms (2)

1

EXPERIMENTAL

chf1535

Drug: beclomethasone dipropionate plus formoterol fumarate combination

2

ACTIVE COMPARATOR

Symbicort

Drug: budesonide plus formoterol combination

Interventions

beclomethasone dipropionate plus formoterol fumarate combination DRUG

100mcg beclomethasone diproprionate plus 6 mcg formoterol

1

budesonide plus formoterol combination DRUG

200mcg budesonide plus 6 mcg formoterol

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Chiesi Farmaceutici S.p.A.: lead

Study Sites (13)

Ambulance For Paediatric and Pulmonology

Vienna, Austria

Location

Nzoz "Medex"Poradnia Alergologiczna

Bielsko-Biala, Poland

Location

Centrum Uslug Medycznych

Krakow, Poland

Location

Centrum Alergologii

Lodz, Poland

Location

Prywatny Gabinet Lekarski

Lodz, Poland

Location

Uniwersytet Medyczny

Lodz, Poland

Location

Nzoz Lekarze Specjalisci

Wroclaw, Poland

Location

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

Dniepropetrovsk, Ukraine

Location

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

Kharkiv, Ukraine

Location

Kharkov Regional Clinical Hospital. Pulmonological and Allergological Department

Kharkiv, Ukraine

Location

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

Kiev, Ukraine

Location

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

Kiev, Ukraine

Location

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

Kiev, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 17107988 RESULT

MeSH Terms

Conditions

Asthma

Interventions

Beclomethasone; Budesonide

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Chlorinated; Pregnenediones; Pregnenes

Study Officials

• Leonardo M. Fabbri, MD

  Department of Resipiratory Diseases - University of Modena and Reggio Emilia, Modena, Italy

  STUDY CHAIR

• Maurizio A. Vignola, MD

  Institute of Lung Pathophysiology, National Research Council, Palermo, Italy

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 18, 2006
• First Posted: December 19, 2006
• Study Start: September 1, 2004
• Primary Completion: August 1, 2005
• Study Completion: October 1, 2005
• Last Updated: August 3, 2020

Record last verified: 2020-07

Locations

PL (6); UA (6); AU (1)